Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136903
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2005-08-25
Brief Title:
Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease GVHD
Sponsor:
Mesoblast Inc
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Phase II Randomized Study to Evaluate the Safety and Efficacy of Prochymal Ex-vivo Cultured Adult Human Mesenchymal Stem Cells For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation
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:
To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human mesenchymal stem cells hMSCs Prochymal in participants experiencing acute GVHD Grades II-IV post hematopoietic stem cells HSC transplant
Detailed Description:
Protocol 260 - Participants will be randomized with equal probability to the treatment arms 2 million cellskilogram kg of Prochymal or 8 million cellskg of Prochymal using a stratified block design The stratification factor is acute GVHD grade For the purpose of stratification the GVHD grades are II and III-IV Treatment with investigational agent will be administered on study Days 1 and 4 Participants will be followed for safety and efficacy until Day 28 after initiation of treatment with the investigational agent or until withdrawal or death whichever occurs first
Protocol 261- This study is designed as a long-term safety follow-up of participants who take part in the preceding clinical study of Prochymal Protocol 260 for the treatment of acute GVHD Participants will be enrolled in Study 261 upon completion of the preceding Study 260
Protocol 261- This study is designed as a long-term safety follow-up of participants who take part in the preceding clinical study of Prochymal Protocol 260 for the treatment of acute GVHD Participants will be enrolled in Study 261 upon completion of the preceding Study 260
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