Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease
Recruitment status was: Recruiting
Graft vs Host Disease
Drug: Mesenchymal Stem Cell Infusion
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Potential Mesenchymal Stem Cells for the Treatment of Graft Versus Host Disease Following an Allogeneic Stem Cell Transplant|
- Control of GVHD [ Time Frame: 8 weeks ]
- Infusional toxicity [ Time Frame: 48 hours ]
- Risk of relapse [ Time Frame: One year ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2008|
A single center non randomized, non blinded Phase I/II 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 cells/kg in patients who have steroid refractory GVHD.
Response to therapy will be studied using established criteria for grading GVHD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314483
|Department of Haematology, Christian Medical College|
|Vellore, Tamil Nadu, India, 632002|
|Principal Investigator:||Vikram Mathews, MD||Christian Medical College, Vellore, India|