Clinical trial NCT00517374: A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
Official title: A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: China Spinal Cord Injury Network
Sponsor class: NETWORK
Collaborators: name: The University of Hong Kong
First posted: 2007-08-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: First Affiliated Hospital of Medical College, Shantou University
state: Guangdong
city: Ningbo
country: China
facility: Ningbo Second People Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Army General Hospital
city: Beijing
country: China
facility: Beijing University People's Hospital
city: Beijing
country: China
facility: Beijing Xishan Hospital
city: Beijing
country: China
facility: China Rehabilitation Research Center
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: Second Affliliated Hospital of Sun Yat-sen University
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Kunming
country: China
facility: Chengdu Army Kuming General Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Hospital
city: Xian
country: China
facility: Xian Jiaotong University Second Hospital
city: Xian
country: China
facility: Xijing Hospital
Study officials:
affiliation: Unaffilated
name: Wise Young, MD, PhD
role: STUDY_DIRECTOR
References: