Skip to main content
OpenTrials
Completed

NCT Number: NCT02260713

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Spinal Cord Injury

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Indian Spinal Injury Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

autologous bone marrow cell

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.

Primary outcomes

  1. Examine for improvement in the ASIA classification.

    Time frame: 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 outcomes

  1. Any voluntary movement by additional muscle groups not included in International Standards for Neurological Classification of Spinal Cord Injury

    Time frame: up to 5 years

  2. Improvement by at least 1 point on the WISCI scale

    Time frame: up to 5 years

  3. Decrease in spasticity by one grade or more as assessed by Modified Ashworth Spasticity Scale

    Time frame: up to 5 years

  4. Improvement in ASIA sensory examination

    Time frame: up to 5 years

  5. Improvements in SCIM score

    Time frame: up to 5 years

  6. Psychological evaluation

    Time frame: up to 5 years

  7. Improvements in EMG

    Time frame: up to 5 years

  8. Improvements in SSEP

    Time frame: up to 5 years

  9. Improvements in MEP

    Time frame: up to 5 years

  10. Significant change in any of the variables included in urodynamic assessment

    Time frame: up to 5 years

  11. Improvements in any of the variables included in ISCIS

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Indian Spinal Injuries Centre

Other

Collaborators

  • Indian Council of Medical Research

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2014
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.