Hematological Diseases Clinical Trial
Official title:
G-CSF Mobilized Peripheral Blood Stem Cell Combined With Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant
The purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation with Granulocyte Colony-Stimulating Factor (G-CSF) mobilized peripheral stem cell combined (PBSC) with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate the effect of such treatment on poor graft function, and second object was to investigate the safety of such treatment.
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) is the only cure for many
hematologic diseases. However, poor graft function (PGF) is an important complication after
allo-HSCT that occurs in 5-27% of patients, and is associated with considerable mortality
related to infections or hemorrhagic complications. Treatment of PGF usually involves the
prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor
(G-CSF), or second transplantation, but these methods are associated with dismal effect or
even a significant risk of graft-versus-host disease (GVHD).
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 include improving hematopoietic engraftment, preventing and treating
graft-versus-host disease after allo-HSCT and so on. Some studies have shown that MSCs
combined with PBSC or cord blood could be useful to improve engraftment after HSCT. Several
reports suggested MSCs might be effective in the treatment of PGF.
However, the efficacy of MSCs as single-drug treatment for PGF is unsatisfactory in our
previous study. Therefore, in the present study, G-CSF mobilized PBSC will be used combined
with MSCs in the patients with PGF after allo-HSCT.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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