Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314483
Status:
UNKNOWN
Last Update Posted:
2007-07-06
First Post:
2006-04-12
Brief Title:
Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease
Sponsor:
Christian Medical College Vellore India
Organization:
Christian Medical College Vellore India
Study Overview
Official Title:
Evaluation of Potential Mesenchymal Stem Cells for the Treatment of Graft Versus Host Disease Following an Allogeneic Stem Cell Transplant
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
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:
Mesenchymal stem cells MSC have been shown to have immunosuppressive properties Following a bone marrowperipheral blood stem cell transplant a proportion of patients develop a condition called graft versus host disease GVHD In this condition the transplanted cells recognize the recipient as foreign and bring about an immune-mediated destruction of tissues The treatment for this condition is to use drugs that will cause immunosuppression A small subset of these patients develop a severe form of GVHD Grade III or IV which in spite of the best currently available treatment is associated with eventual death in more than 90 of cases The investigators propose to use infusions of expanded MSC from the donor to treat this condition A few reports on this approach have already been published in peer reviewed journals and preliminary results appear to be promising The investigators are also aware that larger trials have been initiated to study this After getting written informed consent the investigators will infuse expanded MSC into patients who develop steroid-resistant GVHD
Detailed Description:
A single center non randomized non blinded Phase III clinical trial is proposed to study the role of mesenchymal stem cells MSC in the management of steroid refractory graft versus host disease GVHD following an allogeneic stem cell transplant
Patients who develop grade II to IV GVHD following an allogeneic stem cell transplant will be enrolled MSC will be expanded from the donors of all patients who develop GVHD Expanded MSC will be infused at a dose of 1-2 million cellskg in patients who have steroid refractory GVHD
Response to therapy will be studied using established criteria for grading GVHD
Patients who develop grade II to IV GVHD following an allogeneic stem cell transplant will be enrolled MSC will be expanded from the donors of all patients who develop GVHD Expanded MSC will be infused at a dose of 1-2 million cellskg in patients who have steroid refractory GVHD
Response to therapy will be studied using established criteria for grading GVHD
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