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

Multiple Sclerosis Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05532943
Study type Interventional
Source Ever Supreme Bio Technology Co., Ltd.
Contact Sammi Hsu
Phone 886-4-2325-288
Email cthsu@ever-supreme.com.tw
Status Recruiting
Phase Phase 1/Phase 2
Start date September 8, 2023
Completion date December 31, 2026
View Details
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