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Stem Cell Therapy in Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

6 Months - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cells

Arm Description

autologous bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Change in clinical symptoms of traumatic brain injury

Secondary Outcome Measures

Disability Rating scale

Full Information

First Posted
January 3, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02028104
Brief Title
Stem Cell Therapy in Traumatic Brain Injury
Official Title
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stem cells
Arm Type
Experimental
Arm Description
autologous bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow mononuclear cell transplantation
Intervention Description
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
Primary Outcome Measure Information:
Title
Change in clinical symptoms of traumatic brain injury
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disability Rating scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
SF-8 scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok K Sharma, M.S., M.Ch
Organizational Affiliation
Neurogen Brain and Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23180314
Citation
Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24.
Results Reference
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PubMed Identifier
22891928
Citation
Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.
Results Reference
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Learn more about this trial

Stem Cell Therapy in Traumatic Brain Injury

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