Actively Recruiting
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Led by Ever Supreme Bio Technology Co., Ltd. · Updated on 2025-08-07
41
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign informed consent
- Male or female aged between 20 to 65 years at consent
- Diagnosis of Relapsing-Remitting MS or Secondary Progressive MS with specific documented relapses or lesions
- MS diagnosis established between 2 to 15 years with EDSS score between 2.0 to 6.5 before enrollment
- Appropriate blood clotting function with PT and APTT less than or equal to 1.5 times the upper limit of normal
- Treatment failure with at least one MS disease-modifying therapy for more than 6 months
- Use of appropriate contraception for males and females with child-bearing potential during and for 4 weeks after treatment
You will not qualify if you...
- Pregnancy, lactation, or unwillingness to use effective contraception 4 weeks before and after treatment
- Uncontrolled diabetes with fasting blood glucose over 250 mg/dL
- Inadequate liver or kidney function (AST and ALT over 5 times upper limit, or eGFR below 30 mL/min)
- Inability to undergo brain MRI examination
- History or current active malignant tumor, peripheral neuropathy, myopathy, or significant neurological diseases affecting evaluation
- Immunocompromised status, autoimmune conditions other than MS, or recent immunosuppressive treatments other than MS therapy
- Active infection requiring systemic treatment
- Participation in other clinical trials with investigational products within 1 month
- Treatment with cytotoxic medications in the last month prior to infusion
- MS relapse within 1 month before UMSC01 infusion
- Previous anti-CD20 therapy such as rituximab
- Investigator judgment deeming patient unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, Non-US, Taiwan, 404
Actively Recruiting
Research Team
S
Sammi Hsu
CONTACT
J
Jack Tsai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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