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

NCT07705464 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

MiraMSC-FS-001

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).

Sponsors & Collaborators

  • Miracle Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705464 on ClinicalTrials.gov