Stem Cell Therapy in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02009124

Recruitment Status : Withdrawn

First Posted : December 11, 2013

Last Update Posted : October 25, 2018

Sponsor:

Information provided by (Responsible Party):

Neurogen Brain and Spine Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Biological: Autologous bone marrow mononuclear cell transplantation	Phase 2

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
Study Start Date :	August 2012
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Stem cell autologous bone marrow mononuclear cell transplantation	Biological: 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
No Intervention: Control Stem cell therapy is not done for this group of spinal cord injury patients

Outcome Measures

Primary Outcome Measures :

Change in clinical symptoms of spinal cord injury after 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :

Functional independence measure (FIM) [ Time Frame: 6 months ]
It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Months to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009124

Locations

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India
Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071

Sponsors and Collaborators

Neurogen Brain and Spine Institute

Investigators

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Principal Investigator:	Alok K Sharma, MS,MCh	Neurogen Brain and Spine Institute

More Information

Publications:

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.

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.

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Responsible Party:	Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:	NCT02009124
Other Study ID Numbers:	NGBSI-03
First Posted:	December 11, 2013 Key Record Dates
Last Update Posted:	October 25, 2018
Last Verified:	October 2018

Keywords provided by Neurogen Brain and Spine Institute:


spinal cord injury stem cell therapy bone marrow mononuclear cells autologous

Additional relevant MeSH terms:

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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases	Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System

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