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. (see Contacts and Locations)
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
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
  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:


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 2014
Estimated Primary Completion Date: March 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: November 26, 2012
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:
Neuromyelitis Optica
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Cranial Nerve Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Eye Diseases
Immune System Diseases
Myelitis, Transverse
Nervous System Diseases
Optic Nerve Diseases
Optic Neuritis
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014