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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty Syndrome
• Intervention / Treatment: Drug: Normal Saline; Biological: Stemis™

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects will be eligible for enrollment in the study only if they meet all the following criteria at time of Screening:

1. Subjects aged ≥ 60 through ≤ 85 years old.
2. Subjects with clinical diagnosis of mild to moderate FS as assessed by the Investigator with a CFS score between 4 to 6.
3. Subjects will not start any new treatment for this condition during the study.
4. Subjects with body weight between 40 to 90 kg.
5. Subjects are willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

Exclusion Criteria:

Subjects meeting any of the following criteria at time of Screening will be excluded from enrollment:

1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
2. 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.
3. Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.

4. 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)
5. Subjects who have a history of deep venous thrombosis or pulmonary embolism, known hypercoagulability, or known family history of thromboembolic disease.
6. 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.
7. Subjects using chronic immunosuppressant therapy, including corticosteroids (> 5 mg/day of prednisone, or equivalent), or TNF-alpha antagonists.
8. Subjects on chronic immunosuppressive transplant therapy.
9. Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.
10. Subjects who have received any other stem cell therapy within 12 months prior to screening.
11. Subjects with known allergies or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).
12. Subjects who have a history of drug or alcohol abuse within the past 3 years.
13. Subjects who are known to be infected with Human Immunodeficiency Virus (HIV).
14. Subjects are currently hospitalized.

15. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to:

    • Psychiatric illness
    • Uncontrolled hypertension or hypotension
    • Unstable cardiac arrhythmia
    • Active Hepatitis B, Hepatitis C infections
16. Subjects who have any condition that in the opinion of the PI limits lifespan to < 1 year.

17. Subjects who have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEMIS-1; Participants receive Stemis™ administered by intravenous infusion.	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.
Placebo Comparator: Saline Placebo; Participants receive placebo (normal saline) administered by intravenous infusion.	Drug: Normal Saline; Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline through 26 weeks after the last dose
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.	From baseline through 26 weeks after the last dose
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.	From baseline through 26 weeks after the last dose
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.	From baseline through 26 weeks after the last dose
Falls Efficacy Scale-International (FES-I) - total score	The Falls Efficacy Scale-International (FES-I) is a 16-item self-reported questionnaire that assesses concern about falling during daily activities. Each item is scored on a 4-point scale, and the total score ranges from 16 to 64, with higher scores indicating greater concern about falling.	From baseline through 26 weeks after the last dose
PROMIS Physical Function Short Form 20a - T-score	The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a is a 20-item self-reported questionnaire that assesses an individual's ability to perform physical activities, ranging from activities of daily living to more demanding physical tasks. Responses are scored and converted to standardized T-scores (mean 50, standard deviation 10), with higher scores indicating better physical function.	From baseline through 26 weeks after the last dose
World Health Organization Quality of Life-BREF (WHOQOL-BREF) - domain scores	The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item questionnaire that assesses quality of life across four domains: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale. Domain scores are calculated according to WHOQOL-BREF scoring guidelines, with higher scores indicating better quality of life.	From baseline through 26 weeks after the last dose
12-Item Short Form Health Survey (SF-12) - Physical and Mental Component Summary scores	The 12-Item Short Form Health Survey (SF-12) is a self-reported questionnaire that assesses health-related quality of life across physical and mental health domains. Results are summarized into two standardized scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health status.	From baseline through 26 weeks after the last dose
Creatine Phosphokinase (CPK)	Change from baseline in serum creatine phosphokinase (CPK) levels as a biomarker of muscle and inflammatory status.	From baseline through 26 weeks after the last dose
N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)	Change from baseline in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a biomarker of cardiac stress.	From baseline through 26 weeks after the last dose

Collaborators and Investigators

• Sponsor: Ji Yan Biomedical Co., Ltd.
• Collaborators: YC Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Frailty; MSC; Frailty Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: JY-STEMIS-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No