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| Name | Class |
|---|---|
| Chengdu PLA General Hospital | OTHER |
| StemCyte, Inc. | INDUSTRY |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C - Cord blood cell | Experimental | Conventional treatment, cord blood cell transplant and placebo |
|
| Group A - Control | Placebo Comparator | Conventional treatment and placebo |
|
| Group B - Lithium Carbonate | Experimental | Conventional treatment and lithium carbonate |
|
| Group D - Combination Therapy | Experimental | Conventional treatment, cell transplant and 6-weeks course of lithium carbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Treatment | Procedure | Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Zhu, MD | Chengdu PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Treating Center of Spinal Cord Injury, Chinese PLA Chengdu Army Kunming General Hospital | Kunming | Yunnan | 650032 | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
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| Lithium Carbonate Tablet | Drug | 250mg/tablet, administrated orally for 6 weeks. |
|
| Cord Blood Cell | Biological | Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site |
|
| Placebo | Other | Placebo tablet, orally administration of placebo for 6 weeks |
|
| 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 |
| D014947 | Wounds and Injuries |
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |