drugset / Trial / NCT04110964

Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT

NCT04110964 ↗

Phase 1 Unknown 5 enrolled Libella Gene Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI). This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse the development of the pathology of CLI. It is expected to have a direct consequence on function and quality of life in patients with Peripheral artery disease (PAD); in this case a subgroup of patients with CLI, the worst presentation of PAD.

Timeline

Start
2019-09-26
Primary completion
2020-12
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AAV-hTERT Gene therapy (AAV / viral vector) — Intravenous

Indications