Acute Spinal Cord Injury Clinical Trial
Official title:
Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
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:
- Directly into the injured site with a syringe after exposing the spinal cord.
- By Intrathecal injection.
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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