Bill Faloon on Extracellular Vesicles from amniotic fluid RAADfest 2021
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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