{"type":"trials","record":{"id":34966,"source_id":"clinicaltrials-gov","external_id":"NCT07462819","title":"A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty Syndrome","brief_summary":"This is a Phase 1 clinical study designed to evaluate the safety and tolerability of an investigational cell therapy product, Stemis™, in older adults with mild to moderate frailty. Frailty is a condition commonly seen in older adults and may include decreased strength, slower walking speed, and reduced ability to perform daily activities. Currently, there is no specific drug treatment approved for frailty. Stemis™ is an investigational product made from human umbilical cord-derived mesenchymal stem cells. This product has been evaluated for safety in nonclinical studies and in clinical studies for other conditions. Approximately 12 participants between 60 and 85 years of age who have been assessed as having mild to moderate frailty will take part in this study. Participants will be randomly assigned to receive either Stemis™ or a placebo (saltwater solution). The study is double-blind, meaning that neither the participants nor the study staff will know which treatment is given. The study treatment will be administered by intravenous infusion. During the study, participants will be closely monitored for safety, including the occurrence of adverse events, vital signs, laboratory tests, and physical examinations. In addition, assessments such as walking ability, hand grip strength, and quality-of-life questionnaires will be performed as exploratory measures. This study is not intended to provide direct medical benefit to participants. The primary purpose of the study is to collect safety information to support future clinical research.","overall_status":"Not Yet Recruiting","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Ji Yan Biomedical Co., Ltd.","enrollment":12,"countries":["Taiwan"],"start_date":"2026-04-01","completion_date":"2028-12-01","last_update_date":"2026-03-19","source_url":"https://clinicaltrials.gov/study/NCT07462819","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":"Saline Placebo","organization":"Ji Yan Biomedical Co., Ltd.","interventions":["Stemis™","Normal Saline"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs)…","Incidence of Treatment-Emergent Adverse Events (TEAEs) — From first administration of study intervention through 26 wee…","Incidence of withdrawals due to adverse events (AEs) — From first administration of study intervention through 26 weeks…","Number of Participants with Clinically Significant Changes in Physical Examination Findings — From first administration…","Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results — From first administrat…","Number of Participants with Clinically Significant Changes in Vital Signs — From first administration of study interven…","Six-Minute Walk Test (6MWT) — From baseline through 26 weeks after the last dose","Hand Grip Strength - maximum force — From baseline through 26 weeks after the last dose","Short Physical Performance Battery (SPPB) - total score — From baseline through 26 weeks after the last dose","Clinical Frailty Scale (CFS) - score — From baseline through 26 weeks after the last dose","Falls Efficacy Scale-International (FES-I) - total score — From baseline through 26 weeks after the last dose","PROMIS Physical Function Short Form 20a - T-score — From baseline through 26 weeks after the last dose","World Health Organization Quality of Life-BREF (WHOQOL-BREF) - domain scores — From baseline through 26 weeks after the…","12-Item Short Form Health Survey (SF-12) - Physical and Mental Component Summary scores — From baseline through 26 week…","Creatine Phosphokinase (CPK) — From baseline through 26 weeks after the last dose","N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) — From baseline through 26 weeks after the last dose"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Frailty Syndrome","Stemis™","Normal Saline"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct07462819","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-04-01 to 2028-12-01","comparator":"Saline Placebo","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":"2026-09-25T06:10:07.454Z","intervention":["Stemis™","Normal Saline"],"participants":12,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs)…","Incidence of Treatment-Emergent Adverse Events (TEAEs) — From first administration of study intervention through 26 wee…","Incidence of withdrawals due to adverse events (AEs) — From first administration of study intervention through 26 weeks…","Number of Participants with Clinically Significant Changes in Physical Examination Findings — From first administration…","Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results — From first administrat…","Number of Participants with Clinically Significant Changes in Vital Signs — From first administration of study interven…","Six-Minute Walk Test (6MWT) — From baseline through 26 weeks after the last dose","Hand Grip Strength - maximum force — From baseline through 26 weeks after the last dose","Short Physical Performance Battery (SPPB) - total score — From baseline through 26 weeks after the last dose","Clinical Frailty Scale (CFS) - score — From baseline through 26 weeks after the last dose","Falls Efficacy Scale-International (FES-I) - total score — From baseline through 26 weeks after the last dose","PROMIS Physical Function Short Form 20a - T-score — From baseline through 26 weeks after the last dose","World Health Organization Quality of Life-BREF (WHOQOL-BREF) - domain scores — From baseline through 26 weeks after the…","12-Item Short Form Health Survey (SF-12) - Physical and Mental Component Summary scores — From baseline through 26 week…","Creatine Phosphokinase (CPK) — From baseline through 26 weeks after the last dose","N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) — From baseline through 26 weeks after the last dose"],"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/34966","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}