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Stem Cell Therapy in Traumatic Brain Injury

This study has been completed.
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute Identifier:
First received: January 3, 2014
Last updated: September 23, 2016
Last verified: September 2016
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

Condition Intervention Phase
Traumatic Brain Injury
Biological: Autologous bone marrow mononuclear cell transplantation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain 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 traumatic brain injury [ Time Frame: 6 months ]

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

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

Enrollment: 43
Study Start Date: January 2010
Study Completion Date: September 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02028104

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

Responsible Party: Neurogen Brain and Spine Institute Identifier: NCT02028104     History of Changes
Other Study ID Numbers: NGBSI-06
Study First Received: January 3, 2014
Last Updated: September 23, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on May 25, 2017