Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.

Study Overview
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Brief Summary
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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: Directly into the injured site with a syringe after exposing the spinal cord. By Intrathecal injection.

Detailed Description
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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.

Official Title
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Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study

Conditions
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Acute Spinal Cord Injury

Intervention / Treatment
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* Biological: autologous bone marrow cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute spinal cord injury between 10 days and 14 days post injury. The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level). Must have a complete injury (ASIA-A). Exclusion Criteria: Subject whose medical condition requires mechanical ventilation. Subjects with neurological level of injury above T1 and below T12. Subjects more than 14 days and less than 10 days post-injury. Lower motor neuron injury. Subjects with pathological fracture. Spinal Injuries in subjects with Ankylosing Spondylitis. Subjects with extremes of age: less than 18 years or more than 50 years. Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis. Subjects with Psychological disorders. Female subjects with pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation. | |
| Experimental: Transplantation via intrathecal route<br>Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture | Biological: autologous bone marrow cell<br>* 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.<br>|
| Experimental: Transplantation via intralesional route<br>Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site . | Biological: autologous bone marrow cell<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |