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

NCT07462819 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • YC Biotech Co., Ltd.

    collaborator UNKNOWN

  • Ji Yan Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-09-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462819 on ClinicalTrials.gov