Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Study Overview
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Brief Summary
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Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis. Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.

Official Title
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Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Conditions
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Progressive Multiple Sclerosis, Neuromyelitis Optica.

Intervention / Treatment
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* Biological: human umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica. Aged 16-65 years. Disease duration≥2years Poor response to steroid therapy. Written informed consent and follow the clinic trail procedure Exclusion Criteria: Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value. Combined Pneumonia or other Severe systemic bacteria infection. Severe drug allergic history or anaphylaxis to 2 or more food or medicine. Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/ HIV+, TPPA +， patients diagnosed as HBV or HCV. Tumor Markers + Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form. Coagulation disorders. Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg. Pregnancy. Enrollment in other trials in the last 3 months. Other criteria the investigator consider improper for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human umbilical cord mesenchymal stem cells transplantation<br>Intervention group | Biological: human umbilical cord mesenchymal stem cells<br>* Participants will be given hUC-MSCs transplantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of Expanded Disability Status Scale (EDSS) |  | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Evoked Potential (VEP) |  | 1 year after treatment | 
| Brainstem Auditory Evoked Potential (BAEP) |  | 1 year after treatment | 
| Somatosensory Evoked Potential(SEP) |  | 1 year after treatment | 
| Brain Magnetic Resonance Imaging （MRI） Scan |  | 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive Multiple Sclerosis, neuromyelitis optica, Umbilical Cord Mesenchymal Stem Cell