A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

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.

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.

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