A Phase 2 interventional study of Mesenchymal stem cells in Stem Cell Transplantation, Hematopoietic, Mesenchymal Stem Cells and Poor Graft Function, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-16.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation with ex-vivo-expanded BM-drived mesenchymal stem cells from third-party donors. Our first objective was to evaluate the effect of such treatment on poor graft function, and second object was to investigate the safety of such treatment.
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (PGF) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease（GVHD） development, respectively.
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 are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. However, the efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors in treating patients with PGF after allo-HSCT.
460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 274 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
Mesenchymal stem cells 1×10\^6 cells/kg, intravenously
Biological: Mesenchymal stem cells
Mesenchymal stem cells will be intravenously infused via a central venous catheter,at a dose of 1×10\^6 cells/kg, over 15 min. The vital signs of all patients will be closely monitored during and for 24h after MSCs administration. If the NEU and PLT levels do not attain the completely response(CR)standards within 14d, a second course of MSCs treatment will be given.
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.
Time frame: 1 year
infections, primary underlying disease relapse and any toxic side effects of MSCs treatment
Infections will be mainly focused within the first 100 days after MSCs treatment. Toxic side effects of treatment includes acute toxicity and late side effects. Acute toxicity principally involves the heart,live and kidney. Late toxic side effects involves principally the development of secondary tumors and relapse of the primary disease.
Time frame: 1 year
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University