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.
Subjects aged ≥ 60 through ≤ 85 years old.
Subjects with clinical diagnosis of mild to moderate FS as assessed by the Investigator with a CFS score between 4 to 6.
Subjects will not start any new treatment for this condition during the study.
Subjects with body weight between 40 to 90 kg.
Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.
Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.
Severe kidney disease requiring hemodialysis or peritoneal dialysis.
Parallel
Stemis™
Biological/VaccineStemis™ is an investigational cell therapy product administered by intravenous infusion. Participants assigned to this intervention will receive multiple administrations of Stemis™. The dosing frequency and administration schedule differ by cohort, and safety monitoring is conducted throughout the study.
Normal Saline
DrugNormal Saline
Determination of the Maximum Feasible Dose (MFD) of Stemis™ based on the occurrence of Dose-Limiting Toxicities (DLTs)
Determination of the maximum feasible dose (MFD) of Stemis™ based on the occurrence of dose-limiting toxicities (DLTs). A DLT is defined as any treatment-related adverse event or clinically significant laboratory abnormality meeting the protocol-specified DLT criteria and occurring within 14 days after completion of the last study intervention dose.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing one or more treatment-emergent adverse events (TEAEs) following administration of study intervention.
Incidence of withdrawals due to adverse events (AEs)
Number of participants who permanently discontinue study intervention or withdraw from the study due to an adverse event.
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Number of participants with clinically significant abnormal findings on physical examination, as assessed by the investigator
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures the total distance an individual is able to walk over a period of six minutes on a hard, flat surface. Participants are instructed to walk as far as possible during the six-minute period and are allowed to self-pace and rest as needed while traversing a marked walkway. The outcome measure is the total distance walked, expressed in meters.
Hand Grip Strength - maximum force
Hand grip strength is a measure of the maximum static force generated by the hand using a hydraulic hand dynamometer. The outcome measure is the maximum grip strength recorded, expressed in kilograms.
Short Physical Performance Battery (SPPB) - total score
The Short Physical Performance Battery (SPPB) total score is a composite measure of physical function derived from three lower-extremity performance tests: standing balance, 4-meter walking speed, and repeated chair stands. Each component is scored on a 0-4 scale, with higher scores indicating better physical performance. The total SPPB score ranges from 0 to 12.
Clinical Frailty Scale (CFS) - score
The Clinical Frailty Scale (CFS) is a clinician-rated measure of overall fitness or frailty based on evaluation of comorbidity, functional status, and cognition. The CFS score ranges from 1 to 9, where lower scores indicate better fitness and higher scores indicate greater frailty, with 9 representing terminal illness.
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Ji Yan Biomedical Co., Ltd.
Lead sponsor
YC Biotech Co., Ltd.
Collaborator
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