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

Phase 1

Completed

• Conditions: Acute Spinal Cord Injury
• Interventions: Biological: autologous bone marrow cell

• Registration Number: NCT02260713
• Lead Sponsor: Indian Spinal Injuries Centre

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Status Verified: 2016-02
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transplantation via intrathecal route	autologous bone marrow cell	Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture
Transplantation via intralesional route	autologous bone marrow cell	Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via durotomy and injection at the lesional site .

Primary Outcome Measures

Name	Time	Method
Examine for improvement in the ASIA classification.	up to 5 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indian Spinal Injury Center; 🇮🇳 New Delhi, Delhi, India