Status:
COMPLETED
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
Lead Sponsor:
China Spinal Cord Injury Network
Collaborating Sponsors:
Chengdu PLA General Hospital
StemCyte, Inc.
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cor...
Eligibility Criteria
Inclusion
- either gender and 18-65 years old;
- acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks);
- neurological status of ASIA A;
- neurological level between C5-T11;
- MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter;
- professional judgment determinate that subjects need a spinal decompression surgery;
- subjects able to complete neurological examination;
- subjects have voluntarily signed and dated an informed consent form.
Exclusion
- penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions;
- spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord;
- severe complications;
- significant medical diseases or infection;
- pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study;
- unavailability of suitable umbilical cord blood cells;
- contraindication of lithium carbonate and/or spinal decompression surgery
- subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening;
- investigator suggests that the subject would not be suitable to participate this study
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01471613
Start Date
September 1 2011
End Date
January 1 2014
Last Update
January 28 2014
Active Locations (1)
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1
Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
Kunming, Yunnan, China, 650032