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.
Ji Yan Biomedical Co., Ltd.
Lead sponsor
YC Biotech Co., Ltd.
Collaborator