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

NCT06877377 | Not Yet Recruiting

• 1 other identifier: SW025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

DNAgr-technology; haemopoesis

Outcome Measures

Primary Outcomes (1)

• Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy

  The primary endpoint is the frequency and severity of adverse events (AEs) and serious adverse events (SAEs) observed in participants receiving hDNAgr therapy versus placebo. Safety will be assessed at each study visit through medical examinations, laboratory evaluations, and participant-reported outcomes.

  180 days

Secondary Outcomes (12)

• Change in Telomere Length

  180 days

• Hemoglobin Level (g/dL)

  180 days

• Red Blood Cell (RBC) Count (×10^12/L)

  180 days

• White Blood Cell (WBC) Count (×10^9/L)

  180 days

• WBC Differential (%)

  180 days

Study Arms (2)

Experimental: hDNAgr Technology

EXPERIMENTAL

Participants in this arm will receive the hDNAgr therapy, a novel approach using fragmented double-stranded DNA designed to correct damaged genomic regions in hematopoietic stem cells and elongate telomeres. The treatment is administered according to the protocol schedule (Visits at Day 0, 14, 28, 60, 90, and 180), and all relevant safety and efficacy parameters (adverse events, hematological markers, telomere length, and potential aging biomarkers) are assessed throughout the 6-month follow-up period.

Biological: hDNAgr Therapy

Placebo Comparator: Inactive Formulation

PLACEBO COMPARATOR

Participants in this arm will receive an inactive placebo formulation, identical in appearance to the hDNAgr therapy but lacking the active DNA fragments. This ensures blinding for both subjects and investigators. The same follow-up schedule (Visits at Day 0, 14, 28, 60, 90, and 180) and assessments (adverse events, hematological markers, telomere length, and aging biomarkers) are conducted, enabling direct comparison to the experimental arm.

Other: Placebo

Interventions

hDNAgr Therapy BIOLOGICAL

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.

Experimental: hDNAgr Technology

Placebo OTHER

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.

Placebo Comparator: Inactive Formulation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 45 to 65 years inclusive (optimal age range for a pilot study of the effect on aging processes).
• Confirmed absence of serious chronic diseases in the decompensation stage (based on the results of a standard clinical and laboratory examination).
• No history of malignant neoplasms over the past 5 years. Written informed consent to participate in the study. Willingness to comply with the study protocol, including attending all scheduled visits and undergoing the required diagnostic procedures.

You may not qualify if:

• Pregnancy, lactation, or planning a pregnancy during the study.
• The presence of immunodeficiency states (HIV infection, severe autoimmune diseases, etc.) in the acute stage.
• Decompensated cardiovascular, hepatic, renal pathologies (a conclusion from a therapist or a specialized specialist is required).
• Take immunosuppressants, corticosteroids or chemotherapeutic drugs within 3 months before screening.
• Alcohol or drug addiction, confirmed by medical documents or identified during screening.
• Observation plan, duration of Follow-Up and number of visits

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Central Study Contacts

Evgeny A Pokushalov, Professor

CONTACT

+79628316017; dayshadoff@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share