Clinical trial NCT06877377: Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
Official title: A Pilot Randomized, Blinded, Placebo-controlled Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Keywords: DNAgr-technology
haemopoesis
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
First posted: 2025-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This pilot study, titled "Pilot Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Natural Genome Reconstruction Technology in Hematopoietic Stem Cells in Adult Patients," investigates the use of hDNAgr technology-which involves the administration of fragmented therapeutic double-stranded DNA-to achieve natural genomic reconstruction in hematopoietic stem cells. The hypothesis is that this intervention will lead to a safe and controlled correction of damaged genomic regions and telomere elongation, thereby improving hematopoietic parameters (evidenced by restored polyclonality and enhanced reparative potential) and promoting overall rejuvenation of the blood and bone marrow, with the potential to reduce the patient's biological age. The primary endpoint is the safety and tolerability of the therapy, determined by the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) over the study period. Secondary endpoints include changes in telomere length (using methods like Q-FISH or qPCR), detailed hematological assessments (hemoglobin levels, counts of erythrocytes, leukocytes, platelets, differential leukocyte analysis, and CD34⁺ cell counts), evaluation of biomarkers of aging and systemic inflammation (such as IL-6, CRP, and TNF-α), functional health assessments (e.g., via the SF-36 scale), and preliminary measures of biological age (including epigenetic clocks). Eligible participants are men and women aged 45-65 who have no decompensated chronic diseases, no history of malignancies in the past 5 years, and who provide informed consent and adhere to study protocols. Exclusion criteria include pregnancy, lactation, plans for pregnancy during the study, active immune deficiencies, decompensated cardiovascular/hepatic/renal conditions, recent use of immunosuppressive or chemotherapeutic agents, substance dependency, and participation in other clinical trials within 30 days of enrollment. The study protocol includes an initial screening (Visit 0), baseline randomization and measurements (Visit 1, Day 0), interim visits at approximately Days 14, 28, 60, and 90, and a final evaluation at Day 180. With 60 participants randomized equally between the hDNAgr and placebo groups, this 6-month pilot trial is designed to generate primary data on safety, tolerability, and preliminary efficacy, thereby setting the stage for future phase II/III studies and potential expansion of indications.

Eligibility criteria: Inclusion Criteria:

* . 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.

Exclusion Criteria:

* 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.
* Participation in other clinical trials 30 days before inclusion or planned participation during this study.
* Observation plan, duration of Follow-Up and number of visits

Primary outcomes:
measure: Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy
timeFrame: 180 days
Secondary outcomes:
measure: Change in Telomere Length
timeFrame: 180 days
measure: Hemoglobin Level (g/dL)
timeFrame: 180 days
measure: Red Blood Cell (RBC) Count (×10^12/L)
timeFrame: 180 days
measure: White Blood Cell (WBC) Count (×10^9/L)
timeFrame: 180 days
measure: WBC Differential (%)
timeFrame: 180 days
measure: Platelet Count (×10^9/L)
timeFrame: 180 days
measure: CD34⁺ Hematopoietic Stem Cell Count (cells/µL)
timeFrame: 180 days
measure: Preliminary Biological Age Evaluation
timeFrame: 180 days
measure: 36-Item Short Form Health Survey (SF-36) Score
timeFrame: 180 days
measure: Interleukin-6 (IL-6) Level (pg/mL)
timeFrame: 180 days
measure: C-Reactive Protein (CRP) Level (mg/L)
timeFrame: 180 days
measure: Tumor Necrosis Factor Alpha (TNF-α) Level (pg/mL)
timeFrame: 180 days
Other outcomes:
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