Cases of stem cell fraud in India and worldwide.

1. BY- ANKITA MURMU
M.TECH BIOTECHNOLOGY
FRAUDS IN STEM CELL

2.  Liveyon, worldwide distributor of a regenerative medicine
product was warned for its unapproved stem cell
products “putting patients at risk” due to the possibility of
microbial contamination by the US FDA.
 Liveyon’s stem cell products were increasingly being
prescribed for autism, even though the therapy
was unproven and potentially dangerous
 In September 2018, Liveyon voluntarily recalled a batch
of contaminated stem cells that sickened at least 12
people in Texas, Florida and Arizona.

3.  Liveyon opened Liveyon Labs to produce its own stem
cell therapies, described on the company’s website as
being “manufactured under the strictest safety guidelines
set forth by the FDA.” These products were sold under
the name Liveyon PURE.
 FDA issued a warning on 5th December to Liveyon, the
agency said that its inspection of the company several
months prior had revealed that Liveyon had failed to
properly screen stem cell donors for Zika virus and had

4.  Ed Garbutt, a 64 year computer parts salesman barely walked the
length of his house without gasping for breath.
 Lung Health Institute staffers reassured him by telling him that more
than 80 percent of their patients with lung disease said they found
relief through their stem cell treatments which would cost him $5,500.
 He was encouraged to take loans and go for fundraising to get
money for treatment.
 A year and a half after receiving treatments at the Lung Health
Institute, Garbutt’s health has only gotten worse. He can no longer
shop or cook.

6.  Over the past decade, hundreds of clinics have
sprouted across the United States selling stem cell
therapies for incurable conditions like Garbutt’s lung
disease, Parkinson’s disease and macular
degeneration.
 Rivero and 34 other former patients have filed a
lawsuit accusing the Lung Health Institute of
deceptive marketing practices.

7. Fraudulent cases in India
 Samir Padhiyar, a 20-year-old choreographer, was
paralysed waist down due to spinal injury in a road
accident in 2011.
 A hospital in Ahmedabad promised him absolute cure
through stem cell therapy by telling that he could walk
as before with just three stem cell injections at 3-6
months interval.
 He signed the consent form and paid them Rupees
800,000.
 No follow-up during the whole treatment that lasted
for a year
 No change in his health condition even after two
years.

8. Kothrud’s Stem Cell Bank
 MD of Kothrud’s Stem Cell Bank, Dr. Chaitanya
Purandare was found guilty of cheating customer of
Rs 65,000.
 Smita Jituri, a 60 yr old woman’s daughter Dipti
Raybagi delivered a baby whose sample was
collected by the company for stem cell storage.
 After two years, while trying to contact the employee
they were in touch with, the employee refused to
answer.
 They were told that the stem cells have been shifted
and when asked about new address, they were given
wrong address.

10. Story so far in India…
 Rs 5,000 to 1.5L charged to store stem cells up
till 21 years, disposed after that age.
 Rs 3L to 12L is the cost of stem cell therapy
 1:40,000 is the probability of a family to use its
own stored Cord Blood (CB)
 21 CB banks registered with CDSCO (Central
Drugs Standard Control Organisation). More than
500 unregistered
 500m cells can treat a person of only 15 kg
weight, which a child attains at much before 10
years
 5 rare diseases are curable through stem cell
therapy against 80 in all claimed by private firms

11. Frauds in Stem Cell Research
 Hwang Woo-suk and his research team said they had
successfully cloned a human embryo and produced
stem cells from it
 He was sentenced to two years in prison at the Seoul
Central District Court on 26 October, 2009.
 He was charged with embezzlement and bioethics
law violations
 Found guilty of buying human eggs in violation of the
country's bioethics law and of embezzling 830 million
won (US$700,000) of government money.
 His human cloning experiments were revealed to be
fraudulent.

13. Scandal of STAP (stimulus-triggered acquisition of pluripotency)
cells
 Yoshiki Sasai, one of Japan’s foremost
developmental biologists along with Haruko
Obokata, a thirty-year-old postdoctoral
researcher reported the discovery of a new
phenomenon the researchers called
stimulus-triggered acquisition of
pluripotency (STAP).
 Ordinary cells could be turned into stem
cells by subjecting them to profound stress.
Few cells could survive the abuse, but those
which did emerged transformed, apparently
able to make any cell in the body. Sasai

15.  They published papers, whose lead author was
Haruko Obokata, which appeared online in Nature but
retracted after months of mounting claims of problems
and a finding of research misconduct by Obokata by a
RIKEN committee.
 The retraction notices cite duplicated and mixed-up
images, mislabeling, faulty descriptions, and
"inexplicable discrepancies in genetic background
and transgene insertion sites between the donor mice
and the reported" STAP cells.
 However, she tried to replicate her own study using
genetically manipulated mouse spleen cells that glow
green if a gene indicative of pluripotency is activated.
She failed to reproduce the ‘STAP cell’ to back up her
claimed discovery.

17. conclusion
 Beware of potentially dangerous procedures and
confirm what’s really being offered before you
considering any treatment.
 Parents who seek to preserve the umbilical cord stem
cells of their newborn in a private cord blood bank
should be aware of companies that make unfounded
claims for their healing powers, and should
investigate the alternatives available in their area,
such as public or hybrid cord blood banking
programs.
 In many parts of the world cord blood banking is a
"buyer beware" market. Parents need to check with
independent and authoritative sources to find out
what diseases can really be treated with which cells,
and what is the current state of clinical trials on new
therapies.
 Stem cell research must be carried out aligning with

18. References
 https://www.sciencemag.org/news/2014/08/senior-riken-scientist-involved-stem-
cell-scandal-commits-suicide
 https://en.wikipedia.org/wiki/Haruko_Obokata
 https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-
therapies
 https://www.newyorker.com/magazine/2016/02/29/the-stem-cell-scandal
 https://en.wikipedia.org/wiki/Hwang_Woo-suk
 https://www.telegraphindia.com/india/stem-cell-march-minus-checks-lack-of-
research-rules-allows-doctors-to-do-as-they-like/cid/839531
 https://timesofindia.indiatimes.com/city/mumbai/experts-dub-doctors-stem-cell-
technique-flawed-fraudulent/articleshow/63888577.cms
 https://ijme.in/articles/stem-cell-transplantation-in-india-tall-claims-questionable-
ethics/?galley=html
 https://www.washingtonpost.com/national/health-science/clinic-pitches-unproven-
treatments-to-desperate-patients-with-tips-on-raising-the-
cash/2019/12/01/fe94cfcc-d3c6-11e8-8c22-fa2ef74bd6d6_story.html
 https://www.spectrumnews.org/news/u-s-agency-warns-company-marketing-
stem-cells-for-autism/
 https://www.fda.gov/news-events/press-announcements/fda-sends-warning-
companies-offering-unapproved-umbilical-cord-blood-products-may-put-patients-
risk
 https://punemirror.indiatimes.com/pune/civic/kothruds-stem-cell-bank-md-
booked-by-police-for-cheating-customer-of-rs-65k/articleshow/62318644.cms