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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 20, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: Jun 1, 2025 to Sep 1, 2025
    • Primary completion date: Nov 1, 2025 to Feb 1, 2026
    • Study completion date: Dec 1, 2025 to Mar 1, 2026
    v3
  2. Primary endpoint revisedv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06877377
Lead Sponsor S.LAB (SOLOWAYS)
Collaborators: Center for New Medical Technologies, Novosibirsk, Russia
Conditions
(from sponsor)		 Aging
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov