Clinical trial NCT02260713: Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.
Official title: Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Spinal Cord Injury
Lead sponsor: Indian Spinal Injuries Centre
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2014-10-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

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.

Primary outcomes:
measure: Examine for improvement in the ASIA classification.
timeFrame: 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
timeFrame: up to 5 years
measure: Improvement by at least 1 point on the WISCI scale
timeFrame: up to 5 years
measure: Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale
timeFrame: up to 5 years
measure: Improvement in ASIA sensory examination
timeFrame: up to 5 years
measure: Improvements in SCIM score
timeFrame: up to 5 years
measure: Psychological evaluation
timeFrame: up to 5 years
measure: Improvements in EMG
timeFrame: up to 5 years
measure: Improvements in SSEP
timeFrame: up to 5 years
measure: Improvements in MEP
timeFrame: up to 5 years
measure: Significant change in any of the variables included in urodynamic assessment
timeFrame: up to 5 years
measure: Improvements in any of the variables included in ISCIS
timeFrame: up to 5 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Indian Spinal Injury Center
state: Delhi
Study officials:
affiliation: Indian Spinal Injuries Centre
name: Dr Harvinder S Chhabra, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chhabra HS, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, Sangodimath GM, Tandon V. Autologous bone marrow cell transplantation in acute spinal cord injury--an Indian pilot study. Spinal Cord. 2016 Jan;54(1):57-64. doi: 10.1038/sc.2015.134. Epub 2015 Aug 18.