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Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02027246
Recruitment Status : Withdrawn
First Posted : January 6, 2014
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Autologous bone marrow mononuclear cell transplantation Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury
Study Start Date : December 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : February 2013

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




Primary Outcome Measures :
  1. Change in clinical symptoms [ Time Frame: 6 months ]
    clinical symptoms were assessed based on the observation of the experts


Secondary Outcome Measures :
  1. Functional Independence Measure (FIM) [ Time Frame: 6 months ]
    Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.



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Ages Eligible for Study:   8 Months to 63 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed cases of any type of chronic Spinal cord injury
  • Age above 6 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
  • other acute medical conditions such as respiratory infection
  • pregnancy and lactation

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 ClinicalTrials.gov identifier (NCT number): NCT02027246


Locations
India
Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
Investigators
Principal Investigator: Alok K Sharma, M.S., M.Ch Neurogen Brain and Spine Institute