Aging
Conditions
Keywords
DNAgr-technology, haemopoesis
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.
Interventions
BIOLOGICALhDNAgr 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.
OTHERPlacebo
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
Center for New Medical Technologies, Novosibirsk, Russia
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy | 180 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level (g/dL) | 180 days | 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) | 180 days | 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) | 180 days | 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. |
| WBC Differential (%) | 180 days | Distribution percentages of neutrophils, lymphocytes, monocytes, eosinophils, and basophils in peripheral blood. This measure helps to evaluate shifts in immune cell subtypes over time. |
| Platelet Count (×10^9/L) | 180 days | Platelet count (×10\^9 per liter) measured in peripheral blood with an automated analyzer. This outcome assesses platelet production and turnover. |
| Change in Telomere Length | 180 days | 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. |
| Preliminary Biological Age Evaluation | 180 days | Assessment of biological age via methods such as epigenetic clocks and/or relevant functional tests to gauge any potential rejuvenation effect of the therapy. |
| 36-Item Short Form Health Survey (SF-36) Score | 180 days | The SF-36 (Short Form Health Survey) is a 36-item validated questionnaire assessing eight domains of physical and mental health: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems, and Mental Health. Scores for each domain range from 0 to 100, with higher scores indicating better perceived health status. Composite scores (Physical Component Summary and Mental Component Summary) are also reported on a 0-100 scale, where 0 represents the poorest health and 100 represents the best health. |
| Interleukin-6 (IL-6) Level (pg/mL) | 180 days | Serum IL-6 concentrations will be measured in picograms per milliliter (pg/mL) using a validated immunoassay to evaluate changes in systemic inflammation over time. Higher levels may indicate increased inflammatory activity. |
| C-Reactive Protein (CRP) Level (mg/L) | 180 days | CRP will be measured in milligrams per liter (mg/L) to assess the presence and degree of systemic inflammation, with higher levels indicating a more pronounced inflammatory state. |
| Tumor Necrosis Factor Alpha (TNF-α) Level (pg/mL) | 180 days | TNF-α will be measured in picograms per milliliter (pg/mL) via a validated immunoassay to evaluate changes in systemic inflammatory and immune responses over time. |
| CD34⁺ Hematopoietic Stem Cell Count (cells/µL) | 180 days | Absolute count of CD34⁺ progenitor cells (cells/µL) in peripheral blood, typically assessed via flow cytometry. Helps gauge changes in hematopoietic stem cell populations over the course of therapy. |
Contacts
Primary ContactEvgeny A Pokushalov, Professor
Outcome results
None listed