Stem Cell Transplantation, Hematopoietic, Poor Graft Function, Delayed Platelet Engraftment, Hematological Diseases
Conditions
Keywords
Poor Graft Function, Delayed platelet engraftment, Peripheral Blood Stem Cell, Mesenchymal Stem Cells, Allogeneic hematopoietic stem cell transplantation
Brief summary
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.
Detailed description
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) is the only cure for many hematologic diseases. However, about 5-27% of patients would suffer from poor graft function (PGF) and more recipients might develop delayed platelet engraftment (DPE) after allo-HSCT. These complications are associated with considerable mortality related to infections or hemorrhagic complications. Treatment of PGF and DPE usually involves hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (TPO), or second transplantation, but these methods have dismal effect or even a significant risk of graft-versus-host disease (GVHD). Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs include improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. Some studies have shown that MSCs combined with PBSC or cord blood could be useful to improve engraftment after HSCT. Several reports suggested MSCs might be effective in the treatment of PGF. However, the efficacy of MSCs as single-drug treatment for PGF or DPE is unsatisfactory in our previous study. Therefore, in the present study, G-CSF mobilized PBSC will be used combined with MSCs in the patients with PGF or DPE after allo-HSCT.
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Hematopoietic Recovery | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of graft-versus-host disease | 1 year | Graft-versus-host disease (GVHD) includes acute GVHD and chronic GVHD. |
| Incidence of infections | 1 year | Infections include bacterial, invasive fungal and viral infections |
| Incidence of primary underlying disease relapse | 1 year | — |
| Incidence of acute toxicity | up to 100 days | Acute toxicity mainly involves the heart,live and kidney. |
Countries
China
Contacts
Primary ContactRen Lin, MD
Outcome results
None listed