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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
subjects will receive a single LGT (AAV-hTERT) treatment via IV administration
IPS Arcasalud SAS
Zipaquirá, Cundinamarca, Colombia
RECRUITINGIncidence of adverse events
Incidence of serious adverse events and adverse events throughout the study
Time frame: 12 months
hTERT expression and telomerase activity
Change from baseline in telomere length
Time frame: 12 months
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