Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critical Limb Ischemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 125 years
- Gender
- Both males and females
Description
Patients diagnosed with CLI who meet with the inclusion - exclusion criteria, will be treated with a single dose of LGT delivered intravascularly (IV). Baseline will be performed within 8 weeks of beginning the treatment regimen. The treatment regimen will begin with IV delivery of AAV-hTERT, define...
Patients diagnosed with CLI who meet with the inclusion - exclusion criteria, will be treated with a single dose of LGT delivered intravascularly (IV). Baseline will be performed within 8 weeks of beginning the treatment regimen. The treatment regimen will begin with IV delivery of AAV-hTERT, defined as "Day 0." Safety and efficacy analyses will be conducted at Weeks 1, 4, 13, 26, 39, and 52 post-treatment. Study objectives Primary: Safety and Tolerability 1. Investigate the safety and tolerability of AAV-hTERT by intravenous (IV) administration. Secondary: Provisional Efficacy Investigate LGT's ability to deliver hTERT to human cells and lengthen telomeres. Investigate the effects of lengthening telomeres on CLI. Investigate other benefits provided by lengthening telomeres.
Tracking Information
- NCT #
- NCT04110964
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jorge Ulloa, MD IPS Arcaslud SAS
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