RecruitingPhase 1/2

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

Honduras12 participantsStarted 2026-03-31

Plain-language summary

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.

Who can participate

Age range

45 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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/m² 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) Exclusion Criteria: * Pregnancy, breastfeeding, or intent to become pregnant; premenopausal status (unless ≥12 months amenorrhea or FSH ≥30 IU/L) * Subjects who have a history of alcohol or drug abuse within 1 year of study entry * Initiation of prohibited medications, supplements, or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs)

Timeframe: Day 1 through Day 90 after AAV administration

Number of participants with dose-limiting toxicities (DLTs)

Timeframe: Day 1 through Day 21 after AAV administration

Trial details

NCT IDNCT07443826

SponsorUnlimited Biotechnology LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Ivan Morgunov

+31623454906 ivan@unlimit.bio

View on ClinicalTrials.gov More Age-related Muscle Decline trials