Türk Hematoloji Derneği

20.05.2008

Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study

Prof Katarina Le Blanc MD^a^,^,, Francesco Frassoni MD^b^,^‡, Lynne Ball MD^d^,^‡, Prof Franco Locatelli MD^f, Helene Roelofs PhD^e, Ian Lewis MD^g, Edoardo Lanino MD^c, Berit Sundberg BSc^a, Maria Ester Bernardo MD^f, Mats Remberger PhD^a, Giorgio Dini MD^c, Prof R Maarten Egeler MD^d, Andrea Bacigalupo MD^b, Prof Willem Fibbe MD^e, Prof Olle Ringdén MD^a and on behalf of the Developmental Committee of the European Group for Blood and Marrow Transplantation

Refers to:		Mesenchymal stem cells as cellular immunosuppressants The Lancet, Volume 371, Issue 9624, 10 May 2008-16 May 2008, Pages 1553-1554 Dominik Wolf, Anna Maria Wolf PDF (124 K)

Background

Severe graft-versus-host disease (GVHD) is a life-threatening complication after allogeneic transplantation with haemopoietic stem cells. Mesenchymal stem cells modulate immune responses in vitro and in vivo. We aimed to assess whether mesenchymal stem cells could ameliorate GVHD after haemopoietic-stem-cell transplantation.

Methods

Patients with steroid-resistant, severe, acute GVHD were treated with mesenchymal stem cells, derived with the European Group for Blood and Marrow Transplantation ex-vivo expansion procedure, in a multicentre, phase II experimental study. We recorded response, transplantation-related deaths, and other adverse events for up to 60 months' follow-up from infusion of the cells.

Findings

Between October, 2001, and January, 2007, 55 patients were treated. The median dose of bone-marrow derived mesenchymal stem cells was 1·4×10⁶ (min–max range 0·4–9×10⁶) cells per kg bodyweight. 27 patients received one dose, 22 received two doses, and six three to five doses of cells obtained from HLA-identical sibling donors (n=5), haploidentical donors (n=18), and third-party HLA-mismatched donors (n=69). 30 patients had a complete response and nine showed improvement. No patients had side-effects during or immediately after infusions of mesenchymal stem cells. Response rate was not related to donor HLA-match. Three patients had recurrent malignant disease and one developed de-novo acute myeloid leukaemia of recipient origin. Complete responders had lower transplantation-related mortality 1 year after infusion than did patients with partial or no response (11 [37%] of 30 vs 18 [72%] of 25; p=0·002) and higher overall survival 2 years after haemopoietic-stem-cell transplantation (16 [53%] of 30 vs four [16%] of 25; p=0·018).

Interpretation

Infusion of mesenchymal stem cells expanded in vitro, irrespective of the donor, might be an effective therapy for patients with steroid-resistant, acute GVHD.

OTURUM AÇ

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Steroide Dirençli Akut GVHH'de Mezenkimal Kök Hücre Tedavisi

Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study

Background

Methods

Findings

Interpretation

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