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A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

This study has been completed.

Sponsors and Collaborators: China Spinal Cord Injury Network
The University of Hong Kong
Information provided by: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT00517374
  Purpose

To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI therapies in forthcoming randomised controlled multi-centre clinical trials following international standards and guidelines.


Condition
Spinal Cord Injuries

MedlinePlus related topics:   Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Further study details as provided by China Spinal Cord Injury Network:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   600
Study Start Date:   September 2005
Study Completion Date:   December 2007
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

This is a multicentre, observational, registry study of outcome data on SCI patients in Mainland China and Hong Kong. The target population consists of patients who have a SCI, where acute SCI is defined as <7 days post-injury and chronic SCI is defined as >12 months post-initial SCI surgery.

A total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in Mainland China (namely: Beijing, Shanghai, Guangzhou, NingBo, Xi'an and Kunming) and Hong Kong. The duration of the study will be one year, with a total of 4 visits.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Each study enrolled Hospital in China and Hong Kong is expected to recruit 20 chronic spinal cord injury patients, who have never had any cell therapy treatment for spinal cord injur before.


Criteria

Inclusion Criteria:

General

  1. Male or female adult subjects, 18 to 65 years of age
  2. Have a clinical diagnosis of SCI, defined by MRI
  3. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures

    Acute SCI Study Group:

  4. Has an acute SCI (defined as < 7 days post-injury)

Chronic SCI Study Group:

4. Has a chronic SCI (defined as > 12 months post-initial SCI surgery)

Exclusion Criteria:

General

  1. Severe head injury
  2. Is medically or mentally unstable according to the judgement of the Investigator
  3. History of Multiple Sclerosis or peripheral demyelinating disease
  4. Likely to have experimental therapy
  5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517374

Locations
China
Beijing Army General Hospital    
      Beijing, China
Beijing University People's Hospital    
      Beijing, China
China Rehabilitation Research Center    
      Beijing, China
Beijing Xishan Hospital    
      Beijing, China
Second Affliliated Hospital of Sun Yat-sen University    
      Guangzhou, China
Shanghai East Hospital    
      Shanghai, China
Zhongshan Hospital    
      Shanghai, China
Changhai Hospital    
      Shanghai, China
Nanfang Hospital    
      Guangzhou, China
Xijing Hospital    
      Xian, China
Xian Jiaotong University Second Hospital    
      Xian, China
Chengdu Army Kuming General Hospital    
      Kunming, China
Queen Mary Hospital    
      Hong Kong, China
Prince of Wales Hospital    
      Hong Kong, China
Tianjin Medical University Hospital    
      Tianjin, China
China, Guangzhou
First Affiliated Hospital of Medical College, Shantou University    
      Shantou, Guangzhou, China
China, Zhjiang
Ningbo Second People Hospital    
      Ningbo, Zhjiang, China

Sponsors and Collaborators
China Spinal Cord Injury Network
The University of Hong Kong

Investigators
Study Director:     Wise Young, MD, PhD     Unaffilated    
  More Information


Responsible Party:   Clinical Trial Centre, The University of Hong Kong ( Director )
Study ID Numbers:   CN100
First Received:   August 15, 2007
Last Updated:   January 2, 2008
ClinicalTrials.gov Identifier:   NCT00517374
Health Authority:   Hong Kong: Ethics Committee;   China: Ethics Committee

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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