Evaluation of Safety and Tolerability of Libella Gene Therapy for the Treatment of Aging: AAV- hTERT
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|ClinicalTrials.gov Identifier: NCT04133649|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : December 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Aging||Drug: AAV-hTERT||Phase 1|
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.
Primary: Safety and Tolerability
1. Investigate the safety and tolerability of AAV-hTERT by intravenous (IV) administration.
Secondary: Provisional Efficacy
- To determine changes from baseline in hTERT expression, telomerase activity, and telomere length in cells after treatment with AAV-hTERT.
- To determine changes from baseline in health and aging-related biomarkers after treatment with AAV-hTERT.
- To determine changes from baseline in the immune system after treatment with AAV-hTERT.
- To determine changes from baseline in physical function measures after treatment with AAV-hTERT
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Tolerability of Libella Gene Therapy (LGT) for the Treatment of Aging: AAV- hTERT|
|Actual Study Start Date :||October 17, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: subjects treated with LGT
Subjects will be treated with a single IV dose of LGT (AAV-hTERT)
subjects will receive a single LGT (AAV-hTERT) treatment via IV administration
Other Name: LGT
- Incidence of adverse events [ Time Frame: 12 months ]Incidence of serious adverse events and adverse events throughout the study
- hTERT expression and telomerase activity [ Time Frame: 12 months ]Change from baseline in telomere length
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133649
|Contact: Jeff Mathis, PhD||1 785 firstname.lastname@example.org|
|Contact: Osvaldo Martinez-Clark||1 786 email@example.com|
|IPS Arcasalud SAS||Recruiting|
|Zipaquirá, Cundinamarca, Colombia, 250251|
|Contact: Wiston Pernet, MD 57 3006840951 firstname.lastname@example.org|
|Study Chair:||Winston Pernet, MD||IPS Arcaslud SAS|