Text Size

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
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Resource links provided by NLM:

U.S. FDA Resources

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

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517374

Locations
China, Guangzhou
First Affiliated Hospital of Medical College, Shantou University
Shantou, Guangzhou, China
China, Zhjiang
Ningbo Second People Hospital
Ningbo, Zhjiang, China
China
China Rehabilitation Research Center
Beijing, China
Beijing Army General Hospital
Beijing, China
Beijing University People's Hospital
Beijing, China
Beijing Xishan Hospital
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
Shanghai East Hospital
Shanghai, China
Zhongshan Hospital
Shanghai, China
Changhai Hospital
Shanghai, China
Tianjin Medical University Hospital
Tianjin, China
Xijing Hospital
Xian, China
Xian Jiaotong University Second Hospital
Xian, China
Sponsors and Collaborators
China Spinal Cord Injury Network
The University of Hong Kong
Investigators
Study Director: Wise Young, MD, PhD Unaffilated
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Centre, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00517374     History of Changes
Other Study ID Numbers: CN100
Study First Received: August 15, 2007
Last Updated: January 2, 2008
Health Authority: Hong Kong: Ethics Committee
China: Ethics Committee

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013