Health Condition 1: null- Traumatic Acute Complete Spinal Cord Injury T1-T12 ( neurological level)
Conditions
Interventions
Intervention1: 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
Sponsors
Indian Council of Medical Research
Indian Spinal Injuries Centre
Eligibility
Inclusion criteria
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
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, such as those with conus medullaris or cauda equina injuries. 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 |
|---|---|
| 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 AIS manual motor test by 12 months.Timepoint: Six monthly follow up for first two years and then annual follow up for next three years | — |
Secondary
| Measure | Time frame |
|---|---|
| Blinded Assessors will examine for: 1.Voluntary movement in additional muscle groups 2.Walking Index of Spinal Cord Injury (WISCI) 3.Modified Ashworth Spasticity scale 4.ASIA sensory examination 5.Spinal Cord Injury Measure (SCIM) 6.Psychological evaluation 7.Electro Myogram (EMG) 8.Somato Sensory Evoked Potential (SSEP) 9.Motor Evoked Potential (MEP) 10.Urodynamic Study 11.Patient Reported Outcome (PRO) using International Spinal cord Injury Scale (ISCIS)Timepoint: Six monthly follow up for first two years and then annual follow up for next three years | — |
Countries
India
Contacts
Public ContactHarvinder Singh Chhabra
Indian Spinal Injuries Centre
Outcome results
None listed