Multiple SclerosisPhase 1/2UMSC01NCT05532943
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with Multiple Sclerosis, run by Ever Supreme Bio Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Allogeneic umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2023to 31 Oct 2028
- Phase
- Phase 1/2
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are willing to sign informed consent.
- Male or female are age between 20 to 65 years old on date of consent.
- 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)
- MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5 before enrollment
- Patient has appropriated blood clotting function as assessed by the following laboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
- 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
- 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
Who cannot join
- 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.
- Patients with uncontrolled diabetes (fasting blood glucose > 250 mg/dL)
- Patients with inadequate hepatic and renal function: AST and ALT > 5X ULN; eGFR < 30 mL/min.
- Patients who are unable to undergo Brain MRI examination for any reason.
- 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.
- 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.
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- With active infection that required systemic treatment
- Patients who are participating in other clinical trials with an investigational product within 1 month.
- Patients who were treated with cytotoxic medications during the last 1 month prior to the infusion.
- Relapse of MS within1 month before UMSC01 infusion.
- With anti-CD20 therapy, such as rituximab
- Patients not suitable to participate the trial as judged by the Investigator(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, Non-US, 404
Sammi Hsu, cthsu@ever-supreme.com.tw
Yuh C Guo, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Allogeneic umbilical cord mesenchymal stem cells, Control group
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic umbilical cord mesenchymal stem cellsBiological
UMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.
Control groupBiological
Normal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.
| Study group | Role | What they receive |
|---|---|---|
| UMSC01 | Experimental | UMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of multiple sclerosis. Receives: Biological: Allogeneic umbilical cord mesenchymal stem cells |
| Placebo | Sham comparator | 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. Receives: Biological: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint for Phase I portion
SAE, SUSAR, and AE incidences over the study period
Measured: from visit 2 to 12-month follow-up period
Primary Endpoint for Phase IIa portion
CFB of EDSS to Visit 10
Measured: from visit 2 to 12-month follow-up period
Secondary outcomes (25)
Efficacy endpoint for phase I portion
CFB for EDSS of follow up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB for brain MRI parameters of follow-up visits (Visit 6 -10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
Quality of life: CFB for MSQoL-54 questionnaire score of follow-up visits (Visit 6 -10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of T25FW scores of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of 9-HPT scores of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of PASAT scores of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of SDMT scores of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of RNFL thickness, measured by OCT of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoint for phase I portion
CFB of MSFC of follow-up visits (Visit 6-10)
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Time to onset of CDW confirmed by EDSS at least 6 months
Measured: from visit 2 to 6-month follow-up period
Efficacy endpoints for phase IIa portion
ARR (Annualized relapse rate), where relapse is defined as new or worsening neurological symptoms lasting for >24 hours
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow-up visits (Visit 6 -10) for EDSS
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for brain MRI parameters
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
Quality of life: CFB of follow up visits (Visit 6-10) for MSQoL-54 questionnaire score
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for T25FW scores
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for 9-HPT scores
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for PASAT scores
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for SDMT scores
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for RNFL thickness, measured by OCT
Measured: from visit 2 to 12-month follow-up period
Efficacy endpoints for phase IIa portion
CFB of follow up visits (Visit 6-10) for MSFC
Measured: from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
SAE, SUSAR, and AE incidences over the study period
Measured: from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
CFB of laboratory data to subsequent visits
Measured: from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
CFB of physical examination to subsequent visits
Measured: from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
CFB of vital signs to subsequent visits
Measured: from visit 2 to 12-month follow-up period
The safety endpoints are listed below for both phase I and IIa portions
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)
Measured: from visit 2 to 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start8 Sep 2023
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woei C Shyu, Study chair, Ever Supreme Bio Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532943
- Sponsor's protocol ID
- ES-CMSC01-D1101
- Acronym
- UMSC01
- Status last verified
- Aug 2025
- First submitted
- 5 Sep 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05532943
- Acronym / sponsor ID
- UMSC01 / ES-CMSC01-D1101
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Ever Supreme Bio Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 8 Sep 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UMSC01 | Experimental | Biological: Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells mixed with normal saline will be administered to patients after the onset of diagnosis of multiple sclerosis. |
| Placebo | Sham comparator | Biological: Control groupFor 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients are willing to sign informed consent.
- Male or female are age between 20 to 65 years old on date of consent.
- 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)
- MS diagnosis established between 2 to 15 years and EDSS score between 2.0 to 6.5 before enrollment
- Patient has appropriated blood clotting function as assessed by the following laboratory requirements: PT, APTT ≤ 1.5X upper limit of normal (ULN).
Key exclusion criteria (12 listed)
- 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.
- Patients with uncontrolled diabetes (fasting blood glucose > 250 mg/dL)
- Patients with inadequate hepatic and renal function: AST and ALT > 5X ULN; eGFR < 30 mL/min.
- Patients who are unable to undergo Brain MRI examination for any reason.
- 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.
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 |
|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cellsUMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment. | Biological | UMSC01 |
| Control groupNormal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment. | Biological | Placebo |
Primary outcome
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
Primary Endpoint for Phase IIa portion
Time frame: from visit 2 to 12-month follow-up period
CFB of EDSS to Visit 10
25 secondary outcomes
Efficacy endpoint for phase I portion
Time frame: 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
Efficacy endpoint for phase I portion
Time frame: 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
Efficacy endpoint for phase I portion
Time frame: 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
Efficacy endpoint for phase I portion
Time frame: 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
Efficacy endpoint for phase I portion
Time frame: 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
Efficacy endpoints for phase IIa portion
Time frame: 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
Efficacy endpoints for phase IIa portion
Time frame: 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
Efficacy endpoints for phase IIa portion
Time frame: 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
Efficacy endpoints for phase IIa portion
Time frame: 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
Efficacy endpoints for phase IIa portion
Time frame: 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
The safety endpoints are listed below for both phase I and IIa portions
Time frame: 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
The safety endpoints are listed below for both phase I and IIa portions
Time frame: 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
The safety endpoints are listed below for both phase I and IIa portions
Time frame: from visit 2 to 12-month follow-up period
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 7 Aug 2025.
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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.
Woei C Shyu study chair
Ever Supreme Bio Technology Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic umbilical cord mesenchymal stem cells in people with Multiple Sclerosis, run by Ever Supreme Bio Technology Co., Ltd. at 1 site in Taiwan.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sammi Hsu (886-4-2325-288, cthsu@ever-supreme.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint for Phase I portion (time frame: from visit 2 to 12-month follow-up period). 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 7 Aug 2025.