Libella Gene Therapeutics — World's First Human Telomerase Gene Therapy Trial
Libella Gene Therapeutics conducted the world's first human clinical trial of telomerase gene therapy—a groundbreaking approach to biological aging—through bioaccess®'s clinical network in Latin America.
Study facts
- Sponsor / company: Libella Gene Therapeutics
- Indication / area: Gene Therapy / Longevity
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- World First: Yes
- Trial Type: FIH
- Therapy: Gene therapy
- Target: Biological aging
The challenge
Telomerase gene therapy represents one of the most ambitious frontiers in medicine—directly targeting the biological mechanisms of aging. No regulatory framework in the US or EU was prepared for a human trial of this nature, and Libella needed a pathway to generate the world's first human safety data.
bioaccess® solution
bioaccess® navigated the complex regulatory and ethical landscape in Colombia to secure approval for this unprecedented gene therapy trial. Our team managed gene vector logistics, patient screening, treatment administration, and long-term safety monitoring with specialized biomarker tracking including telomere length measurements.
Results
- World's first human telomerase gene therapy administered
- Safety data collected with extended follow-up monitoring
- Telomere length biomarkers tracked over multiple time points
- Global media coverage generated significant industry attention
- Established a regulatory precedent for aging-related gene therapies in LATAM
Frequently asked
- What did bioaccess® do for Libella Gene Therapeutics?
- bioaccess® navigated the complex regulatory and ethical landscape in Colombia to secure approval for this unprecedented gene therapy trial.
- Where was the Libella Gene Therapeutics First-in-Human (FIH) study run?
- The Libella Gene Therapeutics First-in-Human (FIH) study was executed in Colombia by bioaccess® in the gene therapy / longevity area.
- What was the outcome of the Libella Gene Therapeutics study?
- Reported outcomes for Libella Gene Therapeutics's device: World's first human telomerase gene therapy administered; Safety data collected with extended follow-up monitoring; Telomere length biomarkers tracked over multiple time points.
Run a similar trial: Clinical trials in Colombia
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