Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects

(RESET-YOUTH Trial)

Overseen By Chandra s Duggirala, MBBS, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Chandra Duggirala

Must not be taking: Anticoagulants, others

Disqualifiers: Dementia, Cardiovascular, Psychiatric, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 months

2120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that your medications be stable for 2 months before joining, so you may not need to stop them if they have been stable. However, you cannot use anti-coagulant therapy, and daily aspirin is allowed if the dose is stable for 30 days before joining.

What data supports the effectiveness of plasma transfusion as a treatment?

Plasma transfusion is effective in treating complex bleeding disorders, especially in cases of massive transfusion, certain blood clotting disorders, and liver disease. It is also the preferred treatment for conditions like thrombotic-thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS). Additionally, solvent/detergent-treated plasma is associated with fewer allergic reactions compared to fresh frozen plasma. ^{1 2 3 4 5}

Is plasma transfusion generally safe for humans?

Plasma transfusion can cause some adverse reactions, such as allergic reactions, lung injury, and fluid overload, but these are often not severe and can be treated. The risk of infection is very low due to safety measures, and most adverse effects are manageable in clinical practice. ^{6 7 8 9 10}

How does plasma transfusion differ from other treatments for bleeding disorders?

Plasma transfusion is unique because it involves administering plasma, which contains all the soluble coagulation factors, to help stop or prevent bleeding. Unlike other treatments, plasma transfusion can be used in emergency situations when clotting test results are unavailable, and it is particularly indicated for complex bleeding conditions like massive transfusion or liver disease. ^{1 3 11 12 13}

What is the purpose of this trial?

This trial studies the effects of regular treatments using plasma from young healthy male donors on patients older than 40 years. The goal is to see if the young plasma can rejuvenate the body and improve functions like cognition, muscle strength, and organ health.

Research Team

Chandra s duggirala

Principal Investigator

Fountain Labs, Inc.

Eligibility Criteria

Inclusion Criteria

Age > 40.

Stable medications for 2 months prior to Screening.

Signed and dated written informed consent obtained from the subject in accordance with local Institutional Review Board regulations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Monthly transfusions of young healthy male donor plasma for 6 months

6 months

6 visits (in-person, monthly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Plasma Transfusion

Participant Groups

Group I: Plasma Transfusion Experimental Treatment 1 Intervention

Plasma Transfusions with 2 units of plasma per dose, for a total of 6 doses

Who Is Running the Clinical Trial?

Chandra Duggirala

Lead Sponsor

Trials

1

Recruited

2,100+

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Recommendations for the use of therapeutic plasma. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Association between perioperative plasma transfusion and in-hospital mortality in patients undergoing surgeries without massive transfusion: A nationwide retrospective cohort study. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Transition from fresh frozen plasma to solvent/detergent plasma in the Netherlands: comparing clinical use and transfusion reaction risks. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Indications for early plasma transfusion and its optimal use following trauma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Male-predominant plasma transfusion strategy for preventing transfusion-related acute lung injury: a systematic review. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Determining the true incidence of acute transfusion reactions: Active surveillance at a specialized liver center. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Risks and side effects of therapy with plasma and plasma fractions. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse effects of plasma transfusion. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Analysis of Acute Transfusion Reactions and Their Occurrence Times. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Non-infectious serious hazards in plasma transfusion. [2020]

11. France pubmed.ncbi.nlm.nih.gov

[Non-cardiogenic pulmonary edema after transfusion of plasma containing an anti-HLA-B21 antibody]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Plasma and Plasma Protein Product Transfusion: A Canadian Blood Services Centre for Innovation Symposium. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Results of a quality-control study of lyophilized pooled plasmas which have been 'virally inactivated' using a solvent detergent method (modified Horowitz procedure). [2012]