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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events
Secondary outcome measures
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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dipnarine MaharajLead Sponsor
1 Previous Clinical Trials
29 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify to participate in this medical research?

"Eligible patients for this trial must have frailty and be between 55 and 95 years of age. The study is hoping to enroll around 30 individuals total."

Answered by AI

Are there other examples of GMFFP being tested in a controlled setting?

"Out of the 168 ongoing trials studying GMFFP, 37 are in Phase 3. Although most of these investigations into GMFFP are based out of Saint Louis, Missouri, there are actually 4,670 trial locations for this potential treatment."

Answered by AI

Are recruitment efforts for this research still ongoing?

"This research is not currently looking for test subjects. The trial was first announced on February 5th, 2018 and the most recent update was on May 5th, 2022. There are other options available; as of right now, there are 154 clinical trials actively admitting patients with frailty and 168 trials for GMFFP that need participants."

Answered by AI

What are some conditions that GMFFP has been shown to improve?

"Febrile neutropenia, neutropenia, and infection can all be treated by using GMFFP."

Answered by AI

Does this research project welcome young adults as participants?

"Patients who meet the age requirement of 55 to 95 years old are eligible for this clinical trial. In contrast, there are 85 trials aimed at people below 18 and 255 for senior citizens."

Answered by AI
~9 spots leftby Dec 2026