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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 November 2012 by Shenzhen Beike Bio-Technology Co., Ltd.
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
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
First received: May 31, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes

May 31, 2011
November 26, 2012
January 2010
March 2013   (final data collection date for primary outcome measure)
Score of Expanded Disability Status Scale (EDSS) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364246 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Progressive Multiple Sclerosis
  • Neuromyelitis Optica.
Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Intervention group
Intervention: Biological: human umbilical cord mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2014
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Yun Yun Xu xuyun20042001@yahoo.com.cn
China
 
NCT01364246
BKCR-MS-1.0(2010)
Yes
Shenzhen Beike Bio-Technology Co., Ltd.
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
Not Provided
Shenzhen Beike Bio-Technology Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP