CMV Infection Clinical Trial
Official title:
Mesenchymal Stem Cells for Treatment of CMV Infection After Hematopoietic Stem Cell Transplant
The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Viral infections are common complications after allo-HSCT. With wide use of HLA-mismatch,
unrelated and cord blood donors as alternative sources of hematopoietic stem cells, and
anti-thymocyte globulin (ATG) as the standard prophylaxis of graft versus host disease
(GVHD) in HLA-mismatch and unrelated donor transplantation, allo-HSCT recipients are at
increasing risk for viral infections.
Till now, CMV remains one of the most important viruses and causes of death in the
recipients of allo-HSCT. Approximately 75% of CMV-seropositive recipients develop CMV
reactivation, and 20-30% of these patients develop CMV disease without intervention.
Ganciclovir is the first-line treatment of CMV diseases. However, bone marrow suppression,
which is the main and common side effect, limits the utility of ganciclovir in allo-HSCT
recipients. Besides, ganciclovir and other antiviral agents resistance has been reported up
to 28%. Since it has been known that specific immune response to CMV is important to control
reactivation, CMV-specific CTL has been used in prophylaxis and treatment of CMV viremia in
several studies. However, the production of CTL requires time. Mesenchymal stem cells (MSC)
are a form of multipotent adult stem cells that can be isolated from bone marrow (BM),
adipose tissue, and cord blood. In vivo experiment showed that MSCs have antimicrobial
activity.
In this trial, we will use MSCs in the recipients with refractory CMV infections.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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