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| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
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Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and feasibility of autologous bone marrow cell transplantation in case of acute complete spinal cord injury by each of the following techniques and a corresponding number of controlled subjects:
Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow cell transplantation through one of the below mentioned techniques: 1. Directly into the injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone marrow harvesting, enrichment and transplantation was completed in a single setting of approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins per injection site that is approximately 12 mins and in case of lumbar puncture the transplantation procedure took approximately 2 mins.
Comparator Agent:Control: control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation. | |
| Transplantation via intrathecal route | Experimental | Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture |
|
| Transplantation via intralesional route | Experimental | Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous bone marrow cell | Biological | Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Examine for improvement in the ASIA classification. | Blinded assessors will examine for improvement in the ASIA classification of at least one grade by 12 months or change from baseline of 10 points or more in total motor score, with consideration of their distribution along the neuraxis, from the ASIA Impairment Scale (AIS) manual motor test by 12 months. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury | up to 5 years | |
| Improvement by at least 1 point on the WISCI scale | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Harvinder S Chhabra, MS | Indian Spinal Injuries Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indian Spinal Injury Center | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26282492 | Result | Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18. |
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| Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale | up to 5 years |
| Improvement in ASIA sensory examination | up to 5 years |
| Improvements in SCIM score | up to 5 years |
| Psychological evaluation | up to 5 years |
| Improvements in EMG | up to 5 years |
| Improvements in SSEP | up to 5 years |
| Improvements in MEP | up to 5 years |
| Significant change in any of the variables included in urodynamic assessment | up to 5 years |
| Improvements in any of the variables included in ISCIS | up to 5 years |