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(go to www.calendly.com/qcm for Q+A)
Amniotic Fluid-Derived
with Extra Cellular
Vesicles "ECV’s"
Amnio Matrix is an acellu...
Chart from Dr. Arnold Caplan who is considered the “father of MSCs
Tremendous Loss of
Regenerative
capacity as we age
- By...
Parabiosis –taking youth from the young to fix the old
Rejuvenating factors provide
tissue repair and anti-aging.
The most...
The heart of the third
trimester mother is akin to
that of an elite athlete,
except that the race is for
three months inst...
Amniotic Fluid and Tissue Provides Everything Needed
Amniotic Fluid contains Hyaluronic Acid,
over 300 growth factor, Chem...
Amnio MatrixTM
Breakthrough in Regenerative Therapeutics
Amnio Matrix is derived from the amniotic fluid and tissue of heal...
Amnio MatrixTM
Breakthrough in Regenerative Therapeutics
1. Far more powerful than any other exosome product in the market...
Filtered Sterilized
All manufacturing is
performed by qualified,
trained scientists under
cGMP laboratory with
a ISO7 clean...
The difference between MatrixTM
and
alternative amniotic products.
Not all extracellular vesicles are exosomes
Nanosomes a...
RAADfest Patient Clinical Assessment of Amnio-Matrix
(naturally occurring hyaluronic acid, 300+ growth factors and exosome...
Five-Patient Clinical Assessment of Amnio-Matrix
•Treatments starts as soon as convenient for patient (ideally soon).
•Beg...
Age Reversal Network 90-Day or 360-Day Assessment Program
(participants are limited please go to www.calendly.com/qcm for ...
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Bill Faloon on Extracellular Vesicles from amniotic fluid RAADfest 2021

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These are Bill Faloon's slides for his presentation at RAADfest 2021 about the therapeutic potential of amniotic-fluid-derived extracellular vesicles.

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Bill Faloon on Extracellular Vesicles from amniotic fluid RAADfest 2021

  1. 1. (go to www.calendly.com/qcm for Q+A) Amniotic Fluid-Derived with Extra Cellular Vesicles "ECV’s" Amnio Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only Amniotic Fluid-Derived with Extracellular Vesicles "EV’s" AMNIO MATRIX
  2. 2. Chart from Dr. Arnold Caplan who is considered the “father of MSCs Tremendous Loss of Regenerative capacity as we age - By teenage years there is 90% decrease in regenerative capacity - 50 yr old bone marrow cells provide only 2.5% MSC’s for regeneration This is why we are committed to using the highest quality perinatal products. Loss of Regenerative capacity
  3. 3. Parabiosis –taking youth from the young to fix the old Rejuvenating factors provide tissue repair and anti-aging. The most potent of these factors are extracellular vesicles. Indeed, these EVs are the mechanism by which the “paracrine effect” works when MSCs and other regenerative cytotherapy is given to patients. It’s not the cells of the young individual, it’s mostly the EVs that provide the messaging payload to create the cell rejuvenation. Exosomes are the main EV’s. (go to www.calendly.com/qcm for Q+A) Young blood added to old blood is called heterochronic parabiosis Harvard Medical School, UCLA and UC San Francisco and other institutions have created papers demonstrating the striking benefits of young blood on cognitive function, synaptic plasticity, neurogenesis, and the cerebral vasculature of old mice. The beneficial effects are not limited to the brain, and the operative factors can be identified, as one study reports that growth differentiation factor GDF11 empowers young blood to bestow regenerative oomph to old muscle. 2014 Zilkha Symposium on Alzheimer’s Disease and Related Disorders | ALZFORUM
  4. 4. The heart of the third trimester mother is akin to that of an elite athlete, except that the race is for three months instead of minutes. If a male or non- pregnant woman tried to maintain this level of cardiac output they would die. Nanosomes shared by the fetus, placenta and mother, protect the mother from the stresses and rigors of pregnancy. Pregnancy: A natural example of heterochronic parabiosis. Amnio Matrix: Amniotic fluid EVs (Extra Cellular Vesicles) are the ultimate toolbox for tissue growth and repair and immune modulation. All of the physiological changes the mother experiences, tissue growth, immune modulation, etc must come from communication with the fetus via Nanosomes found in Amniotic Fluid. All the material supplies needed for fetal growth must be delivered within an exquisitely refined inventory of EV’s via Growth Factors, Chemokines, Hyaluronic Acid combined with Nanosomes in Amnio Matrix. Unique and specific cargo ratios only seen in natural amniotic fluid filtered and concentrated and sterilized into Amnio Matrix. Heterochronic parabiosis –pregnancy Amnio Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only
  5. 5. Amniotic Fluid and Tissue Provides Everything Needed Amniotic Fluid contains Hyaluronic Acid, over 300 growth factor, Chemokines, Cytokines and an abundance of Mesenchymal Stem Cells “MSC’s” which release Extracellular Vesicles “EV’s” to signal and direct the production of all the cells needed to create a complete healthy body. Amnio Matrix captures this regenerative capacity. Amnio Matrix is an acellular amniotic derived, minimally manipulated tissue available for research purposes only (go to www.calendly.com/qcm for Q+A)
  6. 6. Amnio MatrixTM Breakthrough in Regenerative Therapeutics Amnio Matrix is derived from the amniotic fluid and tissue of healthy, full-term, c-section births carefully screened socially and physically tested. A detailed questionnaire of over 60 pages is used to screen donors in addition to testing. The miraculous synergy of hyaluronic acid, 300+ growth factors, chemokines and cytokines are included with the naturally occurring Nanosomes which are the core regenerative extracellular vesicles "EV's" messengers. They are measured to be between 50–150 nm in size. As such they can pass though the placental barrier and the blood-brain barrier. Unlike exosomes derived from culture-expanded placental MSCs, Amnio Matrix is acellular allograft produced by filtering the heterogeneous population of regenerative cells including epithelial cells, endothelial and hematopoietic progenitors and mature leucocytes (white blood cells), etc. However, the main Nanosome content of the Amnio Matrix come from what the Mesenchymal Stem Cells “MSC” have released. They accumulate in the amniotic fluid during pregnancy (a phase of pro-growth and anti-inflammation) creating a regenerative fluid and tissue which is advantageous over sole EVs created by culture-expanded cells. Our clinic has a foundation of 20 years of experience in regenerative therapy with an unchanging passion to improve patient outcomes. This gave birth to the research and development years working with patients to develop Amnio Matrix. Amnio Matrix represents a breakthrough in regenerative Nanosome therapeutics. Far more powerful than any other EV product in the market. Far more flexibility in treatment than any other EV product in the market. (go to www.calendly.com/qcm for Q+A) Amnio Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only
  7. 7. Amnio MatrixTM Breakthrough in Regenerative Therapeutics 1. Far more powerful than any other exosome product in the market. Amnio Matrix has more Nanosomes per cc measured by third party testing. Through a proprietary method of carefully stressing the mesenchymal stem cells in the Amniotic fluid Matrix achieves this high yield. When compared to other exosome products it has 5 to 10 times more Nanosomes per cc. A vial of Amnio Matrix is 1.5 cc. It contains on several trillion Nanosomes in each vile. The laboratory is in full compliance with cGMP and cGTPs. Each batch is sent for 3rd party testing per specific release criteria in accordance with FDA guidelines. In the most recent 3rd party testing Amnio Matrix batches showed over 6 trillion Nanosomes in the 1.5cc vial. This concentration of 4 trillion Nanosomes per cc represents 5 times more than what reported by the closest competitive product and over 10 times more than most of the market. 2. Multiple injections from one vial. Matrix is developed with a proprietary manufacturing method as compared to other exosome products. This allows for reconstitution with saline or PRP allowing for multiple injections. This allows the clinic to perform multiple treatments (2 to 4) per vial which brings the cost way below other products in the market. (go to www.calendly.com/qcm for Q+A) Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only
  8. 8. Filtered Sterilized All manufacturing is performed by qualified, trained scientists under cGMP laboratory with a ISO7 clean room. Release criteria including sterility is tested by independent third party labs. The raw amniotic fluid is collected by FDA- approved and AABB accredited cord-blood banks within the USA and shipped overnight to our labs. Mothers are consented and tested for infectious diseases and other exclusion criteria at the time of normal full term pregnancy in situation of planned delivery by C-section. Centrifuged Using proprietary techniques, requiring minimal manipulation of the material, raw amniotic fluid is transformed into Amnio MatrixTM. The vials are quarantined for 14 days while lots are tested by independent labs for sterility and endotoxin. We have a 100% clean record over the 3 years that our scientists have been producing Amnio MatrixTM. Vials are shipped on dry ice within tamper- proof insulated shippers, together with product details and a certificate of analysis. Prior to delivery the vials should be stored in a -80c degrees freezer. The cryovials are never submerged in the liquid phase of liquid nitrogen. Manufactured at the highest quality standards (go to www.calendly.com/qcm for Q+A) Amnio Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only
  9. 9. The difference between MatrixTM and alternative amniotic products. Not all extracellular vesicles are exosomes Nanosomes are between 50-150 nm and require a specific profile. Larger EVs are non-regenerative microvesicles and “apoptotic bodies” produced by dying cells. We use a propriety method for filtering micronized material. Then we apply our proprietary sterilization process which no other laboratory has. The retained EVs need to have a balanced profile of surface proteins CD9, CD63 and CD81. In the recent 3rd Party testing Amnio Matrix showed over several trillion exosomes per 1.5ml. (go to www.calendly.com/qcm for Q+A) Amnio-Matrix is an acellular amniotic derived minimally manipulated tissue available for research purposes only ZetaView Analysis SAMPLE PARTICLE DIAMETER (nm) CONCENTRATION Mean Mode (particles/mL) AMNIO MATRIX Vial 1 134.2 92.5 6.30E+12 AMNIO MATRIX Vial 2 133.9 92.5 6.10E+12 AMNIO MATRIX Vial 3 137.1 87.5 7.00+12 0 20 40 60 80 100 120 140 160 CD9 CD63 CD81
  10. 10. RAADfest Patient Clinical Assessment of Amnio-Matrix (naturally occurring hyaluronic acid, 300+ growth factors and exosomes) (go to www.calendly.com/qcm for Q+A) QCM Clinics, Age Reversal Network, Brazelia Integrative Wellness. Test of the effects of an amniotic fluid–based regenerative medicine product on markers of aging, inflammation, and kidney function. The product comes from a fully FDA compliant cGMP laboratory with an ISO 7 certified clean room. •Participants: 5 healthy patients, ages 65 to 85. (Those not meeting these criteria can participate in other ways.) •Each participant to receive 2 treatments in total of 1.5 ml Amnio-Matrix. •Treatments on Day 0 and Day 30. •Assessments done on Day 0 and Day 45. •Assessments: Clinical measures (done at Brazelia Integrative Wellness Center) • Short health assessment questionnaire • MMSE (Mini Mental State Exam) • Blood pressure • 30 second sit-to-stand test •Assessments: Blood tests (done via Life Extension®/Lab Corp) • Life Extension Male/Female Panel • IL-6 • TNF-alpha • Cystatin-C Summary of clinical assessment
  11. 11. Five-Patient Clinical Assessment of Amnio-Matrix •Treatments starts as soon as convenient for patient (ideally soon). •Begin by contacting David Konn at QCM. Go to www.calendly.com/qcm to schedule a Zoom appointment dck@qcmedicine.com, 561-602-0484. •Step 1. Have blood draw for blood tests at Life Extension® Nutrition Center in Fort Lauderdale, Florida. •Step 2. Visit 1 to Brazelia Integrative Wellness, Boca Raton, Florida. (Commence treatment within five days of blood draw.) • Initial clinical tests. • First treatment. •Step 3. Visit 2 to Brazelia Integrative Wellness on day 30. • Second treatment. •Step 4. Visit 3 to Brazelia Integrative Wellness on day 45. • Final clinical tests. •Step 5. Return to Life Extension® Nutrition Center on or close to day 45 for second and final blood draw. •Other details to be provided by David Konn and Dr. Brazelia Lazzari. QCM and Brazelia Med Spa are interested in continuing to gather information about the efficacy of amniotic fluid– based regenerative medicine products. Anyone interested in this treatment, whether or not they qualify for the current clinical assessment, can contact David Konn about a longer-term, ongoing assessment that can be made available at a significant discount for research purposes. Go to www.calendly.com/qcm to schedule a Zoom appointment Requirements for patients Option on Next Page for those who don’t qualify or are not selected
  12. 12. Age Reversal Network 90-Day or 360-Day Assessment Program (participants are limited please go to www.calendly.com/qcm for Q+A) **OPTION 1: 3 Month Regeneration and Renewal Registry program with two treatments and Bio Impedance testing with a research discount of 20% **OPTION 2: 12 month Annual Complete Regeneration and Renewal Registry with four treatments and Bio Impedance testing with a research discount of 37% QCM Clinics, Age Reversal Network, Brazelia Integrative Wellness Center. Test of the effects of an amniotic fluid–based regenerative medicine product via before and after questionnaire on aging, inflammation, and overall wellness with advanced electro dermal screening. The product Amnio Matrix comes from a cGMP ISO 7 certified clean room laboratory. Two options for this Age Reversal Network Patient Registry Send email to DCK@QCMedicine.com

These are Bill Faloon's slides for his presentation at RAADfest 2021 about the therapeutic potential of amniotic-fluid-derived extracellular vesicles.

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