RecruitingPhase 1Phase 2NCT05532943

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

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


Sponsor

Ever Supreme Bio Technology Co., Ltd.

Enrollment

41 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether infusions of umbilical cord-derived mesenchymal stem cells can safely reduce relapses and slow disability progression in people with relapsing-remitting or secondary progressive multiple sclerosis (MS) who have not responded well to standard MS medications. **You may be eligible if...** - You are 20–65 years old with a confirmed diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) - Your MS was diagnosed 2–15 years ago, and your disability score (EDSS) is between 2.0 and 6.5 - You have had at least one relapse, new brain lesion, or worsening disability despite being on an approved MS disease-modifying therapy for more than 6 months - Your blood clotting function is normal **You may NOT be eligible if...** - You are pregnant - You are unwilling to use contraception after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic umbilical cord mesenchymal stem cells

UMSC01 cells will be IV infusion followed by IT infusion with 12 months of follow up after treatment.

BIOLOGICALControl 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

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NCT05532943


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