Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome

Starting soon · Phase 1

Conditions studied: Frailty

In brief

The purpose of this Phase I, open-label study is to evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Eligible participants will receive intravenous administration of MiraMSC-FS-001.

Key facts

Study ID

NCT07705464

Run by

Miracle Biomedical Co., Ltd.

People needed

12

Starts

2026-12-01

Expected to finish

2028-06-30

Last updated by the study team

2026-07-15

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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 Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to
• 3. Subject will not start any new treatment for this condition during the study.
• The new treatment refers to any clinical study of new investigational therapies or any other stem cell therapies. Subject will be allowed to continue ongoing medications and therapies that are not prohibited treatment as listed in Section 6.4.1 and are deemed necessary by the Investigator for appropriate medical care. Minor modifications or dose adjustments to ongoing frailty- related treatments that were initiated prior to study enrollment and are not prohibited by the protocol may be implemented if deemed necessary by the Investigator for appropriate care; such adjustments will not be considered the initiation of a new treatment. ** 4. Subjects with body weight between 40 to 90 kg. 5. Subject is 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 unwill ing 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 disease 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 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.
• Subjects with known allergy or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).
• Subjects who have a history of drug or alcohol abuse within the past 3 years.
• Subjects who are known to be infected with HIV.
• Subjects currently in hospital stay.
• 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
• Subjects who have any condition that in the opinion of the Principal investigator limits lifespan to < 1 year.
• 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.

Full record on ClinicalTrials.gov

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