Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284986
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2006-01-31
Brief Title:
Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Patients
Sponsor:
Mesoblast Inc
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Phase II Open Label Study to Evaluate the Safety and Efficacy of Prochymal Ex-vivo Cultured Adult Human Mesenchymal Stem Cells Infusion for the Salvage of Treatment-Refractory Acute GVHD Patients
Status:
COMPLETED
Status Verified Date:
2022-01
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:
This study is designed to evaluate the safety and efficacy of Prochymal Ex-vivo Cultured Adult Human Mesenchymal Stem Cells in participants experiencing treatment-refractory acute GVHD Grades III-IV that is refractory to standard first-line therapies and at least one second-line therapy
Detailed Description:
Allogeneic hematopoetic stem cell transplantation HCT is used in the treatment of a variety of hematological myeloproliferative and lymphoproliferative disorders and malignancies involving solid tumors Patients receiving HCT can develop a life-threatening condition called graft versus host disease GVHD GVHD occurs when donor T cells from the donor bone marrow recognize host cells as foreign and initiate an inflammatory immunological response The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD but some patients are refractory to current standard of care treatment For treatment-refractory patients with grades III-IV GVHD mortality is approximately 80 A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None