Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous bone marrow-derived mononuclear cells | Experimental | Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection in acute phase. Each included patient will receive a single dose of 100 million autologous bone marrow-derived mononuclear cells. |
|
| Control | Placebo Comparator | Included patients will receive the same amount of saline through lumbar injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow-derived mononuclear cells | Biological | Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Spinal Injury Association (ASIA) Impairment Scale | Change in sensory and motor function as measured by the American Spinal Injury Association (ASIA) Impairment Scale. The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal). | baseline, 1 month, 3 months, 6 months and 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Any abnormal signs, symptoms, findings, or diseases that emerge or worsen relative to baseline in 1 month post-treatment will be recorded as adverse event | 1 month post-treatment |
| Motor Evoked Potentials (MEP) and Somatosensory Evoked Potentials (SSEP) test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhua Lu, M.D. | Contact | 86-21-81885793 | xuhualu@hotmail.com | |
| Bangke Zhang, M.D. | Contact | 8618301783716 | zbk12345@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuhua Lu | Shanghai Changzheng Hospotal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | 200003 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
A 2:1 ratio of randomization (intervention group: control group) was used.
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Included patients will receive the same amount of saline through lumbar injection. |
|
Change in sensory and motor function will be measured by SSEP and MED test |
| baseline, 3 months, 6 months and 12 months post-treatment |
| Residual urine test | Change in residual urine as measured by ultrasound test | baseline, 3 months, 6 months and 12 months post-treatment |
| D014947 | Wounds and Injuries |