Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals

Part of paid clinical trials in Boynton Beach, Florida.

Sponsor
Dipnarine Maharaj
Study ID
NCT03458429
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Frailty

Eligibility Criteria

Sex
ALL
Age
55 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • GMFFP — DRUG
    Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma

Study Details

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.

Key Dates

Start date
Feb 5, 2018
Status verified
Apr 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Frail, older subjects
    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.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
South Florida Bone Marrow/Stem Cell Transplant Institute DBA Maharaj Institute of Immune Regenerative MedicineBoynton BeachFlorida33437-

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By research site
South Florida Bone Marrow/Stem Cell Transplant Institute DBA Maharaj Institute of Immune Regenerative Medicine· Boynton Beach, FL

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