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

Phase 1

• Conditions: Progressive Multiple Sclerosis; Neuromyelitis Optica.
• Interventions: Biological: human umbilical cord mesenchymal stem cells

• Registration Number: NCT01364246
• Lead Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-26
• Last Update Posted: 2012-11-28
• Primary Completion: 2013-03
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human umbilical cord mesenchymal stem cells transplantation	human umbilical cord mesenchymal stem cells	Intervention group

Primary Outcome Measures

Name	Time	Method
Score of Expanded Disability Status Scale (EDSS)	1 year after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nanjing University Medical College Affiliated Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China