NCT02260713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 12, 2018

Status Verified

February 1, 2016

Enrollment Period

6.8 years

First QC Date

September 16, 2014

Last Update Submit

March 9, 2018

Conditions

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

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

Transplantation via intrathecal route

EXPERIMENTAL

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

Biological: autologous bone marrow cell

Transplantation via intralesional route

EXPERIMENTAL

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

Interventions

autologous bone marrow cellBIOLOGICAL

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 routeTransplantation via intrathecal route

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Acute spinal cord injury between 10 days and 14 days post injury.
  • The subject must have a traumatic spinal cord injury between the spinal segmental levels T1 and T12 (Neurological Level).
  • Must have a complete injury (ASIA-A).

You may not qualify if:

  • Subject whose medical condition requires mechanical ventilation.
  • Subjects with neurological level of injury above T1 and below T12.
  • Subjects more than 14 days and less than 10 days post-injury.
  • Lower motor neuron injury.
  • Subjects with pathological fracture.
  • Spinal Injuries in subjects with Ankylosing Spondylitis.
  • Subjects with extremes of age: less than 18 years or more than 50 years.
  • Subjects with pre-existing severe medical disease which would affect the outcome like severe diabetes, rheumatoid arthritis.
  • Subjects with Psychological disorders.
  • Female subjects with pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Spinal Injury Center

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related 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 Aug 18.

    PMID: 26282492RESULT

Study Officials

  • Dr Harvinder S Chhabra, MS

    Indian Spinal Injuries Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

October 9, 2014

Study Start

February 1, 2011

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

March 12, 2018

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)