Back to resultsSafety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, autologous bone marrow mononuclear cells, stem cell therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed cases of any type of chronic Spinal cord injury
- Age above 6 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
- other acute medical conditions such as respiratory infection
- pregnancy and lactation
Sites / Locations
- Neurogen brain and spine institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem cell
Arm Description
Autologous bone marrow mononuclear cell transplantation
Outcomes
Primary Outcome Measures
Change in clinical symptoms
clinical symptoms were assessed based on the observation of the experts
Secondary Outcome Measures
Functional Independence Measure (FIM)
Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.
Full Information
NCT ID
NCT02027246
First Posted
December 18, 2013
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
1. Study Identification
Unique Protocol Identification Number
NCT02027246
Brief Title
Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
Official Title
Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.
Detailed Description
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, autologous bone marrow mononuclear cells, stem cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem cell
Arm Type
Experimental
Arm Description
Autologous bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Autologous bone marrow mononuclear cell transplantation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in clinical symptoms
Description
clinical symptoms were assessed based on the observation of the experts
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed cases of any type of chronic Spinal cord injury
Age above 6 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
other acute medical conditions such as respiratory infection
pregnancy and lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok K Sharma, M.S., M.Ch
Organizational Affiliation
Neurogen Brain and Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
20353375
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.
Results Reference
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PubMed Identifier
17600518
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.
Results Reference
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PubMed Identifier
22507683
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.
Results Reference
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Learn more about this trial
Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
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