Spinal Cord InjuriesNCT00517374
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
An observational study of Spinal Cord Injuries, run by China Spinal Cord Injury Network at 17 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 600 participants
- Where
- 17 sitesChina
- Study dates
- Sep 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 4. Has a chronic SCI (defined as > 12 months post-initial SCI surgery)
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Army General Hospital
Beijing
Beijing University People's Hospital
Beijing
Beijing Xishan Hospital
Beijing
China Rehabilitation Research Center
Beijing
Nanfang Hospital
Guangzhou
Second Affliliated Hospital of Sun Yat-sen University
Guangzhou
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Chengdu Army Kuming General Hospital
Kunming
Ningbo Second People Hospital
Ningbo, Zhejiang
Changhai Hospital
Shanghai
Shanghai East Hospital
Shanghai
Zhongshan Hospital
Shanghai
First Affiliated Hospital of Medical College, Shantou University
Shantou, Guangdong
Tianjin Medical University Hospital
Tianjin
Xian Jiaotong University Second Hospital
Xi'an
Xijing Hospital
Xi'an
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Spinal Cord Injury Network
- Sponsor type
- Research network
- Collaborators
- The University of Hong Kong
- Investigators
- Wise Young, MD, PhD, Study director, Unaffilated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517374
- Sponsor's protocol ID
- CN100
- Status last verified
- Sep 2015
- First submitted
- 15 Aug 2007
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
- ClinicalTrials.gov ID
- NCT00517374
- Acronym / sponsor ID
- CN100
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- China Spinal Cord Injury NetworkResearch network
- Collaborators
- The University of Hong Kong
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
- Has an acute SCI (defined as < 7 days post-injury)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wise Young, MD, PhD study director
Unaffilated
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by China Spinal Cord Injury Network at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.