Hematological Diseases Clinical Trial
Official title:
Mesenchymal Stem Cells With or Without G-CSF Mobilized Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplant
The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC) in treating patients experiencing poor graft function or delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age:14-65 years - PGF or DPE after allo-HSCT - Subjects (or their legally acceptable representatives) must have signed an informed consent document Exclusion Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
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 |
China,
Meuleman N, Tondreau T, Ahmad I, Kwan J, Crokaert F, Delforge A, Dorval C, Martiat P, Lewalle P, Lagneaux L, Bron D. Infusion of mesenchymal stromal cells can aid hematopoietic recovery following allogeneic hematopoietic stem cell myeloablative transplant: a pilot study. Stem Cells Dev. 2009 Nov;18(9):1247-52. doi: 10.1089/scd.2009.0029. — View Citation
Sánchez-Guijo FM, López-Villar O, López-Anglada L, Villarón EM, Muntión S, Díez-Campelo M, Perez-Simón JA, San Miguel JF, Caballero D, del Cañizo MC. Allogeneic mesenchymal stem cell therapy for refractory cytopenias after hematopoietic stem cell transplantation. Transfusion. 2012 May;52(5):1086-91. doi: 10.1111/j.1537-2995.2011.03400.x. Epub 2011 Oct 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Hematopoietic Recovery | Hematopoietic reconstitution post-transplantation is defined as reconstitution of both neutrophil and platelet numbers. Neutrophil reconstitution is defined as occurring on the first 3 consecutive days with an neutrophil(NEU)>0.5×10^9/L, and platelet (PLT) reconstitution is defined as the first >20×10^9/L for 3 consecutive days. | 1 year | No |
Secondary | Incidence of graft-versus-host disease | Graft-versus-host disease (GVHD) includes acute GVHD and chronic GVHD. | 1 year | No |
Secondary | Incidence of infections | Infections include bacterial, invasive fungal and viral infections | 1 year | No |
Secondary | Incidence of primary underlying disease relapse | 1 year | No | |
Secondary | Incidence of acute toxicity | Acute toxicity mainly involves the heart,live and kidney. | up to 100 days | Yes |
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