Clinical Trials Update by Bill Faloon at RAADfest 2021

Clinical Trials Update
William Faloon
RAADFest
October 2021

Where We Are with
Human Age Reversal
Aging has been delayed and reversed
in animal models.
Human data show partial age delay and
reversal using existing therapies.
Clinical trials urgently needed to
validate current approaches.

Thousands of People Engaging in Different
Experimental Age Reversal Interventions
How Do We Validate What’s Working?

Betterhumans Human Research
Clinical Trials Medical Office Opens October 2021

Clinical Trials Center in Florida

Betterhumans Clinical Trials Medical Office
TheVillages, Florida

Betterhumans Clinical Trials: Exam Rooms

GE Luna Prodigy X Dexa Scan
 Visceral fat
 Bone density
 Muscle mass
Visceral fat
Bone density
Muscle mass
Measures:

Sterile Hood-Centrifuges to Process Blood
at BetterHumans Clinical Trials Office
for Immediate Assays

Betterhumans laboratory measures:
Horvath Clocks (DNA methylation/Epigenetic
Aging), using Illumina iScan sequencers.
Expression of 20,000 genes using Ion Torrent
whole-Transcriptome RNA sequencing.
Pro- and anti-inflammatorycytokine levelsusing
immunofluorescence assays(also measures some
SASPs – senescent cellsecretoryphenotypes).
NAD+ measurements by mass spectrometer
(40 times more sensitive than a few years ago).
Precise Evaluation of Biologial Age

Betterhumans DNA/RNA/DNA Methylation Sequencing Room

Betterhumans Mass Spectrometry Room

Health and Longevity Biomarker Assay Facility

"Exosomes" Scientist, Monal Sharma, PhD working at Betterhumans Lab

Biogerontology Researcher James Clement in Front of 10,000 Square Foot Church being
Converted to advanced Analytical Test Lab to Measure Effects of Age Reversal Interventions
Betterhumans new lab near Tyler Texas

Inside 10,000 Square Foot Church Before Remodeling Commences

2022 Betterhumans Projects List
1) Epigenetic-reprogramming exosomes derived from placental MSCs to suppress chronic inflammation;
2) Individually-grown autologous iPS cells from MSCs and HSCs for restoration of aged bone marrow;
3) Reduction/reversal of Advanced Glycation End products via dietary and compound interventions;
4) Measurement and reduction of bacterial and viral blood loads in elderly subjects;
5) Transplantation of mitochondria from autologous iPS cells;
6) Replacement of misfolded and glycosylated circulating proteins in elderly subjects;
7) Continue studies to inexpensively replenish NAD+ levels in elderly subjects;
8) Continue studies to inexpensively remove senescent cells, along with measurements of SASP cytokines;
9) Measure effects of rapamycin for others on autophagy, mTOR suppression and epigenetic profiles
As of August 1st,2021 email communication (wwws.Betterhumans.org)

Rapamycin Human Study
Receives $485,000 Funding
 Randomized, placebo-controlled trial into the safety/efficacy of rapamycin in
reducing clinical measures of aging in an older adult population.
 Two differing doses: 5 mg or 10 mg of rapamycin one time a week or placebo.
 Primary Outcome Measure: Changes in visceral fat as measured by (DXA) scan.
 Secondary Outcomes: Range of clinical measures, e.g. bone density, blood tests, etc.
 20 people enrolled at $360 each (original cost before donations was $1,200).
Sponsor: AgelessRx Collaborator: University of California, Los Angeles
Principal investigators: James Watson, M.D. and Sajad Zalzala, M.D.
June 18, 2021
To enroll log on to: https://www.agelessrx.com/pearl

Dr. Alan Green at his practice in Little Neck, NY
now has >700 patients using rapamycin with >
100 patients adding dasatinib, fisetin and
quercetin .
Dr. Green’s Anti-Aging Cocktail
1) Rapamycin
2) Dasatinib
3) Fisetin
4) Quercetin
Now in Clinical Use:
https://senolyticstreatment.com/

Dr. Alan Green’s Senolytic Protocol
 Dasatinib: 100 mg a day for 3 days
 Quercetin: 1000 mg a day for 3 days
 Fisetin: 1500 mg day for 3 days
https://senolyticstreatment.com/
These are maximum doses. Patients determine sensitivity with smaller doses.
For diseases like Alzheimer's, cardiomyopathy, pulmonary fibrosis, emphysema,
fatty liver, chronic kidney disease, metabolic syndrome, obesity, frailty:
1-2 of these senolytic treatments a month
For lifespan and healthspan: 4 treatments a year (3-month) interval

New York-based biotech raises $60 million to develop a
pipeline of companies and therapeutics to treat diseases of
aging…
Cambrian Biopharma has 3 major categories of aging at the top
of its to-do list:
1) Tackle intracellular dysfunction (things that go wrong inside
cells, such as mutating DNA or shrinking telomeres);
2) Cellular dysfunction (whole-cell level problems, such as
senescence or energy pathway break down);
3) Tissue level dysfunction (stem cells exhaustion, chronic
inflammation, or breakdown of tissue architecture).
February 9, 2021
https://longevity.technology/cambrian-biopharma-exits-stealth-with-60m-and-affiliate-ipo/

“Put simply, I want to
live forever! And in
perfect health!
And it is my sincere
belief that we will
achieve the means to
do this within the next
20-30 years.”
https://longevity.technology/david-sinclair-to-co-chair-200-m-spac/
$200 million Biotech SPAC
March 11, 2021
Christian Angermayer, Chairman &
Co-Founder of Cambrian Biopharma

https://longevity.technology/senescence-reversing-start-up-lands-1-3m-in-funding/
Senescence-reversing start-up lands
£1.3M in funding
March 12, 2021
University of Exeter spin-out SENISCA has developed a
platform for the development of oligonucleotide-based
medicines that reverse cellular senescence and “reset
the cellular aging clock.”
The company revealed it was looking for around £950k
in initial seed funding, so the nicely oversubscribed
round indicates strong investor interest.
12

Experimental Human Age Reversal Interventions
How We Plan to Rapidly Assess Efficacy

New logo for non-profit human research group
funded by Bill Faloon and related entities
www.VitalityInAging.org/

Human Interventions Clinical Trial:
VIAging Deceleration Trial
www.VitalityInAging.org/

VIAging Deceleration Trial Using Metformin,
Dasatinib, Rapamycin and Nutritional
Supplements
Sponsor:
Vitality in Aging Research Group, Inc.
Brief Summary:
“This study aims to assess the safety and efficacy of study drugs
and supplements on clinical (structural and functional) signs of
aging and to explore/identify other possible biological measures
of aging.”
Information provided by (Responsible Party):
Vitality in Aging Research Group, Inc.
https://clinicaltrials.gov/ct2/show/NCT04994561?term=04994561&draw=2&rank=1

VIAging Deceleration Trial
To indicate your interest in enrolling log on to: www.VitalityInAging.org/
 Recruit 50 people 65 years of age or older in South Florida
 Funded by Human Age Reversal Project and BioFutures, LLC
 18-month study using at least 4 interventions simultaneously
 This clinical trial fully funded---no cost to study participants

metformin
dasatinib/quercetin/fisetin
infusions, patches, precursors
rapamycin, glucosamine
resveratrol, reduce calorie intake
Induce autophagy
Advance to “biologics”, i.e., exosomes, perinatal tissues, growth hormone et al.
glucosamine, rapamycin, diet
Express sirtuins
Suppress excess mTOR
Boost cellular AMPK
Reduce senescent cells
Replenish NAD+

Human Age Reversal Project
$1,080,300
Goal: Statistically Significant
Human Age Reversal

Fund Research with Tax-Deductible Donations
Make checks payable to:
3600 West Commercial Blvd.
Ft. Lauderdale, FL 33309
Or donate online:
age-reversal.net/donate

Urgent Need for Consensus
On Effective Interventions
Human
Age-Reversal
Pathway to Super Longevity

Aging Science: Where Were We 12 Years Ago?
( . . . in our understanding and treatment options for aging)
Manhattan Beach Summit
November 2009
NO Validated Method to Reverse Aging in Humans
2009

Huge Advances in 12 Years
No Way to Reverse Aging
Manhattan Beach Summit Attendees
November 2009
Many Potential Methods
2009 2021

( Roadmap to Accelerated Human Age Reversal
• Early 1900s. High blood pressure NOT considered a
“DISEASE” – no need for treatment.
• 1932. Franklin D. Roosevelt – At age 50, had high blood
pressure.
• 1932-1945. FDR’s blood pressure worsened as he
gradually developed signs of heart failure.
• 1945. FDR died of untreated hypertension (hemorrhagic
stroke). At the time of his death, his blood pressure was
300/140 mm Hg.
Died at
age 63
Franklin D. Roosevelt’s Premature Death

Learning from History
• Fact: FDR died at age 63 of hypertension – a
condition his doctors thought “normal for his age”.
• Reaction: As a result of FDR’s untimely death,
doctors started questioning the conventional
wisdom about hypertension.
• Result: FDR’s death was a major reason why the
Framingham Heart Study was proposed and
funded.

Began in 1948 with 5,209 adults in Framingham, Massachusetts
Prior to Framingham little was known about
hypertension/cardiovascular risks
Doctors did not know how to prevent heart attacks
Atherosclerosis was thought to be unavoidable aspect of aging
Framingham Heart Study
Millions of Lives Saved

Enormous Decrease in Cardiovascular Deaths
1. “Trends and Patterns of Geographic Variation of Cardiovascular Mortality 1980-2014”
Journal of the American Medical Association (JAMA); May 16th 2017
Between 1980 and 2014
`
-50%
Decrease in Deaths from
Heart Disease

Similarities between FDR’s death in 1945
& Death from age-related disease in 2021
• 1945 – FDR dies of hypertension.
• 1945 – Hypertension not
recognized as a disease.
• 1945 – Cause of hypertension not
well understood.
• 1950s – Progress begins for
treating hypertension...
• 2021 – Millions die from aging.
• 2021 – Aging barely recognized as
disease by medical establishment.
• 2021 – Molecular causes of aging
increasingly being understood.
• 2021 – Discovery of treatments for
aging to ↑ health span/lifespan.

Lyndon Johnson Prematurely Aged
and Died Due to Technology Delay
•First heart attack at age 46 (1955)
•Suffered chronic angina pain
•Resigned re-election at age 59
•Dead at age 64 years (1973)
(Conventional Treatments Lacking)

Alive Because of Biomedical Technology
Bill Clinton
Coronary Bypass Age 58
In 2004
Coronary Stent Age 63
In 2010
George W. Bush
in 2013
Dick Cheney
Coronary Bypass Age 47
In 1988
in 2000
Ventricular Assist Age 69
in 2010
Heart Transplant Age 71
in 2012

Reasons for 50% decline
in Cardiac Deaths
•Healthier Diet/Lifestyle
•Better Prevention Techniques
•Improved Emergency Response
•Coronary Artery Bypass Surgery
•Coronary Artery Stenting
These approaches not developed
or widely practiced in LBJ’s era. Coronary Artery Bypass Graft
Quadruple Bypass

Life Extension’s Role in Declining
Cardiovascular Deaths
1981: DHEA replacement
1981: Homocysteine reduction
1983: Low-dose aspirin
1983: Coenzyme Q10
1996: Public access to blood tests
We defied conventional reference ranges
for optimal glucose, LDL, blood pressure.

Age Management Telehealth Physicians
www.age-reversal.net
Modeled on Framingham Heart Study
Purpose: Validate What Works to Delay/Reverse Aging
Long term and
ongoing
No upper age
threshold
At least 10-
Year study
period

1) Age Management Blood Test Panel with Omega-3 Index
2) Online questionnaires, consent, data capture
3) Consultation with telehealth age management physician
4) Continual updates on your biological age
To indicate your interest: www.age-reversal.net
(Select “Telehealth Study” link from Home Page)
Purpose: Collect data to assess predictive value of biomarkers
Age Management Telehealth Physicians Case Study

Online telehealth service extracts data from
CBC/metabolic panel plus C-Reactive Protein
test report, then calculates the implied
phenotypic (biological) age values, as well as
estimated DNAm Age, and others.
Assess Your Biological Age!
Age Management Telehealth Physicians Case Study
Select “Telehealth Study" link from Home Page

They then used the measures to calculate implied
phenotypic (biological) age and others shown in
the spreadsheet below (Bill Faloon’s most recent)
Bill’s calculated phenotypic (biological) age
11.12 younger than chron age
and difference

Morgan Levine PhD and Steve Horvath PhD
discovered standard blood test measures
correlate with DNA methylation age:
• Albumin
• Creatinine
• Glucose
• C-reactive Protein
• Lymphs (Lympocyte)
• MCV (Mean Cell Volume)
• RDW (Red Cell Dist Width)
• Alkaline Phosphatase
• WBC (White Blood Cells)
Reference: "An epigenetic biomarker of aging for lifespan and healthspan", Aging (Albany NY) 10(4) 573-591 (2018 Apr 18).
(Life Extension® price for CBC/Chem + C-reactive protein: $77)

Some features of the online data
management and analysis system:
• Calculates Levine/Horvath implied phenotypic (biological) age
and others –useful measures to track progress
• Easy to see “timeline” – before and after biomarker results,
therapies and notes
• Charts showing biological marker progress
• Easy-to-enter
• Lab test results
• Therapies
• Notes
• For many LabCorp PDF lab test reports, data can be extracted
and automatically uploaded into the system

Graphs showing how subject is progressing:
These graphs show Phenotypic Age, C-Reactive
Protein, albumin moving in positive directions
after age reversal interventions.

AGE MANAGEMENT
TELEHEALTH PHYSICIANS
Physicians will see patients via the telehealth portal for this case
series study.
They will be trained in innovative age management therapies.
Physicians will assist in inducing biological age reversal in the way
they best see fit for each subject’s individual needs. (Personalized
medicine.)

Problems reported by many of our
members who would like to visit a
physician to reduce their biological ages:
• Can’t find a QUALIFIED age management physician
in their local area
• Commute time takes too long
• Would rather not travel to a doctor’s office.
Solution:
AGE MANAGEMENT

AGE MANAGEMENT
PRIMARY OBJECTIVE: Use a telehealth platform to conduct single case
studies where doctors and patients visit remotely via video.
Various interventions assessed as to their safety and efficacy in
inducing biological age reversal and improved general health.
END RESULT SEEKING: Better understanding and refinement of
regenerative interventions using a clinical (doctor/patient) telehealth
setting.
Select “Telehealth Study" link from Home Page

https://www.wsj.com/articles/a-cancer-patients-brutal-commute-11626129627?mod=searchresults_pos2&page=1
July 12, 2021
“She doesn’t have
to go all the way to
the doctor’s office,
a 5½-hour drive
each way. She
can drive 3½
hours, cross the
border into
Massachusetts,
pull over, and
have a
telemedicine visit
“A Cancer Patient’s Brutal
Commute”

Analogy: Framingham Heart Study and
Age Management Telehealth Study
seeks to do for aging what the
Framingham Study did for our
scientific understanding of heart
disease and hypertension.

metformin
dasatinib/quercetin/fisetin
infusions, patches, precursors
rapamycin
resveratrol, reduce calorie intake
Induce autophagy
Advance to “biologics”, i.e., exosomes, perinatal tissues, growth hormone et al.
glucosamine, rapamycin, diet
Express sirtuins
Suppress excess mTOR
Boost cellular AMPK
Reduce senescent cells
Replenish NAD+

Bridging the Longevity Gap
Bureaucratic Delays Impede Progress

 Apolipoprotein B
 Omega-3-Index
 Homocysteine
 C-Reactive Protein
 LDLparticle number
 Total cholesterol
 LDL cholesterol
 HDL cholesterol
 Triglycerides
 T. Chol/HDL Ratio
 Est. Heart Disease Risk
+
Conventional Risk Factors
More Tests on Next Slide
AgeManagement TestPanel
Cardiac and Inflammatory Blood Markers
Added RiskFactors
 Small dense LDL
 LDL size
 Insulin Resistance
 VLDL cholesterol
 HDLparticle number

Omega-3 Index + Full Fatty Acid Profile
Omega-3 Fatty Acids
• Omega-3 Index
• Alpha-Linolenic
• Eicosapentaenoic (EPA)
• Docosapentaenoic-n3 (DPA)
• Docosahexaenoic (DHA)
Omega-6 Fatty Acids
• Linoleic + Gamma-Linolenic
• Eicosadienoic
• Di-homo-gamma-linolenic
• Arachidonic
• Docosatetraenoic
• Docosapentaenoic-n6
Monounsaturated Fats
• Palmitoleic
• Oleic
• Eicosenoic
• Nervonic
Saturated Fatty Acids
• Myristic
• Palmitic
• Stearic
• Arachidic
• Behenic
• Lignoceric
Trans Fatty Acids
• Trans Palmitoleic
• Trans Oleic
• Trans Linoleic
• Trans Fat Index
Fatty Acid Ratios
 AA: EPA ratio
 Omega-6 to-
Omega-3 ratio

Glycemic Control Blood Profile
Insulin
Hemoglobin A1C
Ferritin
Insulin Resistance Score
Glucose
Diabetes Risk Markers

Hormones +Vitamin D + Binding Protein
 IGF-1 (growth hormone)
 IGF1BP3 (binding protein)
 DHEA-S
 Free Testosterone
 Total Testosterone
 Estradiol
 Progesterone
 TSH (thyroid)
 Free T3 and Free T4
 Vitamin D 25-Hydroxy
Hormone Effectiveness Profile

Kidney and Liver Function Biomarkers
 eGFR
 LDH
 AST
 ALT
 GGT
 Bilirubin
 Albumin
 Globulin
 A/G ratio
 Creatinine
 BUN/Creatinine
 BUN
 Total protein
 Alkaline Phosphatase
Measures of Organ Function

Blood Mineral-Electrolyte Balance
Potassium
Magnesium
Ferritin (iron storage)
Measures of Mineral-Electrolyte Balance
Calcium
Iron
Chloride
Sodium

Blood Oxygen Carrying Capacity
 MCV (meancorpuscularvolume)
 MCH (meancorpuscularhemoglobin)
 RDW (redcelldistributionwidth)
 MCHC (meancorpuscularhemoglobinconcentration)
 Platelets
 Hematocrit
 Hemoglobin
 Red blood count
 Ferritin (ironstorage)

Circulating Immune Cell Count
 Immature cells
 White blood cells
 Immature granulocytes
 Neutrophils (% and absolute)
 Lymphocytes (% and absolute)
 Monocytes (% and absolute)
 Eosinophils (% and absolute)
 Basophils (% and absolute)

For Men
PSA
(prostate-specific antigen)

Commercial Lab Price: $3,000
TeleHealth Price: $495
Age Management BloodTest Panel
age-reversal.net

Tragedy of Lost Data
*Critical Need for
Age Management Blood Tests
Baseline and Annual Follow-Ups
Experimental Therapies Need Meticulous Validation
To inquire about Age Management Telehealth Physicians study: age-reversal.net

Age Management Blood Test Panel
The Telehealth Study Price of $495 available until Nov 5th, 2021 at:
www.age-reversal.net
Results help assist your physician to identify degenerative aging factors.
Quest Labs
Telehealth Physicians Study
$3,000
$495

Who missed the longevity boat?
Eli Broad
(1933 - 2021)
Expiration date: Apr. 30, 2021
net worth > $6.8 billion https://en.wikipedia.org/wiki/Eli_Broad
• American billionaire philanthropist.
• Funded genomics research to advance
understanding of the biology of human disease.
• Funded Regenerative Medicine and Stem Cell
Research at USC.

Urgent Need for Consensus
On Effective Interventions Age-Reversal
Pathway to Super Longevity

Bridging the Longevity Gap
Urgent Need to Reform Clinical Trial Regulations

Copyright ©Life Extension®. Confidential and proprietary.
How I Fund Age Reversal Research
Supplement Sales Support Rejuvenation Projects

age-reversal.net
For information about current
regenerative medicine research:

Clinical Trials Update
William Faloon
RAADFest
October 2, 2021

Clinical Trials Update by Bill Faloon at RAADfest 2021

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