Early Treatment of Acute Graft Versus Host Disease With Bone Marrow-Derived Mesenchymal Stem Cells and Corticosteroids

Summary

Background: \- Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow from healthy volunteers. Objectives: \- To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s immune system responds to BMSC. Eligibility: \- People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD. People who have had certain previous immunosuppressive therapy may be ineligible. Design: * Participants will be screened with medical history, physical exam, and blood tests. They will have a GVHD exam, including skin and stool tests. They must have a functioning central line. * Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the rest of the weeks. * Up to 12 cell infusions: * Participants will come to the clinic twice weekly. * They will get medicine to prevent side effects (like Tylenol and Benadryl). * BMSC will be given through a small plastic tube in an arm vein or through an IV catheter. It will last 20 60 minutes. * Participants will be monitored for 1 hour. * Follow-up visits: Up to twice a week, participants will have physical exam and blood tests. They may have a GVHD exam. * Participants who have a tissue biopsy outside the study will be asked to send a sample to the study.

Timeline

Start

2015-02-23

Primary completion

2017-12-13

Completion

2017-12-13

Publications

• Background Holtan SG, Pasquini M, Weisdorf DJ. Acute graft-versus-host disease: a bench-to-bedside update. Blood. 2014 Jul 17;124(3):363-73. doi: 10.1182/blood-2014-01-514786. Epub 2014 Jun 9.
• Background Kersting S, Koomans HA, Hene RJ, Verdonck LF. Acute renal failure after allogeneic myeloablative stem cell transplantation: retrospective analysis of incidence, risk factors and survival. Bone Marrow Transplant. 2007 Mar;39(6):359-65. doi: 10.1038/sj.bmt.1705599.
• Background Martin PJ, Rizzo JD, Wingard JR, Ballen K, Curtin PT, Cutler C, Litzow MR, Nieto Y, Savani BN, Schriber JR, Shaughnessy PJ, Wall DA, Carpenter PA. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012 Aug;18(8):1150-63. doi: 10.1016/j.bbmt.2012.04.005. Epub 2012 Apr 14.

Drugs

Indications