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

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

• 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)

Exclusion criteria

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