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Plasma Therapy

GMFFP Transfusions for Frailty

Phase 1 & 2

Waitlist Available

Research Sponsored by Dipnarine Maharaj

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not be pregnant or nursing while participating in this trial. Both men and women of reproductive potential must agree to use an effective means of birth control while participating in the trial. Women of childbearing potential should have a negative serum pregnancy test before treatment, if not surgically sterile.

Have a negative Human Leukocyte Antigen (HLA) Class I and II antibody test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of 12 monthly transfusions of GMFFP to improve cognitive function, quality of life, and frailty index in older adults.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to plasma transfusion such as allergic reactions, infection risk increase due to donor plasma or complications associated with G-CSF mobilization.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My HLA antibody test is negative.

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I am between 55 and 95 years old.

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It's been less than 4 weeks since my last treatment or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events

Secondary study objectives

Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Frailty Index (FI)

Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Immune Risk Profile (IRP)

Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing cognitive function (MME)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Frail, older subjectsExperimental Treatment1 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.

0 / 4Eligibility criteria met