Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure
Recruitment status was: Recruiting
|Hematopoietic Stem Cell Transplantation Mesenchymal Stem Cells Umbilical Cord Blood Graft Failure Hematological Diseases||Biological: Mesenchymal stem cells Biological: Mesenchymal stem cells and cord blood||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mesenchymal Stem Cells Combined With Cord Blood for Treatment of Graft Failure Following Autologous Hematopoietic Stem Cell Transplantation|
- hematopoietic recovery [ Time Frame: 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.
- infections, primary underlying disease relapse and any toxic side effects of MSCs treatment [ Time Frame: 1 year ]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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Mesenchymal stem cells
Mesenchymal stem cells group refers to treatment with 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) in day 1 and day 15 of the cycle. If the NEU and PLT levels do not attain the completely response(CR)standards after this cycle, mesenchymal stem cells combined with cord blood will be given. If the NEU and PLT levels attain the completely response(CR)or partly response(PR) standards after this cycle, another cycle with the same strategy will be given.
Experimental: Mesenchymal stem cells and cord blood
Mesenchymal stem cells and cord blood group refers to treatment with mesenchymal stem cells (at a dose of 1×10^6 cells/kg) and cord blood
Biological: Mesenchymal stem cells and cord blood
Mesenchymal stem cells will be given (at a dose of 1×10^6 cells/kg,intravenously infused via a central venous catheter)on day 1.day 15, day 29 and day 43 of the cycle. Cord blood will be given intravenously infused via a central venous catheter on day 2 of the cycle.
Autologous hematopoietic stem cell transplantation (auto-HSCT) are considered the standard of care for many malignancies, such as lymphoma, myeloma and some leukemias, and so on. Graft failure after auto-HSCT is a formidable complication. It occurs in 2-9.5% of patients and is associated with considerable morbidity and mortality related to infections and hemorrhagic complications. There are various options for the management of graft failure. The most common treatment of graft failure is growth factors such as granulocyte colony-stimulating factor (G-CSF)and recombinant erythropoietin,but it usually effective in the short term and no effect on platelet counts.
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 (GVHD) after allogeneic hematopoietic stem cell transplantation and so on.As an important source of hematopoietic stem cell, cord blood has been widely used in clinical practice. It is reported that cord blood combined with MSCs can increase engraftment after allogeneic hematopoietic stem cell transplantation. However, to our knowledge, the report about efficacy of treatment of graft that develops after auto-HSCT using expanded BM-derived MSCs from a third-party donor combined with cord blood is absent.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 or MSCs combined with cord blood in treating patients with graft failure after auto-HSCT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763099
|Contact: Ren Lin, MDfirstname.lastname@example.org|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Ren Lin, MD +86-020-61641613 email@example.com|
|Principal Investigator:||Qifa Liu, MD||Nanfang Hospital of Southern Medical University|