Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01895244
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2013-07-01
Brief Title:
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Highdose Chemotherapy and Transplantation of 34 Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation
Status:
COMPLETED
Status Verified Date:
2024-07
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:
AST-MOMA
Brief Summary:
Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful transplantation
Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial
To reduce treatment toxicity we reduce the dose of Cyclophosphamide CYC for mobilisation to 2x1g
Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC as CYC has known cardiotoxic side effects
Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial
To reduce treatment toxicity we reduce the dose of Cyclophosphamide CYC for mobilisation to 2x1g
Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC as CYC has known cardiotoxic side effects
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