Abstract
The efficacy and the safety of the administration of multipotent mesenchymal stromal cells (MMSCs) for acute graft-versus-host disease (aGVHD) prophylaxis following allogeneic hematopoietic cell transplantation (HSCT) were studied. This prospective clinical trial was based on the random patient allocation to the following two groups receiving (1) standard GVHD prophylaxis and (2) standard GVHD prophylaxis combined with MMSCs infusion. Bone marrow MMSCs from hematopoietic stem cell donors were cultured and administered to the recipients at doses of 0.9–1.3 × 106/kg when the blood counts indicated recovery. aGVHD of stage II–IV developed in 38.9% and 5.3% of patients in group 1 and group 2, respectively, (P = 0.002). There were no differences in the graft rejection rates, chronic GVHD development, or infectious complications. Overall mortality was 16.7% for patients in group 1 and 5.3% for patients in group 2. The efficacy and the safety of MMSC administration for aGVHD prophylaxis were demonstrated in this study.
Highlights
Severe graft-versus-host disease (GVHD) is a life-threatening complication following allogeneic hematopoietic stem cell transplantation [1, 2]
They were randomly allocated to the following two groups: (1) a group receiving the standard GVHD prophylaxis and (2) a group receiving the same prophylaxis combined with mesenchymal stromal cells (MMSCs) infusion
All of the human components used for MMSC cultivation were from hematopoietic stem cell donors
Summary
Severe graft-versus-host disease (GVHD) is a life-threatening complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT) [1, 2]. Steroids are the firstline treatment for established GVHD and have a response rate of 30–50%. The outcome for patients with severe, steroid-resistant acute GVHD is poor, and overall survival is low [3]. A large variety of drugs, such as corticosteroids, methotrexate, cyclosporine, and mycophenolate mofetil, are used for GVHD prophylaxis, but, approximately 20–80% of patients develop GVHD after alloHSCT [4, 5]. It is very important to develop new, effective methods for GVHD prevention. Multiple immune processes underlie the condition that is clinically expressed as GVHD after allo-HSCT [6]. The recipient’s antigen-presenting cells play an essential role in GVHD development. Host dendritic cells (DCs) have been identified as crucial for the priming of the CD4+ and CD8+
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