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The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell | Experimental | autologous bone marrow mononuclear cell transplantation |
|
| Control | No Intervention | Stem cell therapy is not done for this group of spinal cord injury patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow mononuclear cell transplantation | Biological | Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical symptoms of spinal cord injury after 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional independence measure (FIM) | It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alok K Sharma, MS,MCh | Neurogen Brain and Spine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurogen brain and spine institute | Mumbai | Maharashtra | 400071 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sharma A, Gokulchandran N, Sane H, Badhe P, Kulkarni P, Lohia M, Nagrajan A, Thomas N. Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study. Journal of Neurorestoratology. 2013;1:13-22 | ||
| Background | Sharma A, Sane H, Gokulchandran N, Kulkarni P, Thomas N, et al. (2013) Role of Autologous Bone Marrow Mononuclear Cells in Chronic Cervical Spinal Cord Injury-A Longterm Follow Up Study. J Neurol Disord 1: 138. | ||
| 20353375 | Background | Kumar AA, Kumar SR, Narayanan R, Arul K, Baskaran M. Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. Exp Clin Transplant. 2009 Dec;7(4):241-8. | |
| 17600518 |
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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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| Background |
| Yoshihara T, Ohta M, Itokazu Y, Matsumoto N, Dezawa M, Suzuki Y, Taguchi A, Watanabe Y, Adachi Y, Ikehara S, Sugimoto H, Ide C. Neuroprotective effect of bone marrow-derived mononuclear cells promoting functional recovery from spinal cord injury. J Neurotrauma. 2007 Jun;24(6):1026-36. doi: 10.1089/neu.2007.132R. |
| 22507683 | Background | Sharma A, Gokulchandran N, Chopra G, Kulkarni P, Lohia M, Badhe P, Jacob VC. Administration of autologous bone marrow-derived mononuclear cells in children with incurable neurological disorders and injury is safe and improves their quality of life. Cell Transplant. 2012;21 Suppl 1:S79-90. doi: 10.3727/096368912X633798. |
| D014947 | Wounds and Injuries |