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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 |
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 |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | 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.
Inclusion Criteria:
General
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:
Chronic SCI Study Group:
4. Has a chronic SCI (defined as > 12 months post-initial SCI surgery)
Exclusion Criteria:
General
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 |
China Spinal Cord Injury Network |
The University of Hong Kong |
Study Director: | Wise Young, MD, PhD | Unaffilated |
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 |
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