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Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Sponsor: Ever Supreme Bio Technology Co., Ltd.
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. 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.
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
Key Details
Gender
All
Age Range
20 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2023-09-08
Completion Date
2028-10-31
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
Allogeneic umbilical cord mesenchymal stem cells
UMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.
Control group
Normal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.
Locations (1)
China Medical University Hospital
Taichung, Non-US, Taiwan