Safety and Efficacy of Klotho and Follistatin Gene Therapy
NCT ID: NCT07285629
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-12-16
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intervention with Cognitive/Health battery before and after
This arm includes cognitive and health battery pre- and post-intervention of the gene therapy
Follistatin and klotho gene therapy
Injection of nonviral plasmid-delivered follistatin and klotho gene therapy
Interventions
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Follistatin and klotho gene therapy
Injection of nonviral plasmid-delivered follistatin and klotho gene therapy
Eligibility Criteria
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Inclusion Criteria
* General good health
* Willing to comply with all study-related procedures and visits
* Participant is open to morphological change
* If female, participant agrees to maintain contraception
* If female, participant agrees to take a pregnancy test
* If female, participant agrees to a pregnancy waiver
Exclusion Criteria
* History of cancer, autoimmune disease, or chronic kidney/liver disease
* Use of immunosuppressive therapy
* Pregnant or breastfeeding
* Women of childbearing potential who are unwilling or unable to use effective contraception for the duration of the study.
* Regular use of NMDA (N-methyl-D-aspartate) antagonists (i.e., memantine, ketamine, etc.)
* Regular use of antiplatelet medications (i.e., aspirin)
* Any medical or psychiatric condition that could interfere with participation or pose safety concerns
* Unwilling or unable to provide informed consent
50 Years
80 Years
ALL
Yes
Sponsors
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Minicircle
INDUSTRY
Responsible Party
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Locations
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Apeiron Center
Austin, Texas, United States
Global Alliance of Regenerative Medicine (GARM) Clinic
Roatán, Bay Islands, Honduras
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GIFIRB202507313
Identifier Type: -
Identifier Source: org_study_id
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