{"type":"trials","record":{"id":30232,"source_id":"clinicaltrials-gov","external_id":"NCT07705464","title":"Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome","brief_summary":"The purpose of this Phase I, open-label study is to evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Eligible participants will receive intravenous administration of MiraMSC-FS-001.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Miracle Biomedical Co., Ltd.","enrollment":12,"countries":[],"start_date":"2026-12-01","completion_date":"2028-06-30","last_update_date":"2026-07-15","source_url":"https://clinicaltrials.gov/study/NCT07705464","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":null,"organization":"Miracle Biomedical Co., Ltd.","interventions":["MiraMSC-FS-001"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Maximum Feasible Dose (MFD) of MiraMSC-FS-001 — Within 14 days after the last study treatment administration (3-dose co…","Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) — Baseline through Week 52","Exercise performance measured by 6-minute walk test (6MWT) total distance — Baseline, End of Treatment, Follow-up 1 (We…","Hand grip strength measured by maximum force using a hand dynamometer — Baseline, End of Treatment, Follow-up 1 (Week 2…","Physical performance measured by Short Physical Performance Battery (SPPB) total score — Baseline, End of Treatment, Fo…","Clinical Frailty Scale (CFS) score — Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Foll…","Quality of life measured by Falls Efficacy Scale-International (FES-I) questionnaire score — Baseline, End of Treatment…","Physical function measured by PROMIS Physical Function Short Form 20a score — Baseline, End of Treatment, Follow-up 1 (…","Quality of life measured by 36-Item Short Form (SF-36) survey score — Baseline, End of Treatment, Follow-up 1 (Week 24)…"],"design_description":"NA · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Frailty","MiraMSC-FS-001"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07705464","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-12-01 to 2028-06-30","comparator":null,"confidence":"structured-source","population":"ALL · 60 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":"2026-09-25T06:10:07.409Z","intervention":["MiraMSC-FS-001"],"participants":12,"study_design":"NA · SEQUENTIAL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["Maximum Feasible Dose (MFD) of MiraMSC-FS-001 — Within 14 days after the last study treatment administration (3-dose co…","Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) — Baseline through Week 52","Exercise performance measured by 6-minute walk test (6MWT) total distance — Baseline, End of Treatment, Follow-up 1 (We…","Hand grip strength measured by maximum force using a hand dynamometer — Baseline, End of Treatment, Follow-up 1 (Week 2…","Physical performance measured by Short Physical Performance Battery (SPPB) total score — Baseline, End of Treatment, Fo…","Clinical Frailty Scale (CFS) score — Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Foll…","Quality of life measured by Falls Efficacy Scale-International (FES-I) questionnaire score — Baseline, End of Treatment…","Physical function measured by PROMIS Physical Function Short Form 20a score — Baseline, End of Treatment, Follow-up 1 (…","Quality of life measured by 36-Item Short Form (SF-36) survey score — Baseline, End of Treatment, Follow-up 1 (Week 24)…"],"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.","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/30232","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}