A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

NCT ID: NCT00592722

Last Updated: 2009-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-03-31

Brief Summary

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To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Male or female adult subjects, 18 to 60 years of age;
2. Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
3. The diagnosis of SCI was confirmed by MRI; and
4. 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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

China Spinal Cord Injury Network

NETWORK

Sponsor Role lead

Responsible Party

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Clinical Trial Centre, The University of Hong Kong

Principal Investigators

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Wise Young, MD, PhD

Role: STUDY_DIRECTOR

The University of Hong Kong

Locations

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First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status

301 Orthopedic Hospital

Beijing, , China

Site Status

Second Affiliated Hospital of Third Military Medcial University

Chongqing, , China

Site Status

Buddhist Tzu Chi General Hospital

Hualien City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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China Taiwan

Other Identifiers

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CN100b

Identifier Type: -

Identifier Source: org_study_id

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