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

NCT05532943 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells

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

BIOLOGICAL

Control group

Normal saline will be IV infusion followed by sham-IT infusion with 12 months of follow up after treatment.

Sponsors & Collaborators

  • Ever Supreme Bio Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Woei C Shyu · Ever Supreme Bio Technology Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532943 on ClinicalTrials.gov