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Stem Cell Therapy in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Withdrawn
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, stem cell therapy, bone marrow, mononuclear cells, autologous

Eligibility Criteria

12 Months - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stem cell

Control

Arm Description

autologous bone marrow mononuclear cell transplantation

Stem cell therapy is not done for this group of spinal cord injury patients

Outcomes

Primary Outcome Measures

Change in clinical symptoms of spinal cord injury after 6 months

Secondary Outcome Measures

Functional independence measure (FIM)
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.

Full Information

First Posted
December 2, 2013
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02009124
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

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 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.

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, stem cell therapy, bone marrow, mononuclear cells, autologous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell
Arm Type
Experimental
Arm Description
autologous bone marrow mononuclear cell transplantation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Stem cell therapy is not done for this group of spinal cord injury patients
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 of spinal cord injury after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional independence measure (FIM)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok K Sharma, MS,MCh
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:
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
Results Reference
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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.
Results Reference
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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

Stem Cell Therapy in Spinal Cord Injury

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