Stem Cell Therapy in Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Neurogen Brain and Spine Institute
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT02028104
First received: January 3, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability Rating scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • SF-8 scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   6 Months to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028104

Contacts
Contact: Alok K Sharma, M.S, M.Ch 91-22-25281610 alok276@gmail.com

Locations
India
Neurogen brain and spine institute Recruiting
Mumbai, Maharashtra, India, 400071
Contact: Alok K Sharma, M.S, M.Ch.    91-22-25281610    alok276@gmail.com   
Sponsors and Collaborators
Neurogen Brain and Spine Institute
Investigators
Principal Investigator: Alok K Sharma, M.S., M.Ch Neurogen Brain and Spine Institute
  More Information

Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02028104     History of Changes
Other Study ID Numbers: NGBSI-06
Study First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: India: Indian Council of Medical Research

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

ClinicalTrials.gov processed this record on August 21, 2014