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:
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
First received: May 31, 2011
Last updated: November 26, 2012
Last verified: November 2012
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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
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: | 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:
|
Myelitis, Transverse 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 Optic Neuritis Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013