Acute Graft-versus-host Disease Clinical Trial
Official title:
Mesenchymal Stem Cells From Third-party Donors for Treatment of Refractory Acute Graft-versus-host Disease
The purpose of this study is to evaluate the utility of treating patients experiencing refractory acute graft-versus-host disease with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. The objective was to evaluate the effect and safety of such treatment on refractory acute graft-versus-host disease.
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic
diseases. Although great progress has been made in the prevention and treatment of side
effects associated with transplantation,acute graft-versus-host disease(aGVHD) remains an
important complication that occurs in 35-80% patients. The mortality of aGVHD is positively
correlated with its severity. At present, glucocorticoids is still the first line treatment
of aGVHD. If glucocorticoids treatment is ineffective, second line drugs would be taken,
such as tacrolimus(FK506), mycophenolate mofetil (MMF)and antithymocyte globulin (ATG).
However, no method could be continuously effective. The effective rates of second line
treatment to aGVHD is only about 60%. The effective rates and prognosis of refractory aGVHD
are even worse.
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 GVHD after allo-HSCT and so on. However, the efficacy of treatment
of refractory aGVHD 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
refractory aGVHD.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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