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Stem Cell Therapy in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02028104
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Brief Summary:
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury
Study Start Date : January 2010
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: stem cells
autologous bone marrow mononuclear cell transplantation
Biological: Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients




Primary Outcome Measures :
  1. Change in clinical symptoms of traumatic brain injury [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Disability Rating scale [ Time Frame: 6 months ]

Other Outcome Measures:
  1. SF-8 scale [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed cases of chronic traumatic brain 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
  • space occupying lesion in brain
  • other acute medical conditions such as respiratory infection and pyrexia
  • pregnancy
  • 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): NCT02028104


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

Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02028104     History of Changes
Other Study ID Numbers: NGBSI-06
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System