A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
NCT ID: NCT00517374
Last Updated: 2015-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2005-09-30
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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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
18 Years
65 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
China Spinal Cord Injury Network
NETWORK
Responsible Party
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Clinical Trial Centre, The University of Hong Kong
Principal Investigators
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Wise Young, MD, PhD
Role: STUDY_DIRECTOR
Unaffilated
Locations
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First Affiliated Hospital of Medical College, Shantou University
Shantou, Guangdong, China
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
Xi'an, , China
Xijing Hospital
Xi'an, , China
Countries
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Other Identifiers
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CN100
Identifier Type: -
Identifier Source: org_study_id
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