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

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT00517374
First received: August 15, 2007
Last updated: January 2, 2008
Last verified: January 2008

August 15, 2007
January 2, 2008
September 2005
December 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00517374 on ClinicalTrials.gov Archive Site
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A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Spinal Cord Injuries
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00517374
CN100
No
Director, Clinical Trial Centre, The University of Hong Kong
China Spinal Cord Injury Network
The University of Hong Kong
Study Director: Wise Young, MD, PhD Unaffilated
China Spinal Cord Injury Network
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP