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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

1. Primary Objective To determine the safety and tolerability of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), given to older, frail individuals who are at risk due to unhealthy aging and who will then have a subsequent 12-month follow-up period. 2. Secondary Objective To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve the Immune Risk Profile, ("IRP"), cognitive function (MME), quality of life (OPQOL-35), Frailty Index ("FI"), associated with unhealthy aging in the treated subjects.

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.

How does the GMFFP treatment for frailty differ from other treatments?

GMFFP transfusions for frailty are unique because they involve the use of fresh frozen plasma (FFP), which is not a standard treatment for frailty. This approach may offer a novel way to address frailty by potentially providing essential proteins and factors that could improve overall health and resilience. ^{1 2 3 4 5}

Research Team

Dipnarine Maharaj

Principal Investigator

South Florida Bone Marrow/Stem Cell Transplant Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Methylene blue-photoinactivated plasma versus quarantine fresh frozen plasma in thrombotic thrombocytopenic purpura: a multicentric, prospective cohort study. [2013]

2. Australia pubmed.ncbi.nlm.nih.gov

Use of double filtration plasmapheresis for the treatment of acquired thrombocytopenic thrombotic purpura. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Fresh frozen plasma and platelet concentrates may increase plasma anti-diphtheria toxin IgG concentrations: Implications for diphtheria fusion protein therapy. [2021]

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

ADAMTS13 content in plasma-derived factor VIII/von Willebrand factor concentrates. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Solvent/detergent fresh frozen plasma as primary treatment of acute thrombotic thrombocytopenic purpura. [2019]