{"type":"trials","record":{"id":50749,"source_id":"clinicaltrials-gov","external_id":"NCT03169231","title":"Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty","brief_summary":"This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Longeveron Inc.","enrollment":150,"countries":["United States"],"start_date":"2017-07-06","completion_date":"2021-09-30","last_update_date":"2022-03-07","source_url":"https://clinicaltrials.gov/study/NCT03169231","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:40:48.95077+00:00","last_seen_at":"2026-09-25T06:05:08.502+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"70 Years to 85 Years","comparator":"Study Group E","organization":"Longeveron Inc.","interventions":["Longeveron Mesenchymal Stem Cells (LMSCs)","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline in 6 Minute Walk Test (6MWT) compared to placebo — Baseline and 180 days post-infusion","Change in patient reported outcome of overall physical function capacity using the PROMIS-Physical Function-Short Form…","Change in TNF-alpha compared to placebo — 180 days post-infusion"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Aging Frailty","Longeveron Mesenchymal Stem Cells (LMSCs)","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: stem cell.","quality_checked_at":"2026-09-25T06:05:13.559725+00:00","duplicate_cluster_key":"id:nct03169231","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2017-07-06 to 2021-09-30","comparator":"Study Group E","confidence":"structured-source","population":"ALL · 70 Years to 85 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":"2026-09-25T06:05:08.536Z","intervention":["Longeveron Mesenchymal Stem Cells (LMSCs)","Placebo"],"participants":150,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"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":["Change from baseline in 6 Minute Walk Test (6MWT) compared to placebo — Baseline and 180 days post-infusion","Change in patient reported outcome of overall physical function capacity using the PROMIS-Physical Function-Short Form…","Change in TNF-alpha compared to placebo — 180 days post-infusion"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"stem-cells","is_published":true,"match_reasons":["Title contains controlled term: stem cell.","Source terminology contains: stem cell.","Title supplies longevity context: aging, frailty.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Stem cells","slug":"stem-cells"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/50749","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}