Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
Sponsor: S.LAB (SOLOWAYS)
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.
Official title: A Pilot Randomized, Blinded, Placebo-controlled Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
Key Details
Gender
All
Age Range
45 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-01
Completion Date
2026-03-01
Last Updated
2025-07-20
Healthy Volunteers
Yes
Conditions
Interventions
hDNAgr Therapy
A novel investigational therapy that uses fragmented therapeutic double-stranded DNA, designed to correct or replace locally damaged genomic regions in hematopoietic stem cells and elongate telomeres. The hDNAgr therapy is administered according to the study protocol schedule (Visits at Day 0, 14, 28, 60, 90, and 180), with blood draws and safety evaluations at each time point to assess hematological parameters, telomere length, and potential impacts on biological aging.
Placebo
An inactive formulation identical in appearance to the hDNAgr therapy but lacking the active DNA fragments. It is administered under the same schedule and conditions as the experimental intervention to maintain blinding and enable comparison of safety and efficacy outcomes.