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

Acute Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260713
• Other study ID #: ISIC-BMC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 16, 2014
• Last updated: March 9, 2018
• Start date: February 2011
• Est. completion date: November 2017

Study information

• Verified date: February 2016
• Source: Indian Spinal Injuries Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
India	Indian Spinal Injury Center	New Delhi	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Indian Spinal Injuries Centre	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

References & Publications (1)

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 Au — View Citation

Outcome

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