Hematological Diseases, Thrombocytopenia
Conditions
Keywords
Megakaryocytic Progenitor Products, Hematological Diseases, Thrombocytopenia
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALMPs
MPs are generated from cord blood using a combination of cytokines.
DRUGthrombopoietin (TPO) and interleukin-11
Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.
Sponsors
Guangdong Provincial People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Peking University People's Hospital
Huazhong University of Science and Technology
Sun Yat-sen University
Academy Military Medical Science, China
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age：14-65 years * achieve complete remission of acute leukemia * the first course of consolidation chemotherapy * ECOG grades 0 or 1 * expected survival time ≥ three months * Subjects (or their legally acceptable representatives) must have signed an informed consent document.
Exclusion criteria
* cardiac dysfunction (particularly congestive heart failure), hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal), renal dysfunction (creatinine clearance rate \< 30 mL/min) * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet recovery after infusion of MPs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of platelet infusion | 3 months | — |
| incidence of acute toxicity | 3 month | Acute toxicity mainly involves the heart,live and kidney. |
Countries
China
Contacts
Primary ContactRen Lin, MD
Outcome results
None listed