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

September 24, 2015 updated by: China Spinal Cord Injury Network
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing University People's Hospital
      • Beijing, China
        • China Rehabilitation Research Center
      • Beijing, China
        • Beijing Army General Hospital
      • Beijing, China
        • Beijing Xishan Hospital
      • Guangzhou, China
        • Nanfang Hospital
      • Guangzhou, China
        • Second Affliliated Hospital of Sun Yat-sen University
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • Queen Mary Hospital
      • Kunming, China
        • Chengdu Army Kuming General Hospital
      • Shanghai, China
        • Zhongshan Hospital
      • Shanghai, China
        • Shanghai East Hospital
      • Shanghai, China
        • Changhai Hospital
      • Tianjin, China
        • Tianjin Medical University Hospital
      • Xian, China
        • Xijing Hospital
      • Xian, China
        • Xian Jiaotong University Second Hospital
    • Guangdong
      • Shantou, Guangdong, China
        • First Affiliated Hospital of Medical College, Shantou University
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Ningbo Second People Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Spinal Cord Injury Network

Collaborators

The University of Hong Kong

Investigators

  • Study Director: Wise Young, MD, PhD, Unaffilated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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