Overview

This trial is active, not recruiting.

Condition acute spinal cord injury
Treatment autologous bone marrow cell
Phase phase 1/phase 2
Sponsor Indian Spinal Injuries Centre
Collaborator Indian Council of Medical Research
Start date February 2011
End date November 2017
Trial size 21 participants
Trial identifier NCT02260713, ISIC-BMC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
(Experimental)
Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture
autologous 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.
(Experimental)
Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .
autologous 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.

Primary Outcomes

Measure
Examine for improvement in the ASIA classification.
time frame: up to 5 years

Secondary Outcomes

Measure
Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury
time frame: up to 5 years
Improvement by at least 1 point on the WISCI scale
time frame: up to 5 years
Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale
time frame: up to 5 years
Improvement in ASIA sensory examination
time frame: up to 5 years
Improvements in SCIM score
time frame: up to 5 years
Psychological evaluation
time frame: up to 5 years
Improvements in EMG
time frame: up to 5 years
Improvements in SSEP
time frame: up to 5 years
Improvements in MEP
time frame: up to 5 years
Significant change in any of the variables included in urodynamic assessment
time frame: up to 5 years
Improvements in any of the variables included in ISCIS
time frame: up to 5 years

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
Principal investigator Dr Harvinder S Chhabra, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Indian Spinal Injuries Centre.