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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01364246
Recruitment Status : Unknown
Verified November 2012 by Shenzhen Beike Bio-Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 2, 2011
Last Update Posted : November 28, 2012
Sponsor:
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
Xuzhou Medical University
The Second Hospital of Nanjing Medical University
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Score of Expanded Disability Status Scale (EDSS) [ Time Frame: 1 year after treatment ]

Secondary Outcome Measures :
  1. Visual Evoked Potential (VEP) [ Time Frame: 1 year after treatment ]
  2. Brainstem Auditory Evoked Potential (BAEP) [ Time Frame: 1 year after treatment ]
  3. Somatosensory Evoked Potential(SEP) [ Time Frame: 1 year after treatment ]
  4. Brain Magnetic Resonance Imaging （MRI） Scan [ Time Frame: 1 year after treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364246


Contacts
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Contact: Yun Yun Xu xuyun20042001@yahoo.com.cn

Locations
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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
Xuzhou Medical University
The Second Hospital of Nanjing Medical University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01364246    
Other Study ID Numbers: BKCR-MS-1.0(2010)
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012
Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Progressive Multiple Sclerosis
neuromyelitis optica
Umbilical Cord Mesenchymal Stem Cell
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Neuromyelitis Optica
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases