Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury

Study Overview
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Brief Summary
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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 cord injury

Official Title
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Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Conventional Treatment
* Drug: Lithium Carbonate Tablet
* Biological: Cord Blood Cell
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group C - Cord blood cell<br>Conventional treatment, cord blood cell transplant and placebo | Procedure: Conventional Treatment<br>* Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury<br>Biological: Cord Blood Cell<br>* Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site<br>Other: Placebo<br>* Placebo tablet, orally administration of placebo for 6 weeks<br>|
| Placebo Comparator: Group A - Control<br>Conventional treatment and placebo | Procedure: Conventional Treatment<br>* Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury<br>Other: Placebo<br>* Placebo tablet, orally administration of placebo for 6 weeks<br>|
| Experimental: Group B - Lithium Carbonate<br>Conventional treatment and lithium carbonate | Procedure: Conventional Treatment<br>* Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury<br>Drug: Lithium Carbonate Tablet<br>* 250mg/tablet, administrated orally for 6 weeks.<br>|
| Experimental: Group D - Combination Therapy<br>Conventional treatment, cell transplant and 6-weeks course of lithium carbonate | Procedure: Conventional Treatment<br>* Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury<br>Drug: Lithium Carbonate Tablet<br>* 250mg/tablet, administrated orally for 6 weeks.<br>Biological: Cord Blood Cell<br>* Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in AIS Motor and sensory scores and ASIA Impairment Scales in 48 weeks |  | Week 0, 1, 2, 6, 14, 24 and 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking | Walking Index of Spinal Cord Injury (WISCI) | Week 2, 6, 14, 24, 48 | 
| Functional assessment | Spinal Cord Injury Measure (SCIM) Score | Week 2, 6, 14, 24, 48 | 
| Locomotion | Kunming locomotor scales | Week 2, 6, 14, 24, 48 | 
| Spasticity grade | Modified Ashworth Scale | Week 2, 6, 14, 24, 48 | 
| Pain | Numerical rating scales | Week 2, 6, 14, 24, 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, umbilical cord blood cell, cell transplant, lithium carbonate