NCT03458429
Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals
Enrolling by Invitation
PHASE1Ages 55–95InterventionalTreatmentDipnarine MaharajInvestigator-initiated
~30 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:GMFFP
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events
Measured over 24 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Dipnarine Maharaj · PRINCIPAL_INVESTIGATOR · South Florida Bone Marrow/Stem Cell Transplant Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Provide written informed consent.
Be aged between 55-95 years.
Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a score of 4-7 on the Clinical Frailty Scale (Appendix 1) and/or Have an abnormal Immune Risk Profile (IRP)
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 neutrophil antibody test.
Have a negative Human Leukocyte Antigen (HLA) Class I and II antibody test.
Have Cytomegalovirus (CMV) negative or positive sero-testing completed.
Have a life expectancy of at least 24 months as judged by the PI at the time of consent.
Have less than 4 weeks since prior medical therapy, radiation therapy, and/or surgery
Have adequate organ function including:
Exclusion
Have a score of less than 4 or greater than 7 on the Clinical Frailty Scale or Have a score of less than 4 and a No Immune Risk Profile (IRP)
Have used anti-inflammatory medications within 7 days of study treatment,treated subjects may be re-screened after 14 days
Abnormal clinical values including but not limited to:
Be an organ transplant recipient or have an active listing (or expected future listing) for transplant of any organ.
Have a documented intolerance to plasma or its components, or prior intolerance to intravenous fluids.
Have known serum antibodies to plasma proteins, such as haptoglobin, Complement Component (C3/C4), or alpha-1-antitrypsin.
Previous plasma transfusion within 30 days of signing informed consent.
Serious comorbid illness including, but not limited to:
No vascular access
Pregnant or nursing female
Recent ( less than 24 months) history of drug or alcohol abuse
Current participation in an investigational therapeutic or medical device trial
Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial.
Recent use (within 30 days) of immunosuppressive agents
Inability to perform any assessments or relevant procedures required for the study or to give informed consent
What this trial measures
- Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events24 months
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 be assessed throughout the duration of treatment. After the one-year treatment period, participants will complete follow-up assessments every 3 months for 1 year.