Clinical Trial

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

Study acronym: CALM-AF-AI
Recruiting Phase 1/2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-24; most recent amendment 2026-07-10.
Status change: Not Yet Recruiting → Recruiting 2026-03-04
Trial Details
NCT Number NCT07443826
Lead Sponsor Unlimited Biotechnology LLC
Collaborators: Global Alliance for Regenerative Medicine
Conditions Age-related Muscle Decline
Enrollment 12 participants
Start Date 2026-06-01
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13