Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica
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|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
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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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.
- Score of Expanded Disability Status Scale (EDSS) [ Time Frame: 1 year after treatment ]
- Visual Evoked Potential (VEP) [ Time Frame: 1 year after treatment ]
- Brainstem Auditory Evoked Potential (BAEP) [ Time Frame: 1 year after treatment ]
- Somatosensory Evoked Potential(SEP) [ Time Frame: 1 year after treatment ]
- Brain Magnetic Resonance Imaging （MRI） Scan [ Time Frame: 1 year after treatment ]
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- Enrollment in other trials in the last 3 months.
- Other criteria the investigator consider improper for inclusion.
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
|Contact: Yun Yun Xufirstname.lastname@example.org|
|Nanjing University Medical College Affiliated Drum Tower Hospital||Recruiting|
|Nanjing, Jiangsu, China|
|Contact: Yun Xu email@example.com|
|Responsible Party:||Shenzhen Beike Bio-Technology Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||June 2, 2011 Key Record Dates|
|Last Update Posted:||November 28, 2012|
|Last Verified:||November 2012|
Progressive Multiple Sclerosis
Umbilical Cord Mesenchymal Stem Cell
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases