Safety and Efficacy of Klotho and Follistatin Gene Therapy
Start Date
12/16/2025
Completion Date
6/1/2026
Summary
The purpose of this study is to investigate the safety and efficacy of a combination klotho and follistatin gene therapy, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of this gene therapy.
Detailed Description
Healthy participants will take part in cognitive and health testing before and after administration of plasmid-delivered nonviral klotho and follistatin gene therapy. The method of administration will be subcutaneous injection into abdominal fat deposits. Klotho and follistatin plasmid gene therapy have the potential to improve physical function, cognitive function, kidney function, body composition, epigenetic age, and subjective well being. Note that the investigational product will be administered at a site outside of the U.S. which is not under FDA jurisdiction, and only non-treatment pre/post outcome assessments (e.g., cognitive assessments or blood sample collection) occur at the U.S. site.
Eligibility Criteria
Age Range: 50 years to 80 years
Interventions
Follistatin and klotho gene therapy
Conditions
Locations
Apeiron Center
Austin, Texas 78701
United States
Global Alliance of Regenerative Medicine (GARM) Clinic
Roatán, Bay Islands
Honduras