Evaluation of the Role of Mesenchymal Stem Cells in the Treatment of Graft Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT00314483|
Recruitment Status : Unknown
Verified July 2007 by Christian Medical College, Vellore, India.
Recruitment status was: Recruiting
First Posted : April 14, 2006
Last Update Posted : July 6, 2007
|Condition or disease||Intervention/treatment||Phase|
|Graft vs Host Disease||Drug: Mesenchymal Stem Cell Infusion||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Potential Mesenchymal Stem Cells for the Treatment of Graft Versus Host Disease Following an Allogeneic Stem Cell Transplant|
|Study Start Date :||June 2007|
|Estimated Study Completion Date :||June 2008|
- Control of GVHD [ Time Frame: 8 weeks ]
- Infusional toxicity [ Time Frame: 48 hours ]
- Risk of relapse [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314483
|Contact: Vikram Mathews, MDfirstname.lastname@example.org|
|Contact: Alok Srivastava, MD, FRACPemail@example.com|
|Department of Haematology, Christian Medical College||Recruiting|
|Vellore, Tamil Nadu, India, 632002|
|Contact: Vikram Mathews, MD 91-416-2282891 firstname.lastname@example.org|
|Contact: Alok Srivastava, MD, FRACP 91-416-2282472 email@example.com|
|Principal Investigator: Vikram Mathews, MD|
|Principal Investigator:||Vikram Mathews, MD||Christian Medical College, Vellore, India|