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

NCT07705464 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: MiraMSC-FS-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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

Frailty

Keywords

MiraMSC-FS-001; Mesenchymal Stem Cells (MSC); Frailty Syndrome (FS)

Outcome Measures

Primary Outcomes (2)

• Maximum Feasible Dose (MFD) of MiraMSC-FS-001

  Maximum Feasible Dose (MFD) determined based on the occurrence of dose-limiting toxicities (DLTs) after intravenous administration of MiraMSC-FS-001.

  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).

• Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

  Safety and overall tolerability of MiraMSC-FS-001 will be evaluated based on the incidence and nature of dose-limiting toxicities (DLTs), the incidence of treatment-emergent adverse events (TEAEs), the incidence of withdrawals due to adverse events (AEs), changes/shifts in laboratory values, changes in vital signs, and changes in physical examination findings.

  Baseline through Week 52

Secondary Outcomes (7)

• Exercise performance measured by 6-minute walk test (6MWT) total distance

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Hand grip strength measured by maximum force using a hand dynamometer

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Physical performance measured by Short Physical Performance Battery (SPPB) total score

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Clinical Frailty Scale (CFS) score

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Quality of life measured by Falls Efficacy Scale-International (FES-I) questionnaire score

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

Other Outcomes (4)

• Mean change from baseline in superoxide dismutase (SOD) level

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Mean change from baseline in tumor necrosis factor-alpha (TNF-α) level

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

• Mean change from baseline in creatine phosphokinase (CPK) level

  Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)

Study Arms (1)

MiraMSC-FS-001

EXPERIMENTAL

Participants will receive intravenous MiraMSC-FS-001

Drug: MiraMSC-FS-001

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).

MiraMSC-FS-001

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Miracle Biomedical Co., Ltd.: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chin-Chung Lin

CONTACT

+886-3-358999; oscar.lin@miracle-bio.com

Che-Chia Liu

CONTACT

+886-3-358999; aaron.liu@miracle-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study with no masking of participants, investigators, or study personnel.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label study with two sequential dose-escalation cohorts

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share