Aging Clinical Trial
Official title:
Evaluation of Safety and Tolerability of Libella Gene Therapy (LGT) for the Treatment of Aging: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat
many of the age related diseases, including Aging itself.
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 Aging.
Subjects willing to participate 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
1. To determine changes from baseline in hTERT expression, telomerase activity, and
telomere length in cells after treatment with AAV-hTERT.
2. To determine changes from baseline in health and aging-related biomarkers after
treatment with AAV-hTERT.
3. To determine changes from baseline in the immune system after treatment with AAV-hTERT.
4. To determine changes from baseline in physical function measures after treatment with
AAV-hTERT
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