To Download - Stem Cells, Building Blocks for Tissue Engineering

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  • A pleasure to share the presentation with Dr Young, and a blessing to have such a colleague and resource.
    Morula
    Dolly – first mammal cloned
    Christopher Reeve – quadriplegic – would stem cell research have helped with spinal injury?
    Louise Brown with mum – test tube baby, 1978
  • Much has been written about the ethics of stem cells and it makes sense. Stem cells bring us to the beginning of life, and in the destruction of embryos, to the end. Stem cells offer perhaps the greatest hope for those who suffer from some malignancies, Lou Gehrig’s disease, and other disabling and often terminal conditions, and stem cells research presents with some of our greatest questions, what does it mean to be a unique human being when there is the possibility of cloning for instance. It is my task to lay out before you some of the issues facing researchers in this area. I do so in the spirit of a shared pursuit of ethical solutions, solutions which we may glimpse but, because the technologies are evolving as we speak, seem outnumbered by the growing number of questions.
  • Not cover areas in red – related, but a bit peripheral for 20 minutes alloted
  • Research in human stem cells has progressed so quickly we can barely get a grasp on current issues, and have much more difficulty anticipating ethical issues that may arise from new research. Here is an indication of how quickly research has moved.
  • The ethical framework I will bring to this is the standard medical ethical view based on the four most commonly recognized principles. Note that the key in arriving at a decision often derives from how we assign relative weights to these principles, i.e., to which do we assign greatest priority, and that, with an ethical dilemma, we are not faced with a black or white choice (otherwise it wouldn’t be a dilemma) but with a better or worse choice.
  • Existing stem cell lines from IVF, aborted fetuses
    2. Where do stem cells come from? Embryonic stem cells are derived from the inner cell mass of a blastocyst: the fertilized egg, called the zygote, divides and forms two cells; each of these cells divides again, and so on. Soon there is a hollow ball of about 150 cells called the blastocyst that contains two types of cells, the trophoblast and the inner cell mass. Embryonic stem cells are obtained from the inner cell mass.
    Stem cells can also be found in small numbers in various tissues in the fetal and adult body. For example, blood stem cells are found in the bone marrow that give rise to all specialized blood cell types. Such tissue-specific stem cells have not yet been identified in all vital organs, and in some tissues like the brain, although stem cells exist, they are not very active, and thus do not readily respond to cell injury or damage.
    Stem cells can also be obtained from other sources, for example, the umbilical cord of a newborn baby is a source of blood stem cells. Recently, scientists have also discovered the existence of cells in baby teeth and in amniotic fluid that may also have the potential to form multiple cell types. Research on these cells is at a very early stage.
    Recently, cells with properties similar to embryonic stem cells, referred to as induced pluripotent stem cells (iPS cells) have been engineered from somatic cells (see ‘What is are induced pluripotent stem cells?’).
    iPSC = induced Pluripotent Stem cells - Yamanaka
    Since the ban on new stem cell lines was lifted last year, the most common source for totipotent stem cells has been unused embryos from IVF.
    Induced Pluripotent Stem Cells
  • Louise brown b. 1978
    Louise Brown was told about her "miracle" birth as a young child
    It is 30 years since scientists held their breath as they waited for news of the world's first test tube baby. When Louise Brown was born - so was IVF treatment.
    Today, more than three million babies have been born around the world thanks to the technology which was pioneered in Britain.
    Louise's birth has been celebrated by IVF families and some of the clinical staff involved in the breakthrough.
    The celebrations were held at Bourn Hall fertility clinic in Cambridgeshire - set up by the fertility pioneers Patrick Steptoe and Robert Edwards - the team responsible for Louise's birth.
    Families of 30 children - one from each year since 1978 - gathered to mark the event.
    Louise's birth was one of the most remarkable medical breakthroughs of the 20th Century, and not surprisingly it generated worldwide media interest.
    Media star
    Louise says as a child in Bristol, she got used to all the media attention.
    Louise Brown now has a son of her own
    She was recognised in the street and got used to some strange questions.
    She said: "When I was growing up they would ask things like how do you fit in a test tube and things like that!"
    These days she rarely thinks about her iconic status as the first of more than three million IVF babies born worldwide.
    "It's quite scary to think I'm the first of them all, but it's also a nice feeling that perhaps if I hadn't been born then all those people wouldn't be here, and IVF has helped so many couples."
    Louise is now a mother herself, to 18 month old Cameron, although he was conceived naturally.
    Patrick Steptoe died in 1988 but Professor Edwards joined the celebrations and helped Louise cut the cake.
    Professor Edwards remembers how, once the news of the pregnancy leaked out, Louise's mother had to go into hiding.
    "We were concerned that she would lose the baby, the fetus, because the press were chasing Mrs Brown all over Bristol where she lived.
    "So secretly Patrick Steptoe hid the mother in his car and drove her to his mother's house in Lincoln - the press didn't know where she was."
    Professor Edwards was worried by the media interest
    Louise's mother said that once she was in Oldham hospital reporters tried a variety of methods to sneak into her room from a bomb hoax to posing as cleaners.
    Once Louise was born it made front-page headlines all over the world.
    Mrs Brown went on to have another daughter by IVF and is delighted that Steptoe and Edwards helped her.
    "I'm just so grateful that I'm a mum at all because without IVF I never would have been and I wouldn't have my grandchildren."
    Routine
    Since Louise Brown's birth IVF has become a routine procedure.
    More than 30,000 women a year in Britain now undergo IVF and eleven thousand babies annually are born.
    IVF was a British breakthrough, but the majority of treatment in the UK is still paid for privately and costs couples between £4,000 and £8,000 a time.
    Professor Edwards is saddened that IVF is not more widely available on the NHS.
    "Every couple should be allowed to have three babies on the health service because this is the greatest gift that you can give any man or woman."
  • Wkipedia
    In vitro fertilisation (IVF) is a process by which egg cells are fertilised by sperm outside the womb, in vitro. IVF is a major treatment in infertility when other methods of assisted reproductive technology have failed. The process involves hormonally controlling the ovulatory process, removing ova (eggs) from the woman's ovaries and letting sperm fertilise them in a fluid medium. The fertilised egg (zygote) is then transferred to the patient's uterus with the intent to establish a successful pregnancy. The first successful birth of a "test tube baby", Louise Brown, occurred in 1978. Prior to that, there was a transient biochemical pregnancy reported by Australian researchers in 1973 and an ectopic pregnancy reported by Steptoe and Edwards in 1976.
    Oocyte with surrounding granulosa cells
    "Naked" Egg
    The term in vitro, from the [Latin] root meaning within the glass, is used, because early biological experiments involving cultivation of tissues outside the living organism from which they came, were carried out in glass containers such as beakers, test tubes, or petri dishes. Today, the term in vitro is used to refer to any biological procedure that is performed outside the organism it would normally be occurring in, to distinguish it from an in vivo procedure, where the tissue remains inside the living organism within which it is normally found. A colloquial term for babies conceived as the result of IVF, test tube babies, refers to the tube-shaped containers of glass or plastic resin, called test tubes, that are commonly used in chemistry labs and biology labs. However, in vitro fertilisation is usually performed in the shallower containers called Petri dishes. (Petri-dishes may also be made of plastic resins.) However, the IVF method of Autologous Endometrial Coculture is actually performed on organic material, but is yet called in vitro. This is used when parents are having infertility problems or they want to have multiple births.
    Contents
    [hide]
    1 Indications
    2 Method
    2.1 Ovarian stimulation
    2.2 Egg retrieval
    2.3 Fertilisation
    2.4 Culture and selection
    2.5 Embryo transfer
    3 Pregnancy rates
    3.1 Effect of stress
    3.2 Live birth rate
    4 Complications
    4.1 Birth defects
    5 Preimplantation genetic diagnosis (PGD)
    6 Cryopreservation
    6.1 Oocyte cryopreservation
    7 Leftover embryos or eggs
    8 Acupuncture
    8.1 Acupuncture mechanisms
    8.2 Electro-acupuncture in oocyte retrieval for IVF
    9 History
    10 Ethics
    10.1 Issues
    10.2 Pregnancy past menopause
    10.3 Same-sex couples, single and unmarried parents
    10.4 Religious objections
    11 Availability and utilisation
    12 See also
    13 References
    14 Further reading
    15 External links
    [edit] Indications
    IVF may be used to overcome female infertility in the woman due to problems of the fallopian tube, making fertilisation in vivo difficult. It may also assist in male infertility, where there is defect sperm quality, and in such cases intracytoplasmic sperm injection (ICSI) may be used, where a sperm cell is injected directly into the egg cell. This is used when sperm have difficulty penetrating the egg, and in these cases the partner's or a donor's sperm may be used. ICSI is also used when sperm numbers are very low. ICSI results in success rates equal to those of IVF fertilisation.
    For IVF to be successful it may be easier to say that it requires healthy ova, sperm that can fertilise, and a uterus that can maintain a pregnancy. Due to the costs of the procedure, IVF is generally attempted only after less expensive options have failed.
    This also avails for egg donation or surrogacy where the woman providing the egg isn't the same who will carry the pregnancy to term. This means that IVF can be used for females who have already gone through menopause. The donated oocyte can be fertilised in a crucible. If the fertilisation is successful, the zygote will be transferred into the uterus, within which it will develop into an embryo.
    IVF can also be combined with preimplantation genetic diagnosis (PGD) to rule out presence of genetic disorders. A similar but more general test has been developed called Preimplantation Genetic Haplotyping (PGH).
    [edit] Method
    [edit] Ovarian stimulation
    Main article: Ovarian stimulation
    Treatment cycles are typically started on the third day of menstruation and consist of a regimen of fertility medications to stimulate the development of multiple follicles of the ovaries. In most patients injectable gonadotropins (usually FSH analogues) are used under close monitoring. Such monitoring frequently checks the estradiol level and, by means of gynecologic ultrasonography, follicular growth. Typically approximately 10 days of injections will be necessary. Spontaneous ovulation during the cycle is typically prevented by the use of GnRH agonists that are started prior or at the time of stimulation or GnRH antagonists that are used just during the last days of stimulation; both agents block the natural surge of luteinising hormone (LH) and allow the physician to initiate the ovulation process by using medication, usually injectable human chorionic gonadotropins.
    [edit] Egg retrieval
    Main article: Transvaginal oocyte retrieval
    When follicular maturation is judged to be adequate, human chorionic gonadotropin (hCG) is given. This agent, which acts as an analogue of luteinising hormone, would cause ovulation about 42 hours after injection, but a retrieval procedure takes place just prior to that, in order to recover the egg cells from the ovary. The eggs are retrieved from the patient using a transvaginal technique involving an ultrasound-guided needle piercing the vaginal wall to reach the ovaries. Through this needle follicles can be aspirated, and the follicular fluid is handed to the IVF laboratory to identify ova. It is common to remove between ten and thirty eggs. The retrieval procedure takes about 20 minutes and is usually done under conscious sedation or general anaesthesia.
    [edit] Fertilisation
    In the laboratory, the identified eggs are stripped of surrounding cells and prepared for fertilisation. In the meantime, semen is prepared for fertilisation by removing inactive cells and seminal fluid in a process called sperm washing. If semen is being provided by a sperm donor, it will usually have been prepared for treatment before being frozen and quarantined, and it will be thawed ready for use. The sperm and the egg are incubated together at a ratio of about 75,000:1 in the culture media for about 18 hours. In most cases, the egg will be fertilised by that time and the fertilised egg will show two pronuclei. In certain situations, such as low sperm count or motility, a single sperm may be injected directly into the egg using intracytoplasmic sperm injection (ICSI). The fertilised egg is passed to a special growth medium and left for about 48 hours until the egg consists of six to eight cells.
    In gamete intrafallopian transfer, eggs are removed from the woman and placed in one of the fallopian tubes, along with the man's sperm. This allows fertilisation to take place inside the woman's body. Therefore, this variation is actually an in vivo fertilisation, not an in vitro fertilisation.
    [edit] Culture and selection
    Laboratories have developed grading methods to judge oocyte and embryo quality. Typically, embryos that have reached the 6–8 cell stage are transferred three days after retrieval. In many Canadian, American and Australian programmes[citation needed], however, embryos are placed into an extended culture system with a transfer done at the blastocyst stage at around five days after retrieval, especially if many good-quality embryos are still available on day 3. Blastocyst stage transfers have been shown to result in higher pregnancy rates.[1] In Europe, transfers after 2 days are common. Preimplantation Genetic Diagnosis (PGD) procedures may be performed prior to transfer.[2]
    Culture of embryos can either be performed in an artificial culture medium or in an autologous endometrial coculture (on top of a layer of cells from the woman's own uterine lining). With artificial culture medium, there can either be the same culture medium throughout the period, or a sequential system can be used, in which the embryo is sequentially placed in different media. For example, when culturing to the blastocyst stage, one medium may be used for culture to day 3, and a second medium is used for culture thereafter.[3] Single or sequential medium are equally effective for the culture of human embryos to the blastocyst stage. [4]
    [edit] Embryo transfer
    Main article: Embryo transfer
    Embryos are graded by the embryologist based on the number of cells, evenness of growth and degree of fragmentation. The number to be transferred depends on the number available, the age of the woman and other health and diagnostic factors. In countries such as Canada, the UK, Australia and New Zealand, a maximum of two embryos are transferred except in unusual circumstances. In the UK and according to HFEA regulations, a woman over 40 may have up to three embryos transferred, whereas in the USA, younger women may have many embryos transferred based on individual fertility diagnosis. Most clinics and country regulatory bodies seek to minimise the risk of pregnancies carrying multiples. The embryos judged to be the "best" are transferred to the patient's uterus through a thin, plastic catheter, which goes through her vagina and cervix. Several embryos may be passed into the uterus to improve chances of implantation and pregnancy.
    [edit] Pregnancy rates
    Pregnancy rate is the success rate for pregnancy. For IVF, it is the percentage of all attempts that lead to pregnancy, which generally refers to treatment cycles where eggs are retrieved and fertilised in vitro. Statistics referring to "pregnancy" may refer to just a positive pregnancy test, and not necessarily "viable pregnancy" which implies the detection of a fetal heart beat. Pregnancies that are delivered with a viable baby are called live birth rate. Increasingly a distinction is also made between singleton and multiple pregnancies as multiple pregnancies, specifically more than twins, should be avoided because of the associated maternal and fetal risks.
    With enhanced technology, the pregnancy rates are substantially better today than a couple of years ago. In 2006, Canadian clinics reported an average pregnancy rate of 35%.[5] A French study estimated that 66% of patients starting IVF treatment finally succeed in having a child (40% during the IVF treatment at the center and 26% after IVF discontinuation). Achievement of having a child after IVF discontinuation was mainly due to adoption (46%) or spontaneous pregnancy (42%).[6]
    [edit] Effect of stress
    In a 2005 Swedish study,[7] 166 women were monitored starting one month before their IVF cycles, and the results showed no significant correlation between psychological stress and IVF outcome. The study concluded with the recommendation to clinics that it might be possible to reduce the stress experienced by IVF patients during the treatment procedure by informing them of those findings. While psychological stress experienced during a cycle might not influence an IVF outcome, it is possible that the experience of IVF can result in stress that leads to depression. The financial consequences alone of IVF can influence anxiety and become overwhelming. However, for many couples, the alternative is infertility, and the experience of infertility itself can also cause extreme stress and depression.
    [edit] Live birth rate
    Live birth rate is the percentage of all IVF cycles that lead to live birth, and is the pregnancy rate adjusted for miscarriage and stillbirth. These percentages are for successful pregnancies, regardless of the number of children born, as twins and larger multiple-order births are more common in IVF cycles.
    In 2006, Canadian clinics reported a live birth rate of 27%.[5] Birth rates in younger patients were slightly lower, with a success rate of 35.3% for those 21 and younger, the youngest group evaluated. Success rates for older patients were also lower and decrease with age, with 37-year-olds at 27.4% and no live births for those older than 48, the oldest group evaluated. [8] Some clinics exceeded these rates, but it is impossible to determine if that is due to superior technique or patient selection, because it is possible to artificially increase success rates by refusing to accept the most difficult patients or by steering them into oocyte donation cycles (which are compiled separately).
    The Society for Assisted Reproductive Technology (SART) summarized 2008 success rates for US clinics for fresh embryo cycles that did not involve donor eggs gave live birth rates by the age of the prospective mother, with a peak at 41.3% per cycle started and 47.3% per embryo transfer for patients under 35 years of age.
    IVF attempts in multiple cycles result in increased cumulative live birth rates. Depending on the demographic group, one study reported 45% to 53% for three attempts, and 51% to 71% for six attempts.[9]
    [edit] Complications
    The major complication of IVF is the risk of multiple births. This is directly related to the practice of transferring multiple embryos at embryo transfer. Multiple births are related to increased risk of pregnancy loss, obstetrical complications, prematurity, and neonatal morbidity with the potential for long term damage. Strict limits on the number of embryos that may be transferred have been enacted in some countries (e.g. England) to reduce the risk of high-order multiples (triplets or more), but are not universally followed or accepted. Spontaneous splitting of embryos in the womb after transfer can occur, but this is rare and would lead to identical twins. A double blind, randomised study followed IVF pregnancies that resulted in 73 infants (33 boys and 40 girls) and reported that 8.7% of singleton infants and 54.2% of twins had a birth weight of < 2500 g.[10] However recent evidence suggest that singleton offspring after IVF is at higher risk for lower birth weight for unknown reasons.
    Another risk of ovarian stimulation is the development of ovarian hyperstimulation syndrome, particularly if hCG is used to "trigger ovulation".
    If the underlying infertility is related to abnormalities in spermatogenesis, it is plausible, but too early to examine that male offspring is at higher risk for sperm abnormalities.
    Behavior and socioemotional functioning of children conceived by IVF is normal overall, according to studies on 9–18-year-old IVF children.[11]
    A negative pregnancy test after IVF is associated with an increased risk for depression in women, but not with any increased risk of developing anxiety disorders.[12] Pregnancy test results do not seem to be a risk factor for depression or anxiety among men.[12]
    [edit] Birth defects
    The issue of birth defects has been a controversial topic in IVF. Many studies do not show a significant increase after use of IVF, and some studies suggest higher rates for ICSI, whereas others do not support this finding.[13] In 2008, an analysis of the data of the National Birth Defects Study in the US found that certain birth defects were significantly more common in infants conceived with IVF, notably septal heart defects, cleft lip with or without cleft palate, esophageal atresia, and anorectal atresia; the mechanism of causality is unclear.[14]
    Japan's government prohibited the use of in vitro fertilisation procedures for couples in which both partners are infected with HIV. Despite the fact that the ethics committees previously allowed the Ogikubo Hospital, located in Tokyo, to use in vitro fertilisation for couples with HIV, the Health, Labour and Welfare Ministry of Japan decided to block the practice. Hideji Hanabusa, the vice president of the Ogikubo Hospital, states that together with his colleagues, he managed to develop a method through which scientists are able to remove the AIDS virus from sperm.[15]
    [edit] Preimplantation genetic diagnosis (PGD)
    Main article: Preimplantation genetic diagnosis
    Preimplantation genetic diagnosis used in conjunction with IVF treatments appeared in the early 1990s, and since then hundreds of normal, healthy babies have been born using this advanced reproductive technology. PGD technology improves the likelihood of a successful pregnancy and birth for two distinctly different groups of patients. Couples with infertility related to recurrent miscarriage or unsuccessful IVF cycles and couples who are at risk for passing on inherited genetic disease to their offspring.
    Patients who also can benefit from PGD include:
    Couples who have a family history of inherited disease
    Couples who want to use gender selection to prevent a gender-linked disease
    Women who have had repeated failures with IVF
    Women with a history of unexplained miscarriage
    Women who are more than 39 years old
    PGD screens for chromosomal abnormalities. It screens individual cells from a pre-embryo during the IVF process. Before the transfer of a pre-embryo back to a woman's uterus, one or two cells are removed from the pre-embryos. These cells are then evaluated for normalcy. Typically within one to two days, following completion of the evaluation, only the normal pre-embryos are transferred back to the woman's uterus. In addition, PGD can reduce the risk of multiple pregnancies because fewer embryos are needed for implantation.[16]
    [edit] Cryopreservation
    Main article: Cryopreservation
    The first pregnancy derived from a frozen human embryo was reported by Alan Trounson & Linda Mohr in 1983 (although the fetus aborted spontaneously at about 20 weeks of gestation); the first term pregnancies derived from frozen human frozen freezing process was born in 1984. Since then and up to 2008 it is estimated that between 350,000 and half a million IVF babies have been born from embryos controlled rate frozen and then stored in liquid nitrogen; additionally a few hundred births have been born from vitrified oocytes but firm figures are hard to come by.
    On the safety of embryo cryopreservation, a 2008 study reported at the European Society of Human Reproduction and Embryology discovered that children born from frozen embryos did “better and had a higher birth weight” than children born from a fresh transfer. The study was conducted out of Copenhagen and evaluated babies born during the years 1995–2006. 1267 children born after Frozen Embryo Replacement (FER), via controlled-rate freezers and storage in liquid nitrogen, were studied and categorised into three groups. 878 of them were born using frozen embryos that were created using standard in vitro fertilisation in which the sperm were placed into a dish close to the egg but had to penetrate the egg on their own. 310 children were born with frozen embryos created using ICSI in which a single sperm was injected into a single egg, and 79 were born where the method of creation of the embryos was not known.
    17,857 babies born after a normal IVF/ICSI with fresh embryos were also studied and used as a control group or reference group. Data on all of the children’s outcomes were taken regarding birth defects, birth weights, and length of pregnancy. The results of the study showed that the children who came from frozen embryos had higher birth weights, gave longer pregnancies and produced fewer “pre-term” births. There was no difference in the rate of birth defects whether the children came from frozen embryos or fresh embryos. In the FER group, the birth defect rate was 7.7% compared to the fresh transfer group which was slightly higher at 8.8%. The scientists also found that the risk for multiple pregnancies was increased in the fresh embryo transfers.
    Around 11.7% of the ICSI and 14.2% of the IVF frozen cases were multiple pregnancies. In the case of fresh embryos, 24.8% of the ICSI and 27.3% of the IVF were multiple pregnancies. It should also be noted that maternal age was significantly higher in the FER group. This is significant since based on age one would have expected a higher rate of problems and birth defects. The study adds to the body of knowledge suggesting that traditional embryo freezing is a safe procedure. It was unclear however why the frozen embryo children did better than their fresh embryo counterparts.
    If multiple embryos are generated, patients may choose to freeze embryos that are not transferred. Those embryos are slow frozen and then placed in liquid nitrogen and can be preserved for a long time. There are currently 500,000 frozen embryos in the United States.[17] The advantage is that patients who fail to conceive may become pregnant using such embryos without having to go through a full IVF cycle. Or, if pregnancy occurred, they could return later for another pregnancy. Spare embryos resulting from fertility treatments may be donated to another woman or couple, and embryos may be created, frozen and stored specifically for transfer and donation by using donor eggs and sperm.
    [edit] Oocyte cryopreservation
    Cryopreservation of unfertilised mature oocytes has been successfully accomplished, e.g. in women who are likely to lose their ovarian reserve due to undergoing chemotherapy.[18]
    [edit] Leftover embryos or eggs
    Further information: Embryo donation and Egg donor
    There may be leftover embryos or eggs from IVF procedures if the woman for whom they were originally created has successfully carried one or more pregnancies to term. With the woman's or couple's permission, these may be donated to help other women or couples as a means of third party reproduction.
    In embryo donation, these extra embryos are given to other couples or women for transfer with the goal of producing a successful pregnancy. The resulting child is considered the child of the woman who carries it and gives birth, and not the child of the donor, the same as occurs with egg donation or sperm donation.
    Typically, genetic parents donate the eggs to a fertility clinic or embryo bank where they are cryogenically preserved until a carrier is found for them. Typically the process of matching the embryo(s) with the prospective parents is conducted by the agency itself, at which time the clinic transfers ownership of the embryos to the prospective parents. [19]
    In the United States, women seeking to be an embryo recipient undergo infectious disease screening required by the U.S. Food and Drug Administration (FDA), and reproductive tests to determine the best placement location and cycle timing before the actual Embryo Transfer occurs. The amount of screening the embryo has already undergone is largely dependent on the genetic parents' own IVF clinic and process. The embryo recipient may elect to have her own embryologist conduct further testing.
    Alternatives to donating unused embryos are discarding them (or having them implanted at a time where pregnancy is very unlikely[20]), keeping them frozen indefinitely, donating them for use in embryonic stem cell research.
    [edit] Acupuncture
    An increasing number of fertility specialists and centers offer acupuncture as a part of their IVF protocol. Limited but supportive evidence from clinical trials and case series suggests that acupuncture may improve the success rate of IVF and the quality of life of patients undergoing IVF and that it is a safe adjunct therapy.[21] A systematic review and meta-analysis published in the British Medical Journal found that complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (where the expected number of patients needed to be treated to produce 1 additional pregnancy was 10), ongoing pregnancy (NNT 9), and live birth (NNT 9).[22]
    [edit] Acupuncture mechanisms
    Four mechanisms by which it has been suggested that acupuncture may improve IVF outcomes are[21]
    Neuroendocrinological modulations
    Increased blood flow to uterus and ovaries
    Modulation in cytokines
    Reduction of stress, anxiety, and depression
    [edit] Electro-acupuncture in oocyte retrieval for IVF
    Electro-acupuncture has been found to be a good alternative to conventional medical analgesia, it results in shorter hospitalisation times and lower costs.[23]
    [edit] History
    John Rock was the first to extract an intact fertilised egg.[24] The first pregnancy achieved through in vitro human fertilisation of a human oocyte was reported in The Lancet from the Monash team [25] in 1973, although it lasted only a few days and would today be called a biochemical pregnancy. In 1977, Patrick Steptoe and Robert Edwards successfully carried out a pioneering conception which resulted in the birth of the world's first baby to be conceived by IVF, Louise Brown on 25 July 1978, in Oldham General Hospital, Greater Manchester, UK [26][27] followed by Courtney Cross on 16 October 1978 and Alastair MacDonald on 14 January 1979. This was then followed by the birth of Candice Reed in Melbourne in 1980. It was the subsequent use of stimulated cycles with clomiphene citrate and the use of human chorionic gonadotrophin (hCG) to control and time oocyte maturation, thus controlling the time of collection, that converted IVF from a research tool to a clinical treatment.
    This was followed by a total of 14 pregnancies resulting in nine births in 1981 with the Monash university team. The Jones team[28] at the Eastern Virginia Medical School in Norfolk, Virginia, further improved stimulated cycles by incorporating the use of a follicle-stimulating hormone (uHMG). This then became known as controlled ovarian hyperstimulation (COH). Another step forward was the use of gonadotrophin-releasing hormone agonists (GnRHA), thus decreasing the need for monitoring by preventing premature ovulation, and more recently gonadotrophin-releasing hormone antagonists (GnRH Ant), which have a similar function. The additional use of the oral contraceptive pill has allowed the scheduling of IVF cycles, which has made the treatment far more convenient for both staff and patients.
    The ability to freeze and subsequently thaw and transfer embryos has significantly improved the feasibility of IVF use.[29] The other very significant milestone in IVF was the development of the intracytoplasmic sperm injection (ICSI) of single sperms by André van Steirteghem in Brussels, 1992. This has enabled men with minimal sperm production to achieve pregnancies. ICSI is sometimes used in conjunction with sperm recovery, using a testicular fine needle or open testicular biopsy. Using this method, some men with Klinefelter's syndrome, and so would be otherwise infertile, have occasionally been able to achieve pregnancy.[29][30] Thus, IVF has become the final solution for most fertility problems, moving from tubal disease to male factor, idiopathic subfertility, endometriosis, advanced maternal age, and anovulation not responding to ovulation induction.
    Carl Wood was dubbed "the father of IVF (in vitro fertilisation)" for having pioneered the use of frozen embryos.[31]
    In the US, ART cycles started in 2006 resulted in 41,343 births (54,656 infants), which is slightly more than 1% of total US births.[32]
    [edit] Ethics
    [edit] Issues
    See also: Beginning of pregnancy controversy
    In a few cases, laboratory mix-ups (misidentified gametes, transfer of wrong embryos) have occurred, leading to legal action against the IVF provider and complex paternity suits. An example is the case of a woman in California who received the embryo of another couple and was notified of this mistake after the birth of her son.[33] This has led to many authorities and individual clinics implementing procedures to minimise the risk of such mix-ups. The HFEA, for example, requires clinics to use a double witnessing system, where the identity of specimens is checked by two people at each point at which specimens are transferred. Alternatively, technological solutions are gaining favour, to reduce the manpower cost of manual double witnessing, and to further reduce the risk of human error.[34] Technological solutions typically involve tagging individual specimen containers with uniquely numbered RFID tags which can be identified by readers connected to a computer. The computer tracks specimens throughout the process and alerts the embryologist if non-matching specimens are identified.
    Another concern is that people will screen in or out for particular traits, using preimplantation genetic diagnosis. For example, a deaf British couple, Tom and Paula Lichy, have petitioned to create a deaf baby using IVF.[35] Some medical ethicists have been very critical of this approach. Jacob Appel wrote that "intentionally culling out blind or deaf embryos might prevent considerable future suffering, while a policy that allowed deaf or blind parents to select for such traits intentionally would be far more troublesome."[36]
    [edit] Pregnancy past menopause
    Although menopause is a natural barrier to further conception, IVF has allowed women to be pregnant in their fifties and sixties. Women whose uterus has been appropriately prepared receive embryos that originated from an egg of an egg donor. Therefore, although these women do not have a genetic link with the child, they have an emotional link through pregnancy and childbirth. In many cases the genetic father of the child is the woman's partner. Even after menopause the uterus is fully capable of carrying out a pregnancy.[37]
    [edit] Same-sex couples, single and unmarried parents
    A 2009 statement from the ASRM found no persuasive evidence that children are harmed or disadvantaged solely by being raised by single parents, unmarried parents, or gay and lesbian parents. It did not support restricting access to assisted reproductive technologies on the basis of a prospective parent's marital status or sexual orientation.[38]
    Ethical concerns include reproductive rights, the welfare of offspring, nondiscrimination against unmarried individuals, and gays and lesbians, and professional autonomy.[38]
    A recent controversy in California focused on the question of whether physicians opposed to same-sex relationships should be required to perform IVF for a lesbian couple. Guadalupe T. Benitez, a medical assistant from San Diego, sued doctors Christine Brody and Douglas Fenton of the North Coast Women's Care Medical Group after Brody told her that she had "religious-based objections to treating homosexuals to help them conceive children by artificial insemination," and Fenton refused to authorise a refill of her prescription for the fertility drug Clomid on the same grounds.[39][40] The case, North Coast Women's Care Medical Group v. Superior Court, was decided in favor of Benitez on August 19, 2008.[41]
    [edit] Religious objections
    The Roman Catholic Church opposes all kinds of in vitro fertilisation because, as with contraception, it separates the procreative purpose of the marriage act from its unitive purpose:
    This particular doctrine [of "observing the natural law"], often expounded by the magisterium of the Church, is based on the inseparable connection, established by God, which man on his own initiative may not break, between the unitive significance and the procreative significance which are both inherent to the marriage act. The reason is that the fundamental nature of the marriage act, while uniting husband and wife in the closest intimacy, also renders them capable of generating new life—and this as a result of laws written into the actual nature of man and of woman. And if each of these essential qualities, the unitive and the procreative, is preserved, the use of marriage fully retains its sense of true mutual love and its ordination to the supreme responsibility of parenthood to which man is called. We believe that our contemporaries are particularly capable of seeing that this teaching is in harmony with human reason.[42]
    According to the Catechism of the Catholic Church,
    Techniques involving only the married couple (homologous artificial insemination and fertilization) [...] dissociate the sexual act from the procreative act. The act which brings the child into existence is no longer an act by which two persons give themselves to one another, but one that "entrusts the life and identity of the embryo into the power of doctors and biologists and establishes the domination of technology over the origin and destiny of the human person. Such a relationship of domination is in itself contrary to the dignity and equality that must be common to parents and children."[43]
    The Catholic Church advocates that infertility is a call from God to adopt children because
    The Gospel shows that physical sterility is not an absolute evil. Spouses who still suffer from infertility after exhausting legitimate medical procedures should unite themselves with the Lord's Cross, the source of all spiritual fecundity. They can give expression to their generosity by adopting abandoned children or performing demanding services for others.[43]
    Also, embryos are sometimes discarded in the in vitro fertilisation process. Catholics and many people of other faiths see embryos as human lives with the same rights as all others and therefore view the destruction of embryos as the loss of human life.
    Gamete Intrafallopian Transfer (GIFT) is not technically in vitro fertilisation because with GIFT, fertilisation takes place inside the body, not on a Petri dish. The Catholic Church nevertheless is concerned with it because "Some theologians consider this to be a replacement of the marital act, and therefore immoral."[44]
    [edit] Availability and utilisation
    In the USA, overall availability of IVF in 2005 was 2.5 IVF physicians per 100,000 population, and utilisation was 236 IVF cycles per 100,000.[45] Utilisation highly increases with availability and IVF insurance coverage, and to a significant extent also with percentage of single persons and median income.[45]
    The cost of IVF rather reflects the costliness of the underlying healthcare system than the regulatory or funding environment,[46] and ranges, on average for a standard IVF cycle and in 2006 United States dollars, between $12,500 in the United States to $4,000 in Japan. [46] In Ireland, IVF costs around €4,000, with fertility drugs, if required, costing up to €3,000.[47] The cost per live birth is highest in the United States ($41,000[46]) and United Kingdom ($40,000[46]) and lowest in Scandinavia and Japan (both around $24,500[46]).
    Many fertility clinics in the United States limit the upper age at which women are eligible for IVF to 50 or 55 years.[48] These cut-offs make it difficult for women older than fifty-five to utilise the procedure.[48]
    In Australia, the average age of women undergoing ART treatment is 35.5 years among those using their own eggs (one in four being 40 or older) and 40.5 years among those using donated eggs.
  • Beneficence
  • wikipedia
  • Christopher Reeve 1952-2004 Quadriplegic 1995 lobbied for HESC

    Human Embryonic Stem Cells
    Stem cells generally are self-renewing primitive cells that can develop into functional, differentiated cells. Human embryonic stem cells (hESCs), which are derived from very early stage embryos called blastocysts, are unique because:
    they are pluripotent, which means they can develop into all cells and tissues in the body, and
    they self-renew indefinitely in the undifferentiated state because they express high levels of telomerase.
    The ability of hESCs to divide indefinitely in the undifferentiated state without losing pluripotency is a unique characteristic that distinguishes them from all other stem cells discovered to date in humans. We have demonstrated that hESCs express telomerase continuously, a characteristic of immortal cells. Other stem cells such as blood or gut stem cells express telomerase at very low levels or only periodically; they therefore age, limiting their use in research or therapeutic applications. hESCs can be expanded in culture indefinitely and hence can be banked for scaled product manufacture.
    We intend to use human embryonic stem cell technology to enable the development of transplantation therapies by providing standard starting material for the manufacture of therapeutic cells and facilitate pharmaceutical research and development practices by providing cells for disease models and screening.
    We have developed proprietary methods to grow, maintain, and scale the culture of undifferentiated hESCs that use feeder cell-free and serum-free media with chemically defined components. Moreover, we have developed scalable processes to differentiate these cells into therapeutically relevant cells. We have developed cryopreserved formulations of hESC-derived cells to enable our business model of delivering "on demand" cells for therapeutic use.
    Under our collaboration with Corning Life Sciences, a division of Corning Incorporated, we are working together to develop synthetic growth surfaces to replace the biological surface coatings that are widely used today to grow hESCs. Together our teams have developed a synthetic peptide surface that can be manufactured into multiple culture vessel formats and directly supports the growth and differentiation of hESCs. Data on hESC culture and differentiation were presented by Corning at the 2009 World Stem Cell Summit held in September.
    Geron's hESCs were derived by our collaborators from donated in vitro fertilized blastocysts (very early-stage embryos). We currently have nine hESC lines; most of our development work so far has focused on three of those lines.
    Related Links
    Stem Cell Information at National Institutes of Health
    International Society for Stem Cell Research (ISSCR)
    Following is a list of hESC-derived product candidates that we are developing. Click on the links below for more information about a specific product.
    Product Product Description Application Development Stage GRNOPC1 Oligodendrocyte Progenitor Cells Spinal Cord Injury Phase I Clinical Trial* GRNCM1 Cardiomyocytes Heart Disease Preclinical GRNIC1 Islets Type 1 Diabetes Research GRNCHND1 Chondrocytes Osteoarthritis Research Hepatocytes ADME Drug Screening Research GRNVAC2 Mature Dendritic Cells Cancer Immunotherapy Product Research Immature Dendritic Cells Immune Rejection Research Osteoblasts Osteoporosis Research *In January 2009, we received clearance from the FDA to begin a clinical trial of GRNOPC1. The trial is currently on clinical hold by the FDA.
    Since clearance of the IND, Geron has been performing a series of preclinical studies to expand the clinical program (preclinical expansion studies) for spinal cord injury beyond patients with complete thoracic injuries. Our goal is to test the safety and utility of GRNOPC1 in patients with complete and incomplete (less severe) injuries in both thoracic and cervical regions.
    In one of the preclinical expansion studies, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1, including the IND-enabling studies. We notified the FDA of the findings from this animal study and the trial was put on clinical hold in August 2009. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, we developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA.
    Following discussions with the FDA, we have agreed to complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays. As part of the ongoing plan to advance clinical development to cervical patients, we had already initiated that preclinical study in an animal model of cervical injury. In our discussions, the FDA has advised us that it concurs with our assessment that positive data from this study, once completed, can be used to support both release of the clinical hold related to our IND and expansion of the clinical trial to cervical patients.
    Click here for information on the planned clinical trial in patients with acute spinal cord injury.
    In addition to spinal cord injury, GRNOPC1 may have therapeutic utility for other central nervous system indications, such as Alzheimer's disease, stroke and multiple sclerosis. We have established two separate collaborations with academic groups to test GRNOPC1 in models of Alzheimer's disease and multiple sclerosis.
  • Autonomy
    http://stemcells.nih.gov/policy/2009guidelines.htm
    Temptation if same clinician/researcher to harvest additional eggs
  • Non-maleficence – looking at beneficence and autonomy is relatively. The harder ethical principle to consider is non-maleficence – What is it that is being harmed in the destruction of an embryo? Is it something fully human, something with the potential of becoming fully human, or . . .?
    Zygote-morula-18 weeks-near viability-newborn
    Ultrasound is 18 weeks – time around quickening
  • The primitive streak is an important concept in bioethics, where some experts (Presidential Council on Bioethics, Human Cloning, and Human Dignity) have argued that experimentation with human embryos is permissible only before the primitive streak develops, generally around the fourteenth day of existence. The development of the primitive streak is taken, by such bioethicists, to signify the creation of a unique, potential human being. Embryo unique, no longer capable of twinning. Developing symmetry.
  • St. Augustine (354-430 CE) reversed centuries of Christian teaching in Western Europe, by returning to the Aristotelian Pagan concept of "delayed ensoulment." He wrote 7 that a human soul cannot live in an unformed body. Thus, early in pregnancy, an abortion is not murder because no soul is destroyed (or, more accurately, only a vegetable or animal soul is terminated). He wrote extensively on sexual matters, teaching that the original sin of Adam and Eve are passed to each successive generation through the pleasure generated during sexual intercourse. This passed into the church's canon law. Only abortion of a more fully developed "fetus animatus" (animated fetus) was punished as murder.
    Augustine had little influence over the beliefs of Orthodox Christianity. They retained their original anti-abortion stance.
    St. Jerome (circa 340 - 420) wrote in a letter to Aglasia:
    "The seed gradually takes shape in the uterus, and it [abortion] does not count as killing until the individual elements have acquired their external appearance and their limbs" 8
    Starting in the 7th century CE, a series of penitentials were written in the West. These listed an array of sins, with the penance that a person must observe as punishment for the sin. Certain "sins" which prevented conception had particularly heavy penalties. These included:
    practicing a particularly ineffective form of birth control, coitus interruptus (withdrawal of the penis prior to ejaculation) engaging in oral sex or anal sex becoming sterile by artificial means, such as by consuming sterilizing poisons. Abortion, on the other hand, required a less serious penance. Theodore, who organized the English church, assembled a penitential about 700 CE. Oral intercourse required from 7 years to a lifetime of penance; an abortion required only 120 days.
    Pope Stephen V (served 885-891) wrote in 887 CE: "If he who destroys what is conceived in the womb by abortion is a murderer, how much more is he unable to excuse himself of murder who kills a child even one day old." "Epistle to Archbishop of Mainz."
    Pope Innocent III (circa 1161-1216):
    He wrote a letter which ruled on a case of a Carthusian monk who had arranged for his female lover to obtain an abortion. The Pope decided that the monk was not guilty of homicide if the fetus was not "animated." Early in the 13th century he stated that the soul enters the body of the fetus at the time of "quickening" - when the woman first feels movement of the fetus. After ensoulment, abortion was equated with murder; before that time, it was a less serious sin, because it terminated only potential human life, not human life. St. Thomas Aquinas (1225-1274) also considered only the abortion of an "animated" fetus as murder.
    Pope Sixtus V (1471-1484) issued a Papal bull "Effraenatam" in 1588 which threatened those who carried out abortions at any stage of gestation with excommunication and the death penalty.
    Pope Gregory XIV (1535-1591) revoked the Papal bull shortly after taking office in 1591. He reinstated the "quickening" test, which he determined happened 116 days into pregnancy (16½ weeks).
    17th TO 19th Century CE (Abortion becomes murder again):
    In the 17th century, the concept of "simultaneous animation" gained acceptance within the medical and church communities in Western Europe. 9 This is the belief that an embryo acquires a soul at conception, not at 40, 80. or 116 days into gestation as the church was teaching.
    Hieronymus Florentinius, a Franciscan monk, asserted In 1658 that all embryos or fetuses, regardless of their gestational age, which were in danger of death must be baptized. However, his opinion did not change the status of abortion as seen by the church.
    Pope Pius IX (1792-1878) reversed the stance of the Roman Catholic church once more. He dropped the distinction between the "fetus animatus" and "fetus inanimatus" in 1869.
    Leo XIII (1878-1903):
    He issued a decree in 1884 that prohibited craniotomies. This is an unusual form of abortion used late in pregnancy and is occasionally needed to save the life of the pregnant woman. He issued a second degree in 1886 that prohibited all procedures that directly killed the fetus, even if done to save the woman's life. The tolerant approach to abortion which had prevailed in the Roman Catholic Church for previous centuries ended. The church required excommunication for abortions at any stage of pregnancy. This position has continued to the present time. Canon law was revised in 1917 and 1983 and to refer simply to "the fetus."
    Related essays in this web site:
    Abortion: all aspects; all points of view Evolution of Roman Catholic positions on abortion: Overview Current Roman Catholic teaching Exceptions to the Roman Catholic ban on abortion Jewish beliefs about abortion
    Sponsored links:
    References used:
    Aristotle "History of Animals, Book VII, Chapter 3, 583b. Philo of Alexandria, "On the Individual Laws", 3, 20, 110. Uta Ranke-Heinemann, "Eunuchs for the Kingdom of Heaven: Women, Sexuality and the Catholic Church", Doubleday, New York NY, (1990). Pages 68-70 Tertullian, "Apology" (9:7-8) Minucius Felix, "Octavious (30, 2) Ambrose, "Hexaemeron", (5, 18, 58) St. Augustine, "On Exodus", (21, 80) St Jerome, "Epistle" (121, 4) Uta Ranke-Heinemann, op cit., Page 298-311 Rosemary Stasek, "A Brief History of Abortion in the Catholic Church", 1991 speech. Available at: http://www.stasek.com/ "What Does the Bible Say about Abortion?," at: http://www.infidels.org/ "The Apostolic Constitutions," Priests for Life, at: http://www.priestsforlife.org/
     
    Uta Ranke-Heinemann, "Eunuchs for the Kingdom of Heaven: Women, Sexuality and the Catholic Church", Doubleday, New York NY, (1990). Pages 298-311 John Cardinal O'Connor, "Abortion: Questions and Answers," (1990), Page 23. Patrick Reardon, "Abortion & the mother's life," Touchstone Magazine. Online at:  http://www.catholic.net/ "Touchstone: A journal of mere Christianity" has a home page at http://www.touchstonemag.com/ "Abortion," New Advent. Translated from the Catholic Encyclopedia, Volume 1 (1907). Online at: http://www.newadvent.org/ Pope Paul VI, "Humanae Vitae. Encyclical of Pope Paul VI on the regulation of birth," 1968-JUL-25, at: http://www.vatican.va/ "Apostolic Consitutions - Didache Book VII," at: http://www.piney.com/ "Excerpt from … The Teaching of the Twelve Apostles; The Didache; (1st Century AD)," Priests for Life, at: http://www.priestsforlife.org/  
     
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    Ethics Advisory Board, NAS, National Bioethics Advisory Commission as sources of respect but not fully human
    From Wikipedia, the free encyclopedia
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    In Christian theology, ensoulment is the creation of a soul within a human being or, to those who believe in pre-existence of the soul, the moment at which the soul is inserted into the body. The exact gestational age at which ensoulment is believed to happen is debatable.
    Some theologians have believed that souls are newly created within a developing fetus, while others believe that souls were created before time and are added to the fetus as it develops.
    Common views include ensoulment happening at the moment of conception, at the formation of the nervous system and brain, at the first brain activity, at the time of quickening, and when the fetus is able to survive independently of the uterus (viability).[1] Others place the time of ensoulment at the moment of birth, and others at the moment of first breath.[2]
    Contents
    [hide]
    1 Roman Catholic Church
    2 Islam
    3 Judaism
    4 References
    5 External links
    [edit] Roman Catholic Church
    Mediaeval declarations by Popes and theologians on ensoulment were based on the then prevailing scientific theory, which, as stated by Aristotle, held that individual human life began only after 40 days for males or 90 for females, the stage at which, it was held, movement is first felt within the womb.[3][4]
    Aristotle's view of successive life principles ("souls") in a developing human embryo - first a vegetative and then a sensitive or animal soul, and finally an intellective or human soul, with the higher levels able to carry out the functions also of the lower levels[5] - was accepted by, for example, 13th-century Thomas Aquinas , who wrote:
    "Therefore it must be said that the intellective soul is created by God at the completion of man's coming-into-being. This soul is at one and the same time both a sensitive and nutritive life-principle, the preceding forms having been dissolved"[6]
    From this view followed a belief that causing the death of a yet unensouled embryo was not homicide. Aquinas himself distinguished in this context between an "animated" fetus, and one that was not yet animated : "He that strikes a woman with child does something unlawful: wherefore if there results the death either of the woman or of the animated fetus, he will not be excused from homicide, especially seeing that death is the natural result of such a blow."[7] and in the same 13th century, Innocent III stated that abortion before quickening (when the mother first feels movement of the fetus) was not murder.
    The 1312 Council of Vienne declared that the substance of the rational or intellectual soul is of itself and essentially the form of the human body,[8] It thus accepted the view of "delayed hominization", since the human embryo was not considered to have a rational or intellectual soul immediately.[9]
    Although Pope Sixtus V issued in 1588 the Bull Effraenatam which subjected those that carried out abortions at any stage of gestation with excommunication and the punishment by civil authorities applied to murderers.[10] in 1591, Gregory XIV modified this law so that the penalty did not apply until the fetus became animated.[11]
    Thus the abandonment by scientists of Aristotelian physics did not immediately bring about a similar abandoment in Church documents of the theory of delayed ensoulment. Later declarations are more severe with regard to early abortion of an embryo, though without explicitly equating early abortion with homicide.
    In 1679, Pope Innocent XI publicly condemned sixty-five propositions as "at least scandalous and in practice dangerous", including:
    34. It is lawful to procure abortion before ensoulment of the fetus lest a girl, detected as pregnant, be killed or defamed. 35. It seems probable that the fetus (as long as it is in the uterus) lacks a rational soul and begins to first have one when it is born; and consequently it must be said that no abortion is homicide.[12]
    In the 1869 Bull Apostolicae Sedis, Pius IX rescinded Gregory XIV's not-yet-animated fetus exception and re-enacted the penalty of excommunication for abortions at any stage of pregnancy.[11] Since then, canon law makes no distinction as regards excommunication between stages of pregnancy at which abortion is performed.
    In spite of the difference in ecclesiastical penalties imposed during the period when the theory of delayed ensoulment was accepted as scientific truth, abortion at any stage has always been condemned by the Church.[13] and continues to do so.[14][15] However, in its official declarations, the Catholic Church avoids taking a position on the philosophical question of the moment when a human person begins to be:
    This Congregation is aware of the current debates concerning the beginning of human life, concerning the individuality of the human being and concerning the identity of the human person. The Congregation recalls the teachings found in the Declaration on Procured Abortion: "From the time that the ovum is fertilized, a new life is begun which is neither that of the father nor of the mother; it is rather the life of a new human being with his own growth. It would never be made human if it were not human already. To this perpetual evidence ... modern genetic science brings valuable confirmation. It has demonstrated that, from the first instant, the programme is fixed as to what this living being will be: a man, this individual-man with his characteristic aspects already well determined. Right from fertilization is begun the adventure of a human life, and each of its great capacities requires time ... to find its place and to be in a position to act". This teaching remains valid and is further confirmed, if confirmation were needed, by recent findings of human biological science which recognize that in the zygote resulting from fertilization the biological identity of a new human individual is already constituted. Certainly no experimental datum can be in itself sufficient to bring us to the recognition of a spiritual soul; nevertheless, the conclusions of science regarding the human embryo provide a valuable indication for discerning by the use of reason a personal presence at the moment of this first appearance of a human life: how could a human individual not be a human person? The Magisterium has not expressly committed itself to an affirmation of a philosophical nature, but it constantly reaffirms the moral condemnation of any kind of procured abortion. This teaching has not been changed and is unchangeable.[16]
    [edit] Islam
    Main article: Islamic sexual jurisprudence#Abortion
    Islam does not traditionally hold that ensoulment occurs at the point of conception. Two passages in the Qur'an describe the fetal development process:
    ...We created you from dust, then from a drop of fluid, then a clinging form, then a lump of flesh, both shaped and unshaped: We mean to make Our power clear to you. Whatever We choose We cause to remain in the womb for an appointed time, then We bring you forth as infants and then you grow and reach maturity. ... (22:5)
    We created man from an essence of clay, then We placed him as a drop of fluid in a safe place, then We made that drop into a clinging form, and We made that form into a lump of flesh, and We made that lump into bones, and We clothed those bones with flesh, and later We made him into other forms—glory be to God, the best of creators! (23:12-14)
    Traditional scholarship places the point of ensoulment nearer to the end of this process, naming it as anywhere between 40 and 120 days after conception, making abortion permissible until that point, though increasingly disliked as time passed.
    Contemporary scholarship, however, is more likely to more strongly restrict or even forbid abortion, on the grounds that modern technology has permitted us to perceive life in the womb earlier than was previously possible. All schools of thought, traditional and modern, make allowances for circumstances threatening the health or life of the mother.
    Muhammad ibn Adam al-Kawthari in a lecture stated that it was murder if done after three months and before that it was a crime, but not to the degree of murder.
    [edit] Judaism
  • http://www.harrisinteractive.com/vault/Harris-Interactive-Poll-Research-New-Finds-Different-Religious-Groups-H-2005-10.pdf
    57% - Steinbock Oxford Handbook Bioethics p 423
  • Roe v Wade Viability – ability to live outside womb, even via artificial supports
    There is no sharp limit of development, age, or weight at which a fetus automatically becomes viable. [2] According to data years 2003-2005, 20 to 35 percent of babies born at 23 weeks of gestation survive, while 50 to 70 percent of babies born at 24 to 25 weeks, and more than 90 percent born at 26 to 27 weeks, survive.[4] It is rare for a baby weighing less than 500 gm to survive.[2]
    [edit] Limit of viability
    The limit of viability is the gestational age at which a prematurely born fetus/infant has a 50% chance of longterm survival outside its mother's womb.
    § 16-5-80. Feticide
    (a) For the purposes of this Code section, the term “unborn child” means a member of the species homo sapiens at any stage of development who is carried in the womb.
  • Poor can’t afford IVF, storage
    Research in which hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
    Research involving the breeding of animals where the introduction of hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells may contribute to the germ line.
    Other Research Not Eligible for NIH Funding NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09), otherwise known as the Dickey Amendment.
    Research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not eligible for NIH funding.

    The Dickey Amendment (also known as the Dickey-Wicker Amendment) is the name of an appropriation's bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton which prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.

    RU486 Mifepristone can also be used in smaller doses as an emergency contraceptive; if taken after sex but before ovulation, it can prevent ovulation and so prevent pregnancy. In this role, a 10 mg dose is not as effective as the 600 mg dose, but has fewer side-effects.[7] Mifeprex and Mifegyne are only available in 200 mg tablets.[8] A review of studies in humans found that the contraceptive effects of the 10 mg dose were probably due mainly to its effects on ovulation, and not inhibition of implantation, but "the knowledge of the mechanism of action remains incomplete." Treatment with 200 mg of mifepristone changes steroid receptor expression in the fallopian tube, inhibits endometrial development, and effectively prevents implantation.[9]
  • Over 500,000. Pay for storage? Discard? Donate?
  • John Grisham movie where patient dies after being denied access to bone marrow transplantation
  • Questions?
  • More of an IVF issue. Obesity gene? Alcoholism gene?
  • Performance enhancing drugs
  • wikipedia
  • 1996 Dolly the sheep
  • Gina Kolata New York Times
  • This tremendous amount and pace of research has generated much ethical debate and discussion. Many questions have arisen, which I will group into three categories. But before we consider the specific questions, I’d like to give you a common franework for considering the ethical issues.
  • http://www.npr.org/templates/story/story.php?storyId=124616398
  • To Download - Stem Cells, Building Blocks for Tissue Engineering

    1. 1. Life, Death, and Stem Cell Research Richard L. Elliott, MD, PhD, FAPA Director, Medical Ethics Professor, Internal Medicine Mercer University School of Medicine Adjunct Professor Mercer University School of Law
    2. 2. Goals  Background – Timeline – Principles of medical ethics  Sources and fate of stem cells  Potential therapeutic uses and abuses  Access to results  Ethics and IVF – Preimplantation Genetic Determination – IVF, RU486, IUDs  Cloning
    3. 3. Recent Timeline  1978 Louise Brown IVF  1996 Dolly the sheep  1998 First human embryonic stem cells  2001 Federal funding for stem cell research limited to existing stem cell lines  2004 South Korean researchers claim first human cloned to generate stem cells  2007 Reprogramming of fibroblasts into stem cells  2009 Executive order reversed previous ban on federal funding for new embryonic stem cell lines
    4. 4. Principles of Medical Ethics  Autonomy – Informed consent of gamete donors, parents around fate of embryos  Beneficence – Potential therapeutic uses of hESC cell research  Non-maleficence – Harm to embryos  Social justice – Who will benefit? Will all have access to uses?
    5. 5. Sources of Stem Cells  Existing stem cell lines – Pre-2009 18 hESC lines approved for study using federal funding  Unused embryos from IVF – 2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far  Programmed adult skin cells (iPSC)  Umbilical cord blood  Amniotic fluid cells  Bone marrow  Fetal tissue  Somatic cell nuclear transfer
    6. 6. In Vitro Fertilization
    7. 7. IVF – In Vitro Fertilization
    8. 8. Ethical Issues and IVF-Derived hESCs  Weighing harm to embryos vs potential benefits  Informed consent  hESCs and personhood  Federal funding for hESC research
    9. 9. Beneficence and Therapeutic Potential
    10. 10. First FDA-approved Clinical Trial Using hESCs  January 2009  Geron  Spinal cord injury
    11. 11. Autonomy, NIH, Informed Consent, and hESCs  hESC derived from IVF for reproductive purposes  Available alternative uses explained  No payments for embryos  Care provided independent of decision  Should avoid clinician/researcher same  Donors gave voluntary written consent to use embryos for research
    12. 12. NIH, Informed Consent, and hESCs  Must provide information on: – Fate of embryos – Embryos may be kept for years – Research not intended as treatment for donor – What personal, potentially identifying information would be available to researchers – That research might result in financial gain for researchers, not donors
    13. 13. Non-maleficence and The Moral Status of the Embryo
    14. 14. When Does Life Begin?: Biological Landmarks  Day 1 Fertilization  Day 4-5 Cells used for hESC  Day 7-10 Implantation  Day 14 Primitive streak  Weeks 18-20 Quickening  Month 9 Delivery
    15. 15. The Moral Status of the Embryo: When is the early embryo fully human?  Aristotle and Aquinas: ensoulment with quickening  Catholic Church through 1591 – abortion before quickening not punishable  1869 - Pius IX - Excommunication for abortion at any stage of pregnancy  Multiple ethics panels concluded the embryo is a developing human deserving respect but not full rights and protections
    16. 16. Faith and Embryonic Stem Cell Research  Harris Poll 2005 – 70% Americans favor, 19% oppose – 70% Catholics, 38% born-again Evangelicals favor  57% who oppose abortion favor embryonic stem cell research – “not in womb, not abortion”  O. Hatch – opposes abortion, favors hESC research  Islam - no prohibition  Judaism – no prohibition  Hindus – unclear  MUSM research – IVF acceptable across faiths
    17. 17. Embryos and the Law  Georgia Criminal Law: “unborn child” means a member of the species homo sapiens at any stage of development who is carried in the womb.  Roe v. Wade: "We need not resolve the difficult question of when life begins. When those trained in the respective disciplines of medicine, philosophy, and theology are unable to arrive at any consensus, the judiciary, at this point in the development of man's knowledge, is not in a position to speculate as to the answer.“ May abort up to time of fetal “viability”
    18. 18. Ethics, IVF, and Stem Cells  Does use of hESCs from IVF for procreation restrict research on cells from the poor?  Is it morally acceptable to use existing stem cell lines created from embryos?  Should gamete donors and potential parents have equal rights? – Who should determine fate?  Should Federal funds be used to derive new hESC lines for research?
    19. 19. What to do with leftover embryos?  Over 500,000 embryos in storage  $100-150/year  What if donors don’t pay for storage?
    20. 20. Access to Stem Cell Benefits
    21. 21. Stem Cell Fraud, Scams and non-FDA Approved Treatments Cloned human Offshore clinics Non-FDA approved
    22. 22. Resources  Elliott_rl@mercer.edu  This presentation – Medicine.mercer.edu – search medical ethics – “resources”  NIH resources on stem cell ethics – http://bioethics.od.nih.gov/stemcell.html  International Society for Stem Cell Research – http://www.isscr.org/public/ethics.htm
    23. 23. Supplemental Slides for Dr. Elliott
    24. 24. More Complete Timeline  1974 Congress bans all federally funded fetal tissue research  Ethics Advisory Board established to set guidelines for research on fetal tissue research on tissue derived from abortions. EAB recommends federally funded research into IVF  1981 EAB disbanded, effectively ends federal funding into research on embryonic stem cells  DHHS continues moratorium on federal funding despite 18-3 recommendation for federal funding by b Human Fetal Tissue Transplantation Research Panel  1993 Moratorium on federal funding lifted  1994 Moratorium reinstated
    25. 25. Preimplantation Genetic Testing  Sex selection  Genetic “defects” – Physical characteristics
    26. 26. Stem Cells and PEDs  Should results from stem cell research be used to enhance performance? – Human Growth hormone – Anabolic steroids – EPO
    27. 27. IVF, RU486, IUDs  RU486 as an emergency contraceptive and IUDs prevent implantation  Contraception vs abortion in preventing implantation  Compare unused (non-implanted) embryos from IVF with RU486 and IUDs ethically
    28. 28. Terminology  IVF  Embryonic stem cells  Totipotency, pluripotency  Cloning
    29. 29. Cloning
    30. 30. Somatic Cell Nuclear transfer
    31. 31. Somatic Cell Nuclear Transfer  Generate stem cells with defective gene for research on disease, e.g., Parkinson’s  Use patient’s cells to generate stem cells to create tissue for transplantation that has similar immunological characteristics as patient  Hybrids  Human cloning
    32. 32. Induced Pluripotent Stem cells
    33. 33. What are areas of ethical concern?  Source and fate of stem cells  Potential therapeutic uses and abuses  Access to results  Ethics and IVF – Preimplantation Genetic Determination – IVF, RU486, IUDs  Cloning
    34. 34. NIH Guidelines for Stem Cell Lines  Pre-2009 18 hESC lines approved for study using federal funding  2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far

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