AgingNCT06877377
Study of the Safety and Efficacy of Natural Genome Reconstruction Technology of Hematopoietic Stem Cells in Adult Patients
A study testing hDNAgr Therapy in people with Aging, run by S.LAB (SOLOWAYS).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- hDNAgr Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Aging
- Being tested
- hDNAgr Therapy, Placebo
- Keywords
- DNAgr-technology, haemopoesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hDNAgr TherapyBiological
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: hDNAgr Technology | Experimental | Participants in this arm will receive the hDNAgr therapy, a novel approach using fragmented double-stranded DNA designed to correct damaged genomic regions in hematopoietic stem cells and elongate telomeres. The treatment is administered according to the protocol schedule (Visits at Day 0, 14, 28, 60, 90, and 180), and all relevant safety and efficacy parameters (adverse events, hematological markers, telomere length, and potential aging biomarkers) are assessed throughout the 6-month follow-up period. Receives: Biological: hDNAgr Therapy |
| Placebo Comparator: Inactive Formulation | Placebo comparator | Participants in this arm will receive an inactive placebo formulation, identical in appearance to the hDNAgr therapy but lacking the active DNA fragments. This ensures blinding for both subjects and investigators. The same follow-up schedule (Visits at Day 0, 14, 28, 60, 90, and 180) and assessments (adverse events, hematological markers, telomere length, and aging biomarkers) are conducted, enabling direct comparison to the experimental arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy
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.
Measured: 180 days
Secondary outcomes (12)
Change in Telomere Length
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.
Measured: 180 days
Hemoglobin Level (g/dL)
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.
Measured: 180 days
Red Blood Cell (RBC) Count (×10^12/L)
RBC count (×10^12 per liter) measured in peripheral blood using automated counters to evaluate overall erythropoietic activity and red cell status.
Measured: 180 days
White Blood Cell (WBC) Count (×10^9/L)
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.
Measured: 180 days
WBC Differential (%)
Distribution percentages of neutrophils, lymphocytes, monocytes, eosinophils, and basophils in peripheral blood. This measure helps to evaluate shifts in immune cell subtypes over time.
Measured: 180 days
Platelet Count (×10^9/L)
Platelet count (×10^9 per liter) measured in peripheral blood with an automated analyzer. This outcome assesses platelet production and turnover.
Measured: 180 days
CD34⁺ Hematopoietic Stem Cell Count (cells/µL)
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.
Measured: 180 days
Preliminary Biological Age Evaluation
Assessment of biological age via methods such as epigenetic clocks and/or relevant functional tests to gauge any potential "rejuvenation" effect of the therapy.
Measured: 180 days
36-Item Short Form Health Survey (SF-36) Score
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.
Measured: 180 days
Interleukin-6 (IL-6) Level (pg/mL)
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.
Measured: 180 days
C-Reactive Protein (CRP) Level (mg/L)
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.
Measured: 180 days
Tumor Necrosis Factor Alpha (TNF-α) Level (pg/mL)
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877377
- Sponsor's protocol ID
- SW025
- Status last verified
- Jul 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06877377
- Acronym / sponsor ID
- SW025
- Conditions
- Aging
- Keywords
- DNAgr-technology, haemopoesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: hDNAgr Technology | Experimental | Biological: hDNAgr TherapyParticipants in this arm will receive the hDNAgr therapy, a novel approach using fragmented double-stranded DNA designed to correct damaged genomic regions in hematopoietic stem cells and elongate telomeres. The treatment is administered according to the protocol schedule (Visits at Day 0, 14, 28, 60, 90, and 180), and all relevant safety and efficacy parameters (adverse events, hematological markers, telomere length, and potential aging biomarkers) are assessed throughout the 6-month follow-up period. |
| Placebo Comparator: Inactive Formulation | Placebo comparator | Other: PlaceboParticipants in this arm will receive an inactive placebo formulation, identical in appearance to the hDNAgr therapy but lacking the active DNA fragments. This ensures blinding for both subjects and investigators. The same follow-up schedule (Visits at Day 0, 14, 28, 60, 90, and 180) and assessments (adverse events, hematological markers, telomere length, and aging biomarkers) are conducted, enabling direct comparison to the experimental arm. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- . 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hDNAgr TherapyA 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. | Biological | Experimental: hDNAgr Technology |
| PlaceboAn 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. | Other | Placebo Comparator: Inactive Formulation |
Primary outcome
Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy
Time frame: 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.
12 secondary outcomes
Change in Telomere Length
Time frame: 180 days
Hemoglobin Level (g/dL)
Time frame: 180 days
Red Blood Cell (RBC) Count (×10^12/L)
Time frame: 180 days
White Blood Cell (WBC) Count (×10^9/L)
Time frame: 180 days
WBC Differential (%)
Time frame: 180 days
Platelet Count (×10^9/L)
Time frame: 180 days
CD34⁺ Hematopoietic Stem Cell Count (cells/µL)
Time frame: 180 days
Preliminary Biological Age Evaluation
Time frame: 180 days
36-Item Short Form Health Survey (SF-36) Score
Time frame: 180 days
Interleukin-6 (IL-6) Level (pg/mL)
Time frame: 180 days
C-Reactive Protein (CRP) Level (mg/L)
Time frame: 180 days
Tumor Necrosis Factor Alpha (TNF-α) Level (pg/mL)
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing hDNAgr Therapy in people with Aging, run by S.LAB (SOLOWAYS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeny A Pokushalov, Professor (+79628316017, dayshadoff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Any Treatment-Emergent Adverse Events (Safety and Tolerability) in Male Participants Receiving hDNAgr Therapy (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.