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Stem Cell Therapy in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02009124
Recruitment Status : Recruiting
First Posted : December 11, 2013
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

December 2, 2013
December 11, 2013
September 14, 2017
August 2012
June 2018   (Final data collection date for primary outcome measure)
Change in clinical symptoms of spinal cord injury after 6 months [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT02009124 on ClinicalTrials.gov Archive Site
Functional independence measure (FIM) [ Time Frame: 6 months ]
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.
Same as current
Not Provided
Not Provided
 
Stem Cell Therapy in Spinal Cord Injury
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injury
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
  • Experimental: Stem cell
    autologous bone marrow mononuclear cell transplantation
    Intervention: Biological: Autologous bone marrow mononuclear cell transplantation
  • No Intervention: Control
    Stem cell therapy is not done for this group of spinal cord injury patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2018
June 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months to 65 Years   (Child, Adult)
No
Contact: Alok K Sharma, M.S, M.Ch 02225281610 alok276@gmail.com
India
 
 
NCT02009124
NGBSI-03
Yes
Not Provided
Not Provided
Neurogen Brain and Spine Institute
Neurogen Brain and Spine Institute
Not Provided
Principal Investigator: Alok K Sharma, MS,MCh Neurogen Brain and Spine Institute
Neurogen Brain and Spine Institute
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP