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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517374
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : September 25, 2015
The University of Hong Kong
Information provided by:
China Spinal Cord Injury Network

Brief Summary:
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 or disease
Spinal Cord Injuries

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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:


  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:


  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00517374

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China, Guangdong
First Affiliated Hospital of Medical College, Shantou University
Shantou, Guangdong, China
China, Zhejiang
Ningbo Second People Hospital
Ningbo, Zhejiang, China
Beijing Army General Hospital
Beijing, China
Beijing University People's Hospital
Beijing, China
Beijing Xishan Hospital
Beijing, China
China Rehabilitation Research Center
Beijing, China
Nanfang Hospital
Guangzhou, China
Second Affliliated Hospital of Sun Yat-sen University
Guangzhou, China
Prince of Wales Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Chengdu Army Kuming General Hospital
Kunming, China
Changhai Hospital
Shanghai, China
Shanghai East Hospital
Shanghai, China
Zhongshan Hospital
Shanghai, China
Tianjin Medical University Hospital
Tianjin, China
Xian Jiaotong University Second Hospital
Xian, China
Xijing Hospital
Xian, China
Sponsors and Collaborators
China Spinal Cord Injury Network
The University of Hong Kong
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Study Director: Wise Young, MD, PhD Unaffilated

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Responsible Party: Director, Clinical Trial Centre, The University of Hong Kong Identifier: NCT00517374     History of Changes
Other Study ID Numbers: CN100
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System