A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
1 other identifier
observational
600
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2005
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 15, 2007
CompletedFirst Posted
Study publicly available on registry
August 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedSeptember 25, 2015
September 1, 2015
2.2 years
August 15, 2007
September 24, 2015
Conditions
Eligibility Criteria
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.
You may qualify if:
- General
- Male or female adult subjects, 18 to 65 years of age
- Have a clinical diagnosis of SCI, defined by MRI
- 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:
- Has an acute SCI (defined as \< 7 days post-injury)
- Chronic SCI Study Group:
- \. Has a chronic SCI (defined as \> 12 months post-initial SCI surgery)
You may not qualify if:
- General
- Severe head injury
- Is medically or mentally unstable according to the judgement of the Investigator
- History of Multiple Sclerosis or peripheral demyelinating disease
- Likely to have experimental therapy
- Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Spinal Cord Injury Networklead
- The University of Hong Kongcollaborator
Study Sites (17)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wise Young, MD, PhD
Unaffilated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
August 15, 2007
First Posted
August 16, 2007
Study Start
September 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
September 25, 2015
Record last verified: 2015-09