NCT07462819

A Study to Evaluate the Safety and Tolerability of Intravenous Stemis™ in Elderly Subjects With Mild to Moderate Frailty Syndrome

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Stemis™ Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Ji Yan Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frailty Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Stemis™	Stemis™ 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.
DRUG	Normal Saline	Normal Saline

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2026-03-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study