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

NCT ID: NCT02260713

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-11-30

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.

Conditions

Acute Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Transplantation via intrathecal route

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

Group Type: EXPERIMENTAL

autologous bone marrow cell

Intervention Type: BIOLOGICAL

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.

Transplantation via intralesional route

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

Group Type: EXPERIMENTAL

autologous bone marrow cell

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Indian Spinal Injuries Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Harvinder S Chhabra, MS

Role: PRINCIPAL_INVESTIGATOR

Indian Spinal Injuries Centre

Locations

Indian Spinal Injury Center

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 26282492 (View on PubMed)

Other Identifiers

ISIC-BMC

Identifier Type: -

Identifier Source: org_study_id