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.
. 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.
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.
Parallel
hDNAgr Therapy
Biological/VaccineA 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
Other interventionAn 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.
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.
Change in Telomere Length
Telomere length in peripheral blood leukocytes will be measured using validated methods (e.g., Q-FISH, qPCR) to assess potential elongation or maintenance over time.
Hemoglobin Level (g/dL)
Hemoglobin concentration (g/dL) measured in peripheral blood. Values will be obtained via standard clinical laboratory methods to assess potential improvements or changes in oxygen-carrying capacity.
Red Blood Cell (RBC) Count (×10^12/L)
RBC count (×10\^12 per liter) measured in peripheral blood using automated counters to evaluate overall erythropoietic activity and red cell status.
White Blood Cell (WBC) Count (×10^9/L)
WBC count (×10\^9 per liter) in peripheral blood determined by automated hematology analyzers to monitor immune cell populations and potential shifts in leukocyte levels.
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S.LAB (SOLOWAYS)
Lead sponsor
Center for New Medical Technologies, Novosibirsk, Russia
Collaborator
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