Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273364
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2006-01-05
Brief Title:
Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy A Randomized Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple sclerosis MS is at onset an immune-mediated demyelinating disease In most cases it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares Over years or decades virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies while immune based therapies are generally ineffective in patients with a progressive clinical course This clinical course and response to immune suppression as well as neuropathology and neuroimaging studies suggest that disease progression is associated with axonal atrophy Disability correlates better with measures of axonal atrophy than immune mediated demyelination Therefore immune based therapies in order to be effective need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease While current immune based therapies delay disability no intervention has been proven to prevent progressive disability We propose as a randomized study autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin rATG versus FDA approved standard of care ie interferon glatiramer acetate mitoxantrone natalizumab fingolimod or tecfidera in patients with inflammatory relapsing MS despite treatment with alternate approved therapy
Detailed Description:
To assess the efficacy of autologous PBSCT versus FDA approved standard of care ie interferon glatiramer acetate mitoxantrone natalizumab fingolimod or tecfidera for inflammatory multiple sclerosis MS failing failing alternate approved therapy The endpoints to be considered in this study are
21 Primary Endpoint
Disease progression defined as a 1 point increase in the Expanded Disability Status Scale EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process Patients will be followed for 5 years after randomization
21 Primary Endpoint
Disease progression defined as a 1 point increase in the Expanded Disability Status Scale EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process Patients will be followed for 5 years after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None