{"type":"trials","record":{"id":35194,"source_id":"clinicaltrials-gov","external_id":"NCT07144072","title":"Safety and Tolerability Study of Mesenchymal Stem Cells, HeXell-2020, in Elderly Subjects With Mild to Moderate Frailty Syndrome","brief_summary":"This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome. HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Hexun Biosciences Co., LTD.","enrollment":12,"countries":[],"start_date":"2026-01-31","completion_date":"2028-07-31","last_update_date":"2025-09-04","source_url":"https://clinicaltrials.gov/study/NCT07144072","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":"2026-09-25T01:20:20.087268+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":"Hexun Biosciences Co., LTD.","interventions":["HeXell-2020"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Maximum Feasible Dose (MFD) determination — Within 14 days after completion of the last study treatment (day 28 for 3 d…","Incidence of Treatment-Emergent Adverse Events (TEAEs). — Within the first year after cell transplantation.","Incidence of withdrawals due to AEs — Within the first year after cell transplantation.","Mean change from baseline in exercise performance as measured by change in the six-minute walk test (6MWT) total distan…","Mean change from baseline in hand grip strength as measured by change in maximum force using hand dynamometer. — Day 0…","Mean change from baseline in physical activity as measured by change in the Short Physical Performance Battery (SPPB) a…","Mean change from baseline in Clinical Frailty Scale (CFS) score. — Day 0 (baseline), Week 6, 12, 24, 36, 52","Mean change from baseline in quality of life as measured by change in the Falls Efficacy Scale- International (FES-I) q…","Mean change from baseline in quality of life as measured by change in the Patient-Reported Outcomes Measurement Informa…","Mean change from baseline in quality of life as measured by change in the 36-Item Short Form survey (SF-36) score. — Da…"],"design_description":"NA · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Frailty in Older Adults","HeXell-2020"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct07144072","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-01-31 to 2028-07-31","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":"2026-09-25T06:10:07.488Z","intervention":["HeXell-2020"],"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) determination — Within 14 days after completion of the last study treatment (day 28 for 3 d…","Incidence of Treatment-Emergent Adverse Events (TEAEs). — Within the first year after cell transplantation.","Incidence of withdrawals due to AEs — Within the first year after cell transplantation.","Mean change from baseline in exercise performance as measured by change in the six-minute walk test (6MWT) total distan…","Mean change from baseline in hand grip strength as measured by change in maximum force using hand dynamometer. — Day 0…","Mean change from baseline in physical activity as measured by change in the Short Physical Performance Battery (SPPB) a…","Mean change from baseline in Clinical Frailty Scale (CFS) score. — Day 0 (baseline), Week 6, 12, 24, 36, 52","Mean change from baseline in quality of life as measured by change in the Falls Efficacy Scale- International (FES-I) q…","Mean change from baseline in quality of life as measured by change in the Patient-Reported Outcomes Measurement Informa…","Mean change from baseline in quality of life as measured by change in the 36-Item Short Form survey (SF-36) score. — Da…"],"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/35194","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}