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

Indian Spinal Injuries Centre

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Spinal Cord Injury

Treatments: Biological: autologous bone marrow cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02260713

ISIC-BMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Control

No Intervention group

Description:

control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.

Transplantation via intrathecal route

Experimental group

Description:

Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture

Treatment:

Biological: autologous bone marrow cell

Transplantation via intralesional route

Experimental group

Description:

Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .

Treatment:

Biological: autologous bone marrow cell