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Volume 15, Issue 7, Pages 804-811 (July 2009)


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Adult Human Mesenchymal Stem Cells Added to Corticosteroid Therapy for the Treatment of Acute Graft-versus-Host Disease

Partow Kebriaei1Corresponding Author Informationemail address, Luis Isola2, Erkut Bahceci3, Kent Holland4, Scott Rowley5, Joseph McGuirk6, Marcel Devetten7, Jan Jansen8, Roger Herzig9, Michael Schuster10, Rod Monroy11, Joseph Uberti12

Received 28 January 2009; accepted 12 March 2009.

The unique immunomodulatory properties of mesenchymal stem cells (MSCs) make them a rationale agent to investigate for graft-versus-host disease (GVHD). Human MSCs were used to treat de novo acute GVHD (aGVHD). Patients with grades II-IV GVHD were randomized to receive 2 treatments of human MSCs (Prochymal®) at a dose of either 2 or 8 million MSCs/kg in combination with corticosteroids. Patients received GVHD prophylaxis with tacrolimus, cyclosporine, (CsA) or mycophenolate mofetil (MMF). Study endpoints included safety of Prochymal administration, induction of response to Prochymal, and overall response of aGVHD by day 28, and long-term safety. Thirty-two patients were enrolled, with 31 evaluable: 21 males, 10 females; median age 52 years (range: 34-67). Twenty-one patients had grade II, 8 had grade III, and 3 had grade IV aGVHD. Ninety-four percent of patients had an initial response to Prochymal (77% complete response [CR] and 16% partial response [PR]). No infusional toxicities or ectopic tissue formations were reported. There was no difference with respect to safety or efficacy between the low and high Prochymal dose. In conclusion, Prochymal can be infused safely into patients with aGVHD and induces response in a high proportion of GVHD patients.

1 Department of Stem Cell Transplantation and Cellular Therapy, M.D. Anderson Cancer Center, Houston, Texas

2 Mount Sinai Hospital, New York, New York

3 Bristol-Myers Squibb, New York, New York

4 Blood and Marrow Transplant Group, Northside Hospital, Atlanta, Georgia

5 Bone Marrow Transplant Program, Hackensack University, Hackensack, New Jersey

6 Blood and Marrow Transplantation, Kansas City Cancer Center, Kansas City, Missouri

7 Hematology/Oncology, Lied Transplantation Center, University of Nebraska Medical Center, Omaha, Nebraska

8 Indiana Bone Marrow Transplantation, St. Francis Hospital and Health Center, Indianapolis, Indiana

9 Blood and Marrow Transplantation Program, James Graham Brown Cancer Center, Louisville, Kentucky

10 New York Hospital, Cornell Medical Center, New York, New York

11 Osiris Therapeutics, Inc., Columbia, Maryland

12 Blood and Marrow Stem Cell Transplantation Program, Karmanos Cancer Institute, Detroit, Michian

Corresponding Author InformationCorrespondence and reprint requests: Partow Kebriaei, MD, Department of Stem Cell Transplantation and Cellular Therapy, Univesity of Texas M.D. Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 423, Houston, Texas 77030.

 Financial disclosure: See Acknowledgments on page 810.

PII: S1083-8791(09)00153-0

doi:10.1016/j.bbmt.2008.03.012


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