Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2010-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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stem cells
autologous bone marrow mononuclear cell transplantation
Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
Interventions
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Autologous bone marrow mononuclear cell transplantation
bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
Eligibility Criteria
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Inclusion Criteria
* Age above 6 months
Exclusion Criteria
* 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
6 Months
65 Years
ALL
No
Sponsors
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Neurogen Brain and Spine Institute
OTHER
Responsible Party
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Principal Investigators
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Alok K Sharma, M.S., M.Ch
Role: PRINCIPAL_INVESTIGATOR
Neurogen Brain and Spine Institute
Locations
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Neurogen brain and spine institute
Mumbai, Maharashtra, India
Countries
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References
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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.
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.
Other Identifiers
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NGBSI-06
Identifier Type: -
Identifier Source: org_study_id
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