Status:
NOT_YET_RECRUITING
Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
Lead Sponsor:
S.LAB (SOLOWAYS)
Collaborating Sponsors:
Center for New Medical Technologies, Novosibirsk, Russia
Conditions:
Aging
Eligibility:
All Genders
45-65 years
Phase:
NA
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 ag...
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,...
Eligibility Criteria
Inclusion
- . 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06877377
Start Date
September 1 2025
End Date
March 1 2026
Last Update
July 20 2025
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