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Stem Cell Therapy in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02009124
Recruitment Status : Withdrawn
First Posted : December 11, 2013
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Autologous bone marrow mononuclear cell transplantation Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
Study Start Date : August 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in clinical symptoms of spinal cord injury after 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02009124

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Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
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Principal Investigator: Alok K Sharma, MS,MCh Neurogen Brain and Spine Institute
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Responsible Party: Neurogen Brain and Spine Institute Identifier: NCT02009124    
Other Study ID Numbers: NGBSI-03
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Keywords provided by Neurogen Brain and Spine Institute:
spinal cord injury
stem cell therapy
bone marrow
mononuclear cells
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System