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

This study is currently recruiting participants.

Verified October 2011 by Shenzhen Beike Bio-Technology Co., Ltd.

First Received on May 31, 2011. Last Updated on October 13, 2011 History of Changes

Sponsor:	Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators:	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School The Affiliated Nanjing Brain Hospital of Nanjing University Medical School Nanjing University Medical College Affiliated Wuxi Second Hospital Affiliated Hospital of Xuzhou Medical College The Second Hospital of Nanjing Medical University
Information provided by (Responsible Party):	Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01364246

Purpose

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.

Condition	Intervention	Phase
Progressive Multiple Sclerosis Neuromyelitis Optica.	Biological: human umbilical cord mesenchymal stem cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Resource links provided by NLM:

Genetics Home Reference related topics: neuromyelitis optica

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Primary Outcome Measures:

Score of Expanded Disability Status Scale (EDSS) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Evoked Potential (VEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
Brainstem Auditory Evoked Potential (BAEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
Somatosensory Evoked Potential(SEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
Brain Magnetic Resonance Imaging （MRI） Scan [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Human umbilical cord mesenchymal stem cells transplantation Intervention group	Biological: human umbilical cord mesenchymal stem cells Participants will be given hUC-MSCs transplantation.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364246

Contacts

Contact: Yun Yun Xu

xuyun20042001@yahoo.com.cn

Locations

China, Jiangsu
Nanjing University Medical College Affiliated Drum Tower Hospital	Recruiting
Nanjing, Jiangsu, China
Contact: Yun Xu xuyun20042001@yahoo.com.cn

Sponsors and Collaborators

Shenzhen Beike Bio-Technology Co., Ltd.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The Affiliated Nanjing Brain Hospital of Nanjing University Medical School

Nanjing University Medical College Affiliated Wuxi Second Hospital

Affiliated Hospital of Xuzhou Medical College

The Second Hospital of Nanjing Medical University

More Information

No publications provided

Responsible Party:	Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01364246 History of Changes
Other Study ID Numbers:	BKCR-MS-1.0(2010)
Study First Received:	May 31, 2011
Last Updated:	October 13, 2011
Health Authority:	China: Ministry of Health

Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:

Progressive Multiple Sclerosis
neuromyelitis optica
Umbilical Cord Mesenchymal Stem Cell

Additional relevant MeSH terms:

Multiple Sclerosis
Neuromyelitis Optica
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012