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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-08-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stem cell
autologous bone marrow mononuclear cell transplantation
Autologous bone marrow mononuclear cell transplantation
Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
Control
Stem cell therapy is not done for this group of spinal cord injury patients
No interventions assigned to this group
Interventions
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Autologous bone marrow mononuclear cell transplantation
Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
Eligibility Criteria
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Inclusion Criteria
* age above 12 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.
12 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, MS,MCh
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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Sharma A, Gokulchandran N, Sane H, Badhe P, Kulkarni P, Lohia M, Nagrajan A, Thomas N. Detailed analysis of the clinical effects of cell therapy for thoracolumbar spinal cord injury: an original study. Journal of Neurorestoratology. 2013;1:13-22
Sharma A, Sane H, Gokulchandran N, Kulkarni P, Thomas N, et al. (2013) Role of Autologous Bone Marrow Mononuclear Cells in Chronic Cervical Spinal Cord Injury-A Longterm Follow Up Study. J Neurol Disord 1: 138.
Kumar AA, Kumar SR, Narayanan R, Arul K, Baskaran M. Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. Exp Clin Transplant. 2009 Dec;7(4):241-8.
Yoshihara T, Ohta M, Itokazu Y, Matsumoto N, Dezawa M, Suzuki Y, Taguchi A, Watanabe Y, Adachi Y, Ikehara S, Sugimoto H, Ide C. Neuroprotective effect of bone marrow-derived mononuclear cells promoting functional recovery from spinal cord injury. J Neurotrauma. 2007 Jun;24(6):1026-36. doi: 10.1089/neu.2007.132R.
Sharma A, Gokulchandran N, Chopra G, Kulkarni P, Lohia M, Badhe P, Jacob VC. Administration of autologous bone marrow-derived mononuclear cells in children with incurable neurological disorders and injury is safe and improves their quality of life. Cell Transplant. 2012;21 Suppl 1:S79-90. doi: 10.3727/096368912X633798.
Other Identifiers
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NGBSI-03
Identifier Type: -
Identifier Source: org_study_id
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