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

Indian Spinal Injuries Centre21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Spinal Cord Injury

Interventions

autologous bone marrow cellBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Indian Spinal Injury Center

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

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.

Time frame: up to 5 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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