Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
NCT ID: NCT01471613
Last Updated: 2014-01-28
Study Results
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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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2011-09-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group C - Cord blood cell
Conventional treatment, cord blood cell transplant and placebo
Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Cord Blood Cell
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
Placebo
Placebo tablet, orally administration of placebo for 6 weeks
Group A - Control
Conventional treatment and placebo
Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Placebo
Placebo tablet, orally administration of placebo for 6 weeks
Group B - Lithium Carbonate
Conventional treatment and lithium carbonate
Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Lithium Carbonate Tablet
250mg/tablet, administrated orally for 6 weeks.
Group D - Combination Therapy
Conventional treatment, cell transplant and 6-weeks course of lithium carbonate
Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Lithium Carbonate Tablet
250mg/tablet, administrated orally for 6 weeks.
Cord Blood Cell
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
Interventions
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Conventional Treatment
Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
Lithium Carbonate Tablet
250mg/tablet, administrated orally for 6 weeks.
Cord Blood Cell
Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
Placebo
Placebo tablet, orally administration of placebo for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Chengdu PLA General Hospital
OTHER
StemCyte, Inc.
INDUSTRY
China Spinal Cord Injury Network
NETWORK
Responsible Party
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Principal Investigators
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Hui Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Chengdu PLA General Hospital
Locations
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Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital
Kunming, Yunnan, China
Countries
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Other Identifiers
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CN102c
Identifier Type: -
Identifier Source: org_study_id
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