Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia

Thrombocytopenia Clinical Trial

Official title:

Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia in Patients With Acute Leukemia Receiving Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02241031
• Other study ID #: MPs-AL-2014
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 13, 2014
• Last updated: September 15, 2014
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ren Lin, MD
• Phone: +86-020-62787883
• Email: lansinglinren[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Diseases
• Thrombocytopenia
• Thrombocytosis

Intervention

Biological:
• MPs
MPs are generated from cord blood using a combination of cytokines.

Drug:
• thrombopoietin (TPO) and interleukin-11
Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (11)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

Academy Military Medical Science, China, Guangdong General Hospital, Guangzhou First Municipal People’s Hospital, Guangzhou General Hospital of Guangzhou Military Command, Huazhong University of Science and Technology, Peking University People's Hospital, Southern Medical University, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	frequency of platelet infusion		3 months	No
Secondary	incidence of acute toxicity	Acute toxicity mainly involves the heart,live and kidney.	3 month	No