Clinical trial NCT02009124: Stem Cell Therapy in Spinal Cord Injury
Official title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
stem cell therapy
bone marrow
mononuclear cells
autologous
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.

Detailed description: Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of any type of spinal cord injury
* age above 12 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.

Primary outcomes:
measure: Change in clinical symptoms of spinal cord injury after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Functional independence measure (FIM)
timeFrame: 6 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
affiliation: Neurogen Brain and Spine Institute
name: Alok K Sharma, MS,MCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.