Stem Cell Therapy in Spinal Cord Injury
October 23, 2018 updated by: Neurogen Brain and Spine Institute
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Spinal Cord Injury
The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400071
- Neurogen brain and spine institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stem cell
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in clinical symptoms of spinal cord injury after 6 months
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alok K Sharma, MS,MCh, Neurogen brain and spine institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
December 2, 2013
First Submitted That Met QC Criteria
December 6, 2013
First Posted (Estimate)
December 11, 2013
Study Record Updates
Last Update Posted (Actual)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGBSI-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.