Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis (UMSC01)

August 4, 2025 updated by: Ever Supreme Bio Technology Co., Ltd.

A Seamless Phase I/IIa Clinical Study to Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis

This study is to identify the safety and efficacy of repeat IV(Intravenous) and IT(Intrathecal) administrations of UMSC01 in patients with MS. While anti-inflammatory drugs are routinely used for the treatment of MS by inhibiting immune responses, their effects on axon remyelination or neuroregeneration are limited. The combined systemic delivery of UCMSCs via intravenous injection and local administration of the cells by IT was to have safety and therapeutic efficacy for patients with MS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is single arm in Phase I part: 6 patients will be enrolled sequentially for safety considerations. The patient will receive UMSC01 via IV followed by IT at day 28 as described in above. After all patients in Phase I complete the safety assessment by SMC without any major safety issue 4 weeks after the last UMSC01 administration, the Phase IIa part will be initiated. There are 2 arms in Phase IIa part: Sham-controlled with conventional treatment control and administration of UMSC01 with conventional treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Non-US
      • Taichung, Non-US, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Yuh C Guo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients are willing to sign informed consent.
  2. Male or female are age between 20 to 65 years old on date of consent.
  3. Diagnosis of Relapsing-Remitting MS (RRMS) (≥1 clinically documented relapse in the past 12 months, ≥2 clinically documented relapses in the last 24 months or ≥ 1 gadolinium enhanced lesion or T2 new lesion in the last 12 months) or Secondary Progressive MS (SPMS) (EDSS increase ≥1.0 point (baseline EDSS ≤ 5.0) or ≥ 0.5 point (baseline EDSS ≥5.5), and ≥1 clinical relapse or ≥1 gadolinium enhanced lesion in the last 12 months)
  4. MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5 before enrollment
  5. Patient has appropriated blood clotting function as assessed by the following laboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
  6. Treatment failure (either ≥ 1 relapse, ≥ 1 new T2 lesion, ≥ one gadolinium enhanced lesion or EDSS deterioration) with at least one of MS disease modifying therapy as Interferon-β, Glatiramer acetate (Copaxone), Dimethyl fumarate (Tecfidera), Teriflunomide (Aubagio), Fingolimod (Gilenya), Ozanimod (Zeposia), Cladribine (Mavenclad), Siponimod (Mayzent), Ofatumumab (Kesimpta), or Natalizumab (Tysabri) for more than 6 months
  7. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after UMSC01 treatment

Exclusion Criteria:

  1. Pregnancy, lactation, and those who are not pregnant but did not, or unwilling to, take effective contraceptives measures 4 weeks before and after the treatment.
  2. Patients with uncontrolled diabetes (fasting blood glucose > 250 mg/dL)
  3. Patients with inadequate hepatic and renal function: AST and ALT > 5X ULN; eGFR < 30 mL/min.
  4. Patients who are unable to undergo Brain MRI examination for any reason.
  5. Patients who have medical history or current clinically active malignant tumor, peripheral neuropathy, myopathy or other clinically significant neurological diseases that will confound the evaluation of this study.
  6. Patients who have immuno-compromised condition or is with known clinically significantly autoimmune conditions other than MS or is receiving immunosuppressive treatments other than MS treatment within 6 months.
  7. With active infection that required systemic treatment
  8. Patients who are participating in other clinical trials with an investigational product within 1 month.
  9. Patients who were treated with cytotoxic medications during the last 1 month prior to the infusion.
  10. Relapse of MS within1 month before UMSC01 infusion.
  11. With anti-CD20 therapy, such as rituximab
  12. Patients not suitable to participate the trial as judged by the Investigator(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UMSC01
UMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of multiple sclerosis.
Biological: Allogeneic umbilical cord mesenchymal stem cells
UMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.
Sham Comparator: Placebo
For IV administration, normal saline will be administered to patients after the onset of diagnosis of multiple sclerosis. For IT administration, sham puncture procedure will partially penetrate without reaching subarachnoid space, and no spinal fluid will be drawn.
Biological: Control group
Normal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Endpoint for Phase I portion
Time Frame: from visit 2 to 12-month follow-up period
SAE, SUSAR, and AE incidences over the study period
from visit 2 to 12-month follow-up period
Primary Endpoint for Phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of EDSS to Visit 10
from visit 2 to 12-month follow-up period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB for EDSS of follow up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB for brain MRI parameters of follow-up visits (Visit 6 -10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
Quality of life: CFB for MSQoL-54 questionnaire score of follow-up visits (Visit 6 -10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of T25FW scores of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of 9-HPT scores of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of PASAT scores of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of SDMT scores of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of RNFL thickness, measured by OCT of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of MSFC of follow-up visits (Visit 6-10)
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 6-month follow-up period
Time to onset of CDW confirmed by EDSS at least 6 months
from visit 2 to 6-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
ARR (Annualized relapse rate), where relapse is defined as new or worsening neurological symptoms lasting for >24 hours
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow-up visits (Visit 6 -10) for EDSS
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for brain MRI parameters
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
Quality of life: CFB of follow up visits (Visit 6-10) for MSQoL-54 questionnaire score
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for T25FW scores
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for 9-HPT scores
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for PASAT scores
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for SDMT scores
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for RNFL thickness, measured by OCT
from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time Frame: from visit 2 to 12-month follow-up period
CFB of follow up visits (Visit 6-10) for MSFC
from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
SAE, SUSAR, and AE incidences over the study period
from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
CFB of laboratory data to subsequent visits
from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
CFB of physical examination to subsequent visits
from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
CFB of vital signs to subsequent visits
from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
CFB of AFP, CEA, CA199, SCC, IgA, anti-EBV, β-HCG, CA125, CA153, and PSA to Visit 6 (Phase I) or Visit 10 (Phase IIa)
from visit 2 to 12-month follow-up period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The exploratory endpoints are listed below for both phase I and IIa portions
Time Frame: from visit 2 to 12-month follow-up period
Immunological markers, including CD3, CD4, CD8 surface markers, IgG, IgM, anti-HLA antibodies and Panel Reactive Antibody Assay in whole blood
from visit 2 to 12-month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ever Supreme Bio Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Woei C Shyu, Ever Supreme Bio Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES-CMSC01-D1101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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