Acute GVH Disease Clinical Trial
Official title:
Open-Label, Single-Center, Self Control, Phase Ⅰ/Ⅱ Clinical Trial to Evaluate the Safety and the Efficacy of Umbilical Cord-derived Mesenchymal Stem Cells in Patients With Acute Graft-versus-host Disease
Allogenic haemopoietic stem cell transplantation (allo-HSCT) is the treatment for many malignant and non-malignant hematologic disorders. Acute graft-versus-host disease (aGVHD) is a serious life-threatening complication after allo-HSCT. The outcome for patients with aGVHD is poor and overall survival is low. Acute graft-versus-host disease (GVHD), as the major complication of allogeneic peripheral blood stem cell transplantation(PBSCT), limits the application of this curative therapy. Mesenchymal stem cells (MSCs) are multipotent stem cells, which are able to modulate immune response in vitro and in vivo, and have possibilities of treating diseases caused by immune dysregulation such as aGVHD. MSCs obtained from umbilical cord (UC) have similar immunosuppressive properties as bone marrow-MSCs. In addition, UC-derived MSCs can be used for off-the-shelf use and are obtained without any harm to donors than bone marrow-MSCs. Therefore, the investigators designed this study to evaluate the safety and efficacy of UC-derived MSCs in patients with aGVHD.
The mesenchymal stem cells (MSC) is a class of low immunogenicity from mesoderm, had the
self-renewal and differentiation potential as pluripotent stem cells. The umbilical cord is
one of the important sources of MSC. Human UC-MSC compared with the bone marrow-derived MSC
has the following advantages: (1) the umbilical cord, as a "waste" after giving birth can be
obtained without any harm to the donor. (2) easy available, and no ethical issues. (3) its
likelihood of contamination is small because of the protection of the placental barrier. (4)
human UC-MSC has a stronger amplification capacity, a shorter doubling time, a higher colony
forming efficiency and lower immunogenicity. (5) which avoids the activity and
differentiation of bone marrow-derived MSC latent with the donor disadvantage of increasing
age decreased.
human UC-MSC not only for hematopoietic stem cell graft implantation and amplification has a
role in promoting and exhibit immunomodulatory effects and characteristics of damaged or
targeted sites of chronic inflammation. human UC-MSC in the prevention and treatment of
graft-versus-host disease (GVHD) induced organ transplantation immune tolerance and other
fields has broad application prospects.
After more than 10 years of exploration, the investigators and other practitioners caught
studies found that the umbilical cord is more suitable as mesenchymal stem cells seed cells
relative to the bone marrow, umbilical cord easily obtained, no ethical issues, better
amplification ability in vitro, viral contamination risk is small, and many other
advantages. Therefore, over the years, the investigator team for the umbilical cord
mesenchymal stem cells in a lot of the basic work has been confirmed that mesenchymal stem
cells derived from the umbilical cord had safety and effectiveness in in the treatment of
acute graft versus host disease in zoology test, and successfully establish a perfect
umbilical cord mesenchymal stem cells in standard operating procedures (including screening
umbilical cord, large-scale preparation, quality inspection, preservation, recovery,
transportation, infusion, etc.). The investigators will carry out the clinical research
based on above preliminary results.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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