FrailtyPhase 1NCT07705464
Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome
A Phase 1 study testing MiraMSC-FS-001 in people with Frailty, run by Miracle Biomedical Co., Ltd..
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Frailty
- What is being tested?
- MiraMSC-FS-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 6. 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.
Who cannot join
- 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;
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- 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.
- Subjects with known or suspected bleeding disorders (including but not limited to hemophilia, von Willebrand disease, or platelet function disorders), or clinically significant coagulopathy (including abnormal PT, PTT, or INR) at screening.
- Subjects receiving medications that may increase the risk of bleeding or coagulopathy (such as anticoagulants, antiplatelet agents, or thrombolytics), unless medically necessary and approved by the Medical Monitor on a case- by-case basis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of MiraMSC Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome
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.
Read the detailed description
Frailty syndrome (FS) is an age-related clinical condition characterized by reduced physiological reserve and increased vulnerability to adverse health outcomes, including falls, hospitalization, disability, and mortality. Despite its growing prevalence in the aging population, effective treatment options for frailty syndrome remain limited.
MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Preclinical studies have demonstrated the immunomodulatory, anti-inflammatory, and regenerative properties of UCMSCs, supporting their clinical evaluation as a potential treatment for frailty syndrome. In addition, GLP toxicology studies demonstrated a favorable nonclinical safety profile for MiraMSC-FS-001, supporting its further clinical evaluation in humans.
This Phase I, open-label, dose-escalation study will evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. Eligible participants will receive intravenous MiraMSC-FS-001 according to the study protocol and will undergo scheduled safety evaluations throughout the study. The results of this study are expected to provide clinical safety information to support the further development of MiraMSC-FS-001.
- Conditions
- Frailty
- Being tested
- MiraMSC-FS-001
- Keywords
- MiraMSC-FS-001, Mesenchymal Stem Cells (MSC), Frailty Syndrome (FS)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraMSC-FS-001Drug
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 group | Role | What they receive |
|---|---|---|
| MiraMSC-FS-001 | Experimental | Participants will receive intravenous MiraMSC-FS-001 Receives: Drug: MiraMSC-FS-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline through Week 52
Secondary outcomes (7)
Exercise performance measured by 6-minute walk test (6MWT) total distance
The Six-Minute Walk Test (6MWT) measures the total distance walked in six minutes on a hard, flat surface. Greater walking distance indicates better exercise performance.
Measured: 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
Hand grip strength is measured as the maximum force using a hand dynamometer. Higher values indicate greater muscle strength.
Measured: 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
The Short Physical Performance Battery (SPPB) assesses lower extremity physical function. Total scores range from 0 to 12, with higher scores indicating better physical performance.
Measured: 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
The Clinical Frailty Scale (CFS) assesses the overall level of frailty. Scores range from 1 to 9, with higher scores indicating greater frailty.
Measured: 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
The Falls Efficacy Scale-International (FES-I) assesses concern about falling during daily activities. Scores range from 16 to 64, with higher scores indicating greater concern about falling.
Measured: Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)
Physical function measured by PROMIS Physical Function Short Form 20a score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a assesses self-reported physical function. Total raw scores are converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating better physical function.
Measured: 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 36-Item Short Form (SF-36) survey score
The 36-Item Short Form Survey (SF-36) assesses health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single-arm, open-label study with two sequential dose-escalation cohorts
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miracle Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705464
- Sponsor's protocol ID
- MiraMSC-FS-001
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of MiraMSC Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome
- ClinicalTrials.gov ID
- NCT07705464
- Acronym / sponsor ID
- MiraMSC-FS-001
- Conditions
- Frailty
- Keywords
- MiraMSC-FS-001, Mesenchymal Stem Cells (MSC), Frailty Syndrome (FS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Miracle Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frailty syndrome (FS) is an age-related clinical condition characterized by reduced physiological reserve and increased vulnerability to adverse health outcomes, including falls, hospitalization, disability, and mortality. Despite its growing prevalence in the aging population, effective treatment options for frailty syndrome remain limited.
MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Preclinical studies have demonstrated the immunomodulatory, anti-inflammatory, and regenerative properties of UCMSCs, supporting their clinical evaluation as a potential treatment for frailty syndrome. In addition, GLP toxicology studies demonstrated a favorable nonclinical safety profile for MiraMSC-FS-001, supporting its further clinical evaluation in humans.
This Phase I, open-label, dose-escalation study will evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. Eligible participants will receive intravenous MiraMSC-FS-001 according to the study protocol and will undergo scheduled safety evaluations throughout the study. The results of this study are expected to provide clinical safety information to support the further development of MiraMSC-FS-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label study with two sequential dose-escalation cohorts
| Arm | Type | Receives |
|---|---|---|
| MiraMSC-FS-001 | Experimental | Drug: MiraMSC-FS-001Participants will receive intravenous MiraMSC-FS-001 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 6. 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.
Key exclusion criteria (27 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraMSC-FS-001MiraMSC-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). | Drug | MiraMSC-FS-001 |
Primary outcome
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).
Maximum Feasible Dose (MFD) determined based on the occurrence of dose-limiting toxicities (DLTs) after intravenous administration of MiraMSC-FS-001.
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Time frame: Baseline through Week 52
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.
7 secondary outcomes
Exercise performance measured by 6-minute walk test (6MWT) total distance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)
Physical function measured by PROMIS Physical Function Short Form 20a score
Time frame: 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 36-Item Short Form (SF-36) survey score
Time frame: Baseline, End of Treatment, Follow-up 1 (Week 24), Follow-up 2 (Week 36), and Follow-up 3 (Week 52)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MiraMSC-FS-001 in people with Frailty, run by Miracle Biomedical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin-Chung Lin (+886-3-358999, oscar.lin@miracle-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.