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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02241031
Other study ID # MPs-AL-2014
Secondary ID
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


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
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