Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01471613 | Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury | PHASE1 | COMPLETED | 16 | — | — | Sep 1, 2011 | Jan 1, 2014 | Jan 28, 2014 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Conventional Treatment | PROCEDURE | Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury |
| 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 |
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...