Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278486
Status:
TERMINATED
Last Update Posted:
2013-04-08
First Post:
2006-01-15
Brief Title:
Hematopoietic Stem Cell Transplantation in Autoimmune-Related RetinopathyARRON
Sponsor:
Richard Burt MD
Organization:
Northwestern University
Study Overview
Official Title:
Immune Ablation and Hematopoietic Stem Cell Transplantation in Patients With Autoimmune-Related Retinopathy and Optic Neuropathy ARRON Syndrome Not Associated With Cancer
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
First subject over five years after the transplant The second subject is not in compliance with follow ups We do not plan to enroll more subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ARRON is a disease believed to be due to immune cells cells which normally protect the body but are now attacking the tissue in the retina andor optic nerve In addition the disease may affect the nerves in the ear or other parts of the body The affected nerves fail to respond or respond only weakly to stimuli causing numbing tingling pain and progressive muscle weakness If the nerves to the ear are affected reduced hearing or deafness may result The likelihood of progression of your disease is high This study is designed to examine whether treating patients with high dose cyclophosphamide and rabbit ATG drugs which reduce the function of the immune system followed by return of previously collected blood stem cells will stop the progression of ARRON syndrome Stem cells are undeveloped cells that have the capacity to grow into mature blood cells which normally circulate in the blood stream The purpose of the cyclophosphamide and rabbit ATG is to destroy the cells in the immune system which are thought to be causing this disease The purpose of the stem cell infusion is to restore the bodys blood production which will be severely impaired by the high dose chemotherapy and to produce a normal immune system that will no longer attack the body
Detailed Description:
None
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