{"type":"trials","record":{"id":472,"source_id":"clinicaltrials-gov","external_id":"NCT03458429","title":"Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals","brief_summary":"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.","overall_status":"Enrolling By Invitation","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Dipnarine Maharaj","enrollment":30,"countries":["United States"],"start_date":"2018-02-05","completion_date":"2030-12-30","last_update_date":"2026-05-01","source_url":"https://clinicaltrials.gov/study/NCT03458429","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:04.929625+00:00","last_seen_at":"2026-09-25T06:30:28.369+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"55 Years to 95 Years","comparator":null,"organization":"South Florida Bone Marrow/Stem Cell Transplant Institute","interventions":["GMFFP"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Immune Risk Profile (IRP) — 12 and…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing cognitive function (MME) — 12 and…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing quality of life (OPQOL-35) — 12 an…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Frailty Index (FI) — 12 and 24 mon…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Frailty","GMFFP"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:30:29.928011+00:00","duplicate_cluster_key":"id:nct03458429","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-02-05 to 2030-12-30","comparator":null,"confidence":"structured-source","population":"ALL · 55 Years to 95 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:30:28.379Z","intervention":["GMFFP"],"participants":30,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Immune Risk Profile (IRP) — 12 and…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing cognitive function (MME) — 12 and…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing quality of life (OPQOL-35) — 12 an…","Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Frailty Index (FI) — 12 and 24 mon…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty, frailty index.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/472","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}