Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients

Summary

This pilot randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of the hDNAgr technology aimed at natural genome reconstruction in hematopoietic stem cells in adults aged 45-65. The study hypothesizes that administering fragmented therapeutic double-stranded DNA will safely correct localized genomic damage-including telomere elongation-enhance hematopoietic function by restoring polyclonality and increasing reparative potential, and ultimately rejuvenate blood and bone marrow to potentially lower the patient's biological age. The primary endpoint is safety and tolerability, assessed by the frequency and severity of adverse events, while secondary endpoints focus on telomere length, hematological parameters, aging and inflammation biomarkers, functional health measures, and preliminary biological age evaluations. Sixty participants (30 in the hDNAgr group and 30 receiving placebo) will be observed over a 6-month period with multiple scheduled visits.

Timeline

Start

2025-09-01

Primary completion

2026-02-01

Completion

2026-03-01

Drugs

Indications