Mesenchymal Stem Cells Clinical Trial
Official title:
Mesenchymal Stem Cells From Third-party Donors for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation 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) can cure many hematologic
diseases. Although good progress has been made in the prevention and treatment of side
effects associated with transplantation, poor graft function (PGF) remains an important
complication that occurs in 5-27% of patients, and is associated with considerable morbidity
and 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 repeat transplantation, but these methods are
associated with short-term effect and a significant risk of graft-versus-host disease（GVHD）
development, respectively.
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 after allo-HSCT and so on. However, the
efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs
from a third-party donor is rarely reported. 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 in treating 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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