Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome (NCT07705464) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome
12 participantsStarted 2026-12-01
Plain-language summary
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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Feasible Dose (MFD) of MiraMSC-FS-001
Timeframe: Within 14 days after the last study treatment administration (3-dose cohort: last dose on Day 28; 6-dose cohort: last dose on Day 70).
2
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)