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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01364246
Other study ID # BKCR-MS-1.0(2010)
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received May 31, 2011
Last updated November 26, 2012
Start date January 2010
Est. completion date December 2014

Study information

Verified date November 2012
Source Shenzhen Beike Bio-Technology Co., Ltd.
Contact Yun Yun Xu
Email xuyun20042001@yahoo.com.cn
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2014
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.

Locations

Country Name City State
China Nanjing University Medical College Affiliated Drum Tower Hospital Nanjing Jiangsu

Sponsors (6)

Lead Sponsor Collaborator
Shenzhen Beike Bio-Technology Co., Ltd. Nanjing University Medical College Affiliated Wuxi Second Hospital, The Affiliated Nanjing Brain Hospital of Nanjing University Medical School, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Hospital of Nanjing Medical University, Xuzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of Expanded Disability Status Scale (EDSS) 1 year after treatment No
Secondary Visual Evoked Potential (VEP) 1 year after treatment No
Secondary Brainstem Auditory Evoked Potential (BAEP) 1 year after treatment No
Secondary Somatosensory Evoked Potential(SEP) 1 year after treatment No
Secondary Brain Magnetic Resonance Imaging (MRI) Scan 1 year after treatment No
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