Actively Recruiting

Phase 1
Phase 2
Age: 45Years - 75Years
All Genders
Healthy Volunteers
NCT07443826

CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy

Led by Unlimited Biotechnology LLC · Updated on 2026-03-06

12

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

Sponsors

U

Unlimited Biotechnology LLC

Lead Sponsor

G

Global Alliance for Regenerative Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.

CONDITIONS

Official Title

CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy

Who Can Participate

Age: 45Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary written informed consent obtained prior to any study-related procedures
  • Ability to read, understand, and sign the Informed Consent Form and reliably complete required study documents
  • Willingness to undergo medical intervention, including genetic therapy, and to comply with the visit schedule and all study procedures
  • Commitment to maintain a stable medication and supplement regimen throughout the study, with no initiation of new medications, supplements, or performance-enhancing substances unless approved by the Investigator
  • Men and women aged 45-75 years
  • Body mass index (BMI) between 17.0 and 30.0 kg/m8 at screening
  • Evidence of age-related physical decline or sedentary lifestyle defined as:
  • <150 minutes/week of moderate-intensity activity, or
  • <75 minutes/week of vigorous activity, or
  • <600 MET-minutes/week, or
  • Clinical Frailty Scale (CFS) score 3-6
  • Active Prospera ZEDE eResidency or Physical Residency
  • Stable comorbid conditions for at least 3 months prior to screening
  • Postmenopausal status (women)
  • Willingness to use reliable contraception for 6 months following therapy
  • Low or undetectable antibody titers to AAV9 (1:100 by ELISA)
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or intent to become pregnant; premenopausal status (unless 12 months amenorrhea or FSH 30 IU/L)
  • History of alcohol or drug abuse within 1 year of study entry
  • Initiation of prohibited medications, supplements, or interventions during the study period that may confound efficacy or safety assessments
  • Active malignancy or history of malignancy
  • Strong family history of cancer in first-degree relatives (2 or more relatives diagnosed <60 years)
  • Known hereditary cancer syndrome without genetic counseling clearance
  • History of stroke, transient ischemic attack, myocardial infarction, unstable angina, or coronary artery disease
  • Significant atherosclerotic disease or prior coronary procedures
  • History or current diagnosis of heart failure or uncontrolled hypertension
  • Left ventricular ejection fraction <50%, QTc ≥480 ms, or severe valvular heart disease
  • Ventricular arrhythmias requiring treatment or implantable cardioverter-defibrillator
  • Presence of pacemaker or persistent left bundle branch block
  • Known cardiomyopathy or significant left ventricular hypertrophy
  • History of venous thromboembolism or recurrent thrombosis
  • Strong family history of venous or arterial thrombosis at a young age
  • History of recurrent pregnancy loss or severe obstetric complications
  • High-degree myopia or pathological myopia without clearance
  • History of retinal detachment, vitreous hemorrhage, or retinal vascular disease
  • Use of systemic anti-VEGF therapy
  • Current use of prohibited medications or supplements
  • Fasting plasma glucose ≥6.0 mmol/L or HbA1c ≥6.5% at screening
  • Known diabetes mellitus
  • History of peptic ulcer disease within 12 months
  • Known osteoporosis
  • Severe pulmonary disease or advanced renal disease
  • History of liver disease or active hepatitis
  • Neurodegenerative or neuromuscular disorders
  • Psychiatric or movement disorders impairing participation
  • History of drug-induced myopathy or rhabdomyolysis
  • Elevated creatine kinase at screening
  • Autoimmune diseases requiring immunosuppression
  • Recent infection, fever, or live vaccines
  • Active hepatitis B, hepatitis C, HIV, or tuberculosis
  • Active herpesvirus infection
  • Low platelet count or active anticoagulation
  • Known coagulation disorders
  • Severe physical functional limitation
  • Prior exposure to any AAV gene therapy or investigational drug within 90 days
  • Participation in another clinical trial within 90 days
  • Known hypersensitivity to study products or immunosuppressive agents
  • Life expectancy less than 6 months
  • Any condition posing undue risk or interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

GARM

Coxen Hole, Bay Islands, Honduras, 34101

Actively Recruiting

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Research Team

I

Ivan Morgunov

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

3

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