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

Sponsor
Miracle Biomedical Co., Ltd.
Study ID
NCT07705464
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Frailty

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • MiraMSC-FS-001 — DRUG
    MiraMSC-FS-001 is an investigational biological product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Two treatment cohorts are included: Cohort 1: 9 × 10⁷ cells per dose, administered by intravenous infusion every 2 weeks for a total of 3 doses (total dose: 2.7 × 10⁸ cells). Cohort 2: 9 × 10⁷ cells per dose, administered by intravenous infusion every 2 weeks for a total of 6 doses (total dose: 5.4 × 10⁸ cells).

Study Details

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 Dates

First listed
Jul 15, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MiraMSC-FS-001
    Participants will receive intravenous MiraMSC-FS-001

Primary Outcome Measure

Maximum Feasible Dose (MFD) of MiraMSC-FS-001 [ Time Frame: 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). ]

Central Contacts

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