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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Spinal Cord Injury
• Intervention / Treatment: Biological: autologous bone marrow cell

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Indian Spinal Injury Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; control subjects with acute complete spinal cord injury who would not receive any bone marrow transplantation.
Experimental: Transplantation via intrathecal route; Subjects with acute complete spinal cord injury who receive autologous bone marrow cell transplantation via lumber puncture	Biological: 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.
Experimental: 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 .	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury	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
Improvement in ASIA sensory examination	up to 5 years
Improvements in SCIM score	up to 5 years
Psychological evaluation	up to 5 years
Improvements in EMG	up to 5 years
Improvements in SSEP	up to 5 years
Improvements in MEP	up to 5 years
Significant change in any of the variables included in urodynamic assessment	up to 5 years
Improvements in any of the variables included in ISCIS	up to 5 years

Collaborators and Investigators

• Sponsor: Indian Spinal Injuries Centre
• Collaborators: Indian Council of Medical Research
• Investigators: Principal Investigator: Dr Harvinder S Chhabra, MS, Indian Spinal Injuries Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: ISIC-BMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No