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.
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
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.
Parallel
Allogeneic umbilical cord mesenchymal stem cells
Biological/VaccineUMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.
Control group
Biological/VaccineNormal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.
Primary Endpoint for Phase I portion
SAE, SUSAR, and AE incidences over the study period
Primary Endpoint for Phase IIa portion
CFB of EDSS to Visit 10
Efficacy endpoint for phase I portion
CFB for EDSS of follow up visits (Visit 6-10)
Efficacy endpoint for phase I portion
CFB for brain MRI parameters of follow-up visits (Visit 6 -10)
Efficacy endpoint for phase I portion
Quality of life: CFB for MSQoL-54 questionnaire score of follow-up visits (Visit 6 -10)
Efficacy endpoint for phase I portion
CFB of T25FW scores of follow-up visits (Visit 6-10)
The exploratory endpoints are listed below for both phase I and IIa portions
Immunological markers, including CD3, CD4, CD8 surface markers, IgG, IgM, anti-HLA antibodies and Panel Reactive Antibody Assay in whole blood
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