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

NCT06877377 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-20

No results posted yet for this study

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.

Conditions

  • Aging

Interventions

BIOLOGICAL

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.

OTHER

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.

Sponsors & Collaborators

  • Center for New Medical Technologies, Novosibirsk, Russia

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-02-01
Completion
2026-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06877377 on ClinicalTrials.gov