Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2008
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedOctober 25, 2018
October 1, 2018
3.7 years
December 18, 2013
October 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in clinical symptoms
clinical symptoms were assessed based on the observation of the experts
6 months
Secondary Outcomes (1)
Functional Independence Measure (FIM)
6 months
Study Arms (1)
Stem cell
EXPERIMENTALAutologous bone marrow mononuclear cell transplantation
Interventions
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
You may qualify if:
- Diagnosed cases of any type of chronic Spinal cord 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
- other acute medical conditions such as respiratory infection
- pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurogen brain and spine institute
Mumbai, Maharashtra, 400071, India
Related Publications (3)
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.
PMID: 20353375BACKGROUNDYoshihara 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.
PMID: 17600518BACKGROUNDSharma 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.
PMID: 22507683BACKGROUND
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
December 18, 2013
First Posted
January 6, 2014
Study Start
December 1, 2008
Primary Completion
August 1, 2012
Study Completion
February 1, 2013
Last Updated
October 25, 2018
Record last verified: 2018-10