Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients

Launched by S.LAB (SOLOWAYS) · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment that uses a special technology called hDNAgr to help improve the health of blood and bone marrow in adults aged 45 to 65. The goal is to see if this treatment can safely fix some of the damage in our genes that happens as we age, possibly making our bodies function better and even lowering our biological age. The study will involve 60 participants, who will be divided into two groups: one will receive the treatment and the other will get a placebo (a treatment that has no active ingredients). Over six months, researchers will closely monitor participants to check for any side effects and measure various health indicators.

To be eligible for this study, participants need to be between 45 and 65 years old and should not have serious ongoing health issues or a history of cancer in the last five years. They also need to be willing to attend all scheduled visits and follow the study's guidelines. Those who are pregnant, have certain immune disorders, or are taking specific medications will not be able to participate. If you join this trial, you can expect multiple visits over six months where your health will be regularly checked, and you'll be helping researchers learn more about aging and potential new treatments.

Gender

ALL

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