{"type":"trials","record":{"id":50762,"source_id":"clinicaltrials-gov","external_id":"NCT02065245","title":"AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery","brief_summary":"The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.","overall_status":"Completed","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Longeveron Inc.","enrollment":65,"countries":["United States"],"start_date":"2014-03-03","completion_date":"2020-10-02","last_update_date":"2021-07-14","source_url":"https://clinicaltrials.gov/study/NCT02065245","editorial_summary":"A registered PHASE1, 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":"CRATUS","age_range":"60 Years to 95 Years","comparator":null,"organization":"Longeveron Inc.","interventions":["Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)","Placebo","Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs) — One Month post infusion","Change in Frailty as Assessed by CHAMPS Questionnaire — At baseline and 6 month follow-up visit.","Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test — At baseline and 6 month follow-up visit.","Change in Slowing of Mobility as Measured by SPPB — At baseline and 6 month follow-up visit.","Change in Weight — At baseline and 6 month follow-up visit.","Change in Diminished Hand Grip Strength — At baseline and 6 month follow-up visit.","Change in Exhaustion as Measured by the MFI Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale. — At baseline and 6 month foll…","Change in Sense of Smell as Measured by UPSIT — At baseline and 6 month follow-up visit.","Death — Up to 12 months.","Change in Ejection Fraction (EF) — At baseline and 6 month follow-up visit.","Change in Inflammatory Markers Levels — At baseline and 6 month follow-up visit.","Change in Inflammatory Markers — At baseline and 6 month follow-up visit.","Change in Inflammatory Marker D-dimer Levels — At baseline and 6 month follow-up visit."],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":true},"controlled_terms":["Frailty","Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)","Placebo","Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)"],"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:nct02065245","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2014-03-03 to 2020-10-02","comparator":null,"confidence":"structured-source","population":"ALL · 60 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":"2026-09-25T06:05:08.538Z","intervention":["Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)","Placebo","Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)"],"participants":65,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs) — One Month post infusion","Change in Frailty as Assessed by CHAMPS Questionnaire — At baseline and 6 month follow-up visit.","Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test — At baseline and 6 month follow-up visit.","Change in Slowing of Mobility as Measured by SPPB — At baseline and 6 month follow-up visit.","Change in Weight — At baseline and 6 month follow-up visit.","Change in Diminished Hand Grip Strength — At baseline and 6 month follow-up visit.","Change in Exhaustion as Measured by the MFI Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire — At baseline and 6 month follow-up visit.","Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale. — At baseline and 6 month foll…","Change in Sense of Smell as Measured by UPSIT — At baseline and 6 month follow-up visit.","Death — Up to 12 months.","Change in Ejection Fraction (EF) — At baseline and 6 month follow-up visit.","Change in Inflammatory Markers Levels — At baseline and 6 month follow-up visit.","Change in Inflammatory Markers — At baseline and 6 month follow-up visit.","Change in Inflammatory Marker D-dimer Levels — At baseline and 6 month follow-up visit."],"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.","Abstract 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","abstract","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/50762","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}