Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure Following Autologous Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the utility of treating patients experiencing graft failure after autologous hematopoietic stem cell transplantation with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors or mesenchymal stem cells combined with cord blood. The first objective of this study was to evaluate the effect of such treatment on graft failure, and second object was to investigate the safety of such treatment.
Autologous hematopoietic stem cell transplantation (auto-HSCT) are considered the standard
of care for many malignancies, such as lymphoma, myeloma and some leukemias, and so on.
Graft failure after auto-HSCT is a formidable complication. It occurs in 2-9.5% of patients
and is associated with considerable morbidity and mortality related to infections and
hemorrhagic complications. There are various options for the management of graft failure.
The most common treatment of graft failure is growth factors such as granulocyte
colony-stimulating factor (G-CSF)and recombinant erythropoietin,but it usually effective in
the short term and no effect on platelet counts.
Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be
isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of
human MSCs are evolving rapidly with goals of improving hematopoietic engraftment,
preventing and treating graft-versus-host disease (GVHD) after allogeneic hematopoietic stem
cell transplantation and so on.As an important source of hematopoietic stem cell, cord blood
has been widely used in clinical practice. It is reported that cord blood combined with MSCs
can increase engraftment after allogeneic hematopoietic stem cell transplantation. However,
to our knowledge, the report about efficacy of treatment of graft that develops after
auto-HSCT using expanded BM-derived MSCs from a third-party donor combined with cord blood
is absent.If such treatment could be shown to be effective and safe, BM-derived MSCs could
potentially be used as an universal donor material. This would have a major impact because
the generation of donor-specific MSCs is time-consuming, costly, and often impractical if
the clinical status of a patient is urgent.
In the present study, the investigators will prospectively evaluate the efficacy and safety
of ex-vivo-expanded BM-derived MSCs from third-party donors or MSCs combined with cord blood
in treating patients with graft failure after auto-HSCT.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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