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

NCT07443826 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Age-related Muscle Decline

Interventions

GENETIC

AAV9-Follistatin gene therapy

One-time intramuscular administration of an adeno-associated virus, serotype 9, (AAV9) vector encoding human follistatin.

GENETIC

VEGF Plasmid

Intramuscular supercoiled plasmid DNA gene therapy encoding vascular endothelial growth factor (VEGF).

Sponsors & Collaborators

  • Global Alliance for Regenerative Medicine

    collaborator OTHER

  • Unlimited Biotechnology LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-09-30
Completion
2028-06-30

Countries

  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443826 on ClinicalTrials.gov