GMFFP Transfusions for Frailty

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dipnarine Maharaj

Must not be taking: Anti-inflammatories, Immunosuppressants

Disqualifiers: Organ transplant, HIV, Cancer, others

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

Compensation: Varies

Number of Visits: 16

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called GMFFP, which involves transfusions of plasma from young, healthy donors. The aim is to determine if these monthly transfusions are safe and improve health and quality of life for older adults experiencing frailty and unhealthy aging. It suits individuals aged 55 to 95 who feel weak or frail and face immune system challenges. Participants will receive 12 monthly treatments and be monitored for a year to assess outcomes. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring 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 does not specify if you need to stop taking your current medications, but you cannot have used anti-inflammatory medications within 7 days of the study treatment. You also cannot have used immunosuppressive agents within 30 days before the trial.

Is there any evidence suggesting that GMFFP is likely to be safe for humans?

Research has shown that Granulocyte-Colony Stimulating Factor (G-CSF), a key component of the GMFFP treatment, has received FDA approval for other uses, such as aiding in stem cell collection. This approval indicates that G-CSF is generally considered safe for humans. However, limited information exists about GMFFP transfusions specifically. The current study is in its early stages, focusing primarily on the safety and tolerability of the treatment for older, frail individuals. Early-phase trials typically involve fewer participants, so while initial results may appear promising, further research is necessary to confirm safety in a larger group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GMFFP is unique because it uses Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma to potentially improve frailty in older adults. Unlike current treatments that might focus on physical therapy or nutritional supplementation, GMFFP introduces a biological component that could enhance the body's natural regenerative processes. Researchers are excited about this approach because it targets frailty at a cellular level, possibly offering a more direct and effective way to improve strength and vitality in frail, older individuals.

What evidence suggests that GMFFP transfusions might be an effective treatment for frailty?

Research suggests that Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma (GMFFP) might aid frailty and weak immune systems in older adults. This trial will treat frail, older subjects with GMFFP. G-CSF, a key component of GMFFP, is already approved and has shown promise in boosting immune function. Recent studies with similar treatments, such as stem cells, have shown positive results in slowing or reversing aging, including reducing frailty. Researchers are investigating GMFFP's potential to improve memory, quality of life, and overall health in older people, with early results indicating positive effects. Overall, there is hope that GMFFP can support healthier aging in frail individuals. ^{1 2 3 4 5}

Who Is on the Research Team?

Dipnarine Maharaj

Principal Investigator

South Florida Bone Marrow/Stem Cell Transplant Institute

Are You a Good Fit for This Trial?

This trial is for individuals aged 55-95 showing signs of frailty or having an abnormal immune profile. They must not be pregnant, agree to birth control if applicable, and have a life expectancy over 24 months. Participants need normal blood counts and organ function tests, and can't join if they've had recent medical treatments.

Inclusion Criteria

I am not pregnant or nursing and agree to use birth control during the trial.

Your test for neutrophil antibodies is negative.

My HLA antibody test is negative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 once monthly transfusions of GMFFP from young, healthy donors

12 months

12 visits (in-person, monthly)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments every 3 months

12 months

4 visits (in-person, quarterly)

What Are the Treatments Tested in This Trial?

Interventions

• GMFFP

Trial Overview The study is testing the safety and effectiveness of GMFFP transfusions from young donors in older adults with frailty. Over one year, participants will receive monthly transfusions aimed at improving their immune function, cognitive health, quality of life, and frailty status.

How Is the Trial Designed?

Group I: Frail, older subjects Experimental Treatment 1 Intervention

Treated subjects are the frail, older subjects who will be treated with Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma (GMFFP) in this protocol.

Who Is Running the Clinical Trial?

Dipnarine Maharaj

Lead Sponsor

Trials

2

Recruited

60+

Citations

1. regenerativefoundation.com regenerativefoundation.com/study/

Clinical Study - Regenerative Foundation The secondary objective is to determine the efficacy in older, frail individuals of 12, once monthly transfusions of GMFFP (Granulocyte – Colony Stimulating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10116573/

Recent clinical trials with stem cells to slow or reverse ... Several clinical trials have been launched in order to evaluate the efficacy of mesenchymal stem cell interventions to slow or reverse normal aging processes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12159420/

Looking at frailty and intrinsic capacity through a geroscience ... On 22 March 2023, the ICFSR Task Force met to discuss potential bridges of geroscience with intrinsic capacity and frailty research. The main topics discussed ...

4. researchgate.net researchgate.net/publication/369878449_Recent_clinical_trials_with_stem_cells_to_slow_or_reverse_normal_aging_processes

Recent clinical trials with stem cells to slow or reverse ... With regard to physical frailty, positive results have been obtained in phase II studies with intravenous Lomecel-B (an allogeneic bone marrow stem cell ...

5. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT03458429?keyword=%22G-CSF%22

Safety, Efficacy of FFP From Healthy Donors to ... Granulocyte Colony Stimulating Factor (G-CSF) has been approved by the FDA ... effective treatment for frailty and immune dysfunction in older individuals.