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.
S.LAB (SOLOWAYS)
Lead sponsor
Center for New Medical Technologies, Novosibirsk, Russia
Collaborator