Thrombocytopenia Clinical Trial
Official title:
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy
The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by chemotherapy in patients with acute leukemia (AL).
Thrombocytopenia is a common and potentially fatal complication of chemotherapy and
hematopoietic stem cell transplantation. Owing to the short storage time and increased
demand of platelets from unrelated donors, a constant shortage in the supply of platelets
has become an important medical and society challenge. Therefore, investigation of
alternative sources of platelets would be beneficial.
Hematopoietic stem cells (HSCs) can be used to generate functional megakaryocytic
progenitors (MPs), megakaryocytes, and platelets on a large scale. Functional MPs and
platelets have successfully been produced in vitro from CD34+ hematopoietic cells from bone
marrow, cord blood, and peripheral blood. Several studies have reported that transplantation
of in vitro auto-producing MPs can promote platelet recovery after high-dose therapy and HSC
transplantation.
Umbilical cord blood is an abundant source of HSCs. In vitro large scale production of MPs
from cord blood could represent an effective platelet substitute. Theoretically, the
additional transplantation of ex vivo generated progenitor and post-progenitor cells might
lead to the production of sufficient numbers of mature functional cells within a few days
after transplantation.
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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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