Plasma Transfusion for Aging

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether plasma transfusions from young, healthy male donors can slow or reverse some signs of aging in older adults. Researchers examine changes in biological age indicators, such as DNA and hormone levels, along with improvements in cognitive and physical health. Individuals over 40 who have been on stable medications for at least two months may qualify for this study. The trial includes a series of six plasma transfusions to assess their impact on aging-related health factors. As a Phase 1, Phase 2 trial, it aims to understand the treatment's effects and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that plasma transfusions are likely to be safe for humans?

Research shows that plasma transfusions are generally safe, but some risks exist. Studies indicate that allergic reactions are the most common side effect, usually mild, causing symptoms like itching or a rash. Severe allergic reactions can occur, though they are rare.

In some cases, plasma transfusions have been linked to more serious problems, such as organ failure or breathing issues, primarily in trauma patients rather than healthy individuals. Overall, plasma is considered a safe blood product.

Understanding these risks is important when considering participation in a clinical trial. Always consult with the medical team to understand how these risks might affect you. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for age-related conditions, which often include medications targeting symptoms or lifestyle changes, plasma transfusion therapy is unique because it uses the plasma from younger individuals to potentially rejuvenate older ones. This approach focuses on reversing markers of aging at a cellular level, using the unique proteins and factors present in young plasma. Researchers are excited because this method could directly address the underlying biological processes of aging, rather than just managing its symptoms.

What evidence suggests that plasma transfusion might be an effective treatment for biological aging?

Research shows that plasma transfusions, which participants in this trial will receive, can be beneficial in various medical situations. Studies have found that plasma infusions can improve certain blood markers and reduce complications in very sick patients. Although not directly linked to aging, these findings suggest that plasma transfusions might positively affect biological markers related to aging. The idea is that young plasma could help improve factors like DNA methylation, which influences gene function, and other health indicators in older people. While data on using plasma transfusions to reverse aging is limited, these early signs make it a promising area for further research. ^{6 7 8 9 10}

Who Is on the Research Team?

Chandra s duggirala

Principal Investigator

Fountain Labs, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Plasma Transfusion

How Is the Trial Designed?

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+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/trf.17835

A review and analysis of outcomes in randomized clinical ... We reviewed and analyzed outcomes in randomized controlled trials (RCTs) to provide a methodology for describing and classifying outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1473050223000745/pdf

Plasma transfusion in critically Ill patients with abnormal ... The primary outcome was the occurrence of postprocedural bleeding complications. Secondary outcomes included transfusion of red blood cells within 24 h of the ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2784420

Evaluating the Cost-effectiveness of Prehospital Plasma ... This secondary analysis evaluates the cost-effectiveness of prehospital thawed plasma transfusion in trauma patients with hemorrhagic shock

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666795/

The efficacy and safety of pre-hospital plasma in patients at ... Plasma infusion was significantly better in the total 24-h volume of PRBC units (P = 0.03) and INR on arrival (P = 0.009). For all other ...

5. tsaco.bmj.com tsaco.bmj.com/content/9/1/e001310.full

Is there a need for fresh frozen plasma and platelet ... Patients administered CR had a lower rate of any complications developed (15% vs 26%) (p=0.01), ARDS (3% vs 5%) (p=0.03), and AKI (8% vs 11%) (p ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3356109/

Adverse Effects of Plasma Transfusion - PMC In trauma patients who survive their initial injury, one study showed a 2.1% and 2.5% increased risk of multi-organ failure (MOF) and acute respiratory ...

7. isbtweb.org isbtweb.org/resources/educational-modules-on-clinical-use-of-blood/plasma-transfusion.html

Plasma Transfusion | The International Society of Blood ... RISKS OF PLASMA TRANSFUSION. Allergic reactions can occur following plasma transfusion. Usually these are mild reactions but occasionally severe allergic ...

8. who.int who.int/news-room/fact-sheets/detail/blood-safety-and-availability

Blood safety and availability Blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood.

9. cdc.gov cdc.gov/blood-safety/about/index.html

Blood Safety Basics The most common adverse reactions from blood transfusions are allergic and febrile reactions, which make up over half of all adverse reactions ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1473-0502(10)00149-7

Non-infectious serious hazards in plasma transfusion Plasma is a safe blood product, but there are adverse events reported to hemovigilance systems attributed to plasma transfusion (Table 1). Inappropriate and ...