A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

This study is currently recruiting participants.

Verified by China Spinal Cord Injury Network, August 2008

Sponsors and Collaborators:	China Spinal Cord Injury Network The University of Hong Kong
Information provided by:	China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:	NCT00592722

Purpose

To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines

Condition
Spinal Cord Injuries

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:

The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	140
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospital

Criteria

Inclusion Criteria:

Male or female adult subjects, 18 to 60 years of age;
Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
The diagnosis of SCI was confirmed by MRI; and
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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592722

Locations

China
Second Affiliated Hospital of Third Military Medcial University	Recruiting
Chongqing, China
Contact: Yue Zhou, MD +86 23 6878 8005
Principal Investigator: Yue Zhou, MD
301 Orthopedic Hospital	Not yet recruiting
Beijing, China
Contact: Yan Wang, MD +86 10 8821 9860
Principal Investigator: Yan Wang, MD
China, Fujian
First Affiliated Hospital of Fujian Medical University	Active, not recruiting
Fuzhou, Fujian, China
Taiwan
China Medical University Hospital	Active, not recruiting
Taichung, Taiwan
Buddhist Tzu Chi General Hospital	Active, not recruiting
Hualien, Taiwan

Sponsors and Collaborators

China Spinal Cord Injury Network

The University of Hong Kong

Investigators

Study Director:

Wise Young, MD, PhD

The University of Hong Kong

More Information

Responsible Party:	Clinical Trial Centre, The University of Hong Kong ( Director )
Study ID Numbers:	CN100b
Study First Received:	January 2, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00592722
Health Authority:	China: Ethics Committee; Taiwan: Institutional Review Board

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009