Acute Spinal Cord Injury
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALautologous bone marrow cell
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.
Sponsors
Indian Council of Medical Research
Indian Spinal Injuries Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Acute spinal cord injury between 10 days and 14 days post injury. 2. The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level). 3. Must have a complete injury (ASIA-A).
Exclusion criteria
1. Subject whose medical condition requires mechanical ventilation. 2. Subjects with neurological level of injury above T1 and below T12. 3. Subjects more than 14 days and less than 10 days post-injury. 4. Lower motor neuron injury. 5. Subjects with pathological fracture. 6. Spinal Injuries in subjects with Ankylosing Spondylitis. 7. Subjects with extremes of age: less than 18 years or more than 50 years. 8. Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis. 9. Subjects with Psychological disorders. 10. Female subjects with pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine for improvement in the ASIA classification. | up to 5 years | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
India
Outcome results
None listed