Acute Graft-versus-host Disease Clinical Trial
Official title:
Mesenchymal Stem Cells Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for
several hematological disorders. Although good progress has been made in the prevention and
treatment of side effects associated with transplantation, aGVHDremains a common and
life-threatening complication with poor prognosis. Corticosteroids are still acted as the
first-line treatments of aGVHD, with a response rate of 50-80. However, those who failed to
initial therapy only have 10-30% long-term survival.
Mesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be
isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord.
Such cells possess the capacity to suppress immunological responses, support hematopoiesis
and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing
and treating GVHD. Although the results are still controversy, most prospective and
retrospective data suggest that MSCs are effective to aGVHD.
In the present study, the investigators will prospectively evaluate the efficacy and safety
of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal
antibody and calcineurin inhibitors in treating patients with aGVHD.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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