Stem Cell Therapy in Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Neurogen Brain and Spine Institute
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT02009124
First received: December 2, 2013
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.


Condition Intervention Phase
Spinal Cord Injury
Biological: Autologous bone marrow mononuclear cell transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Neurogen Brain and Spine Institute:

Primary Outcome Measures:
  • Change in clinical symptoms of spinal cord injury after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional independence measure (FIM) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention.


Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cell
autologous bone marrow mononuclear cell transplantation
Biological: Autologous bone marrow mononuclear cell transplantation
Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
No Intervention: Control
Stem cell therapy is not done for this group of spinal cord injury patients

Detailed Description:

Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

  Eligibility

Ages Eligible for Study:   12 Months to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed cases of any type of spinal cord injury
  • age above 12 months.

Exclusion Criteria:

  • presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
  • malignancies
  • bleeding tendencies
  • pneumonia
  • renal failure
  • severe liver dysfunction
  • severe anemia [Hemoglobin < 8]
  • any bone marrow disorder
  • space occupying lesion in brain
  • other acute medical conditions such as respiratory infection and pyrexia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009124

Contacts
Contact: Alok K Sharma, M.S, M.Ch 02225281610 alok276@gmail.com

Locations
India
Neurogen brain and spine institute Recruiting
Mumbai, Maharashtra, India, 400071
Contact: Alok k Sharma, M.S, M.Ch.    91-22-25281610    alok276@gmail.com   
Sponsors and Collaborators
Neurogen Brain and Spine Institute
Investigators
Principal Investigator: Alok K Sharma, MS,MCh Neurogen Brain and Spine Institute
  More Information

Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02009124     History of Changes
Other Study ID Numbers: NGBSI-03
Study First Received: December 2, 2013
Last Updated: December 6, 2013
Health Authority: India: Indian Council of Medical Research

Keywords provided by Neurogen Brain and Spine Institute:
spinal cord injury
stem cell therapy
bone marrow
mononuclear cells
autologous

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014