Stem Cell Therapy in Traumatic Brain Injury
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 25, 2018
October 1, 2018
6.3 years
January 3, 2014
October 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in clinical symptoms of traumatic brain injury
6 months
Secondary Outcomes (1)
Disability Rating scale
6 months
Other Outcomes (1)
SF-8 scale
6 months
Study Arms (1)
stem cells
EXPERIMENTALautologous bone marrow mononuclear cell transplantation
Interventions
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
Eligibility Criteria
You may qualify if:
- Diagnosed cases of chronic traumatic brain injury
- Age above 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurogen brain and spine institute
Mumbai, Maharashtra, 400071, India
Related Publications (2)
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.
PMID: 23180314BACKGROUNDTian 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.
PMID: 22891928BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alok K Sharma, M.S., M.Ch
Neurogen Brain and Spine Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2014
First Posted
January 6, 2014
Study Start
January 1, 2010
Primary Completion
April 1, 2016
Study Completion
September 1, 2016
Last Updated
October 25, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share