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

NCT07462819 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: JY-STEMIS-007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Keywords

Frailty; Frailty Syndrome; MSC

Outcome Measures

Primary Outcomes (6)

• 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.

  From first dose (Day 1) through 26 weeks after the last 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.

  From first administration of study intervention through 26 weeks after the last dose

• 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.

  From first administration of study intervention through 26 weeks after the last dose

• 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

  From first administration of study intervention through 26 weeks after the last dose

• Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results

  Number of participants with clinically significant abnormal findings in clinical laboratory tests (including hematology, biochemistry, and urinalysis), as assessed by the investigator

  From first administration of study intervention through 26 weeks after the last dose

• Number of Participants with Clinically Significant Changes in Vital Signs

  Number of participants with clinically significant abnormal findings in vital signs assessments (including blood pressure, heart rate, respiratory rate, and body temperature), as assessed by the investigator

  From first administration of study intervention through 26 weeks after the last dose

Secondary Outcomes (10)

• 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

Study Arms (2)

STEMIS-1

EXPERIMENTAL

Participants receive Stemis™ administered by intravenous infusion.

Biological: Stemis™

Saline Placebo

PLACEBO COMPARATOR

Participants receive placebo (normal saline) administered by intravenous infusion.

Drug: Normal Saline

Interventions

Stemis™ BIOLOGICAL

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.

STEMIS-1

Normal Saline DRUG

Normal Saline

Saline Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet all the following criteria at time of Screening:
• 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 are willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

You may not qualify if:

• Subjects meeting any of the following criteria at time of Screening will be excluded from enrollment:
• 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.
• Subjects who have a significant comorbid medical condition(s) including, but not limited to:
• Severe kidney disease requiring hemodialysis or peritoneal dialysis.
• Advanced liver diseases such as severe liver cirrhosis.
• Severe congestive heart failure (NYHA class 3 and 4).
• Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)
• Subjects who have a history of deep venous thrombosis or pulmonary embolism, known hypercoagulability, or known family history of thromboembolic disease.
• Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma or in situ carcinomas.
• Subjects using chronic immunosuppressant therapy, including corticosteroids (\> 5 mg/day of prednisone, or equivalent), or TNF-alpha antagonists.
• Subjects on chronic immunosuppressive transplant therapy.
• Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.
• Subjects who have received any other stem cell therapy within 12 months prior to screening.

Sponsors & Collaborators

• Ji Yan Biomedical Co., Ltd.: lead
• YC Biotech Co., Ltd.: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)