Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02241031|
Recruitment Status : Unknown
Verified September 2014 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : September 16, 2014
Last Update Posted : September 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hematological Diseases Thrombocytopenia||Biological: MPs Drug: thrombopoietin (TPO) and interleukin-11||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
MPs will be intravenously infused within 48 hours after chemotherapy. During the study period, patients can receive platelet infusion but can not receive platelet stimulating factors.
MPs are generated from cord blood using a combination of cytokines.
Active Comparator: Non-MPs
Patients can receive platelet infusion but can not receive platelet stimulating factors.
Drug: thrombopoietin (TPO) and interleukin-11
Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.
- Platelet recovery after infusion of MPs [ Time Frame: 3 months ]Platelet recovery after infusion of MPs includes the time from infusion to platelet count≥20×10^9/L,50×10^9/L,100×10^9/L.
- frequency of platelet infusion [ Time Frame: 3 months ]
- incidence of acute toxicity [ Time Frame: 3 month ]Acute toxicity mainly involves the heart,live and kidney.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241031
|Contact: Ren Lin, MDemail@example.com|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Ren Lin, MD +86-020-62787883 firstname.lastname@example.org|
|Principal Investigator: Qifa Liu, MD|
|Principal Investigator:||Qifa Liu, MD||Nanfang Hospital of Southern Medical University|