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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPs | Experimental | 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. |
|
| Non-MPs | Active Comparator | Patients can receive platelet infusion but can not receive platelet stimulating factors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPs | Biological | MPs are generated from cord blood using a combination of cytokines. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet recovery after infusion of MPs | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of platelet infusion | 3 months | |
| incidence of acute toxicity | Acute toxicity mainly involves the heart,live and kidney. | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Lin, MD | Contact | +86-020-62787883 | lansinglinren@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu, MD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23390507 | Background | Xi J, Zhu H, Liu D, Nan X, Zheng W, Liu K, Shi W, Chen L, Lv Y, Yan F, Li Y, Xie X, Wang Y, Yue W, Xu X, Wei X, Zhu J, Huang X, Pei X. Infusion of megakaryocytic progenitor products generated from cord blood hematopoietic stem/progenitor cells: results of the phase 1 study. PLoS One. 2013;8(2):e54941. doi: 10.1371/journal.pone.0054941. Epub 2013 Feb 4. |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| D017370 | Interleukin-11 |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Guangzhou First People's Hospital |
| OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Southern Medical University, China | OTHER |
| Peking University People's Hospital | OTHER |
| Huazhong University of Science and Technology | OTHER |
| Sun Yat-sen University | OTHER |
| Academy Military Medical Science, China | INDUSTRY |
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| thrombopoietin (TPO) and interleukin-11 |
| Drug |
Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on. |
|
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D007378 | Interleukins |