Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease
Recruitment status was: Recruiting
|Acute Graft-versus-host Disease||Biological: Mesenchymal stem cells Biological: Non-mesenchymal stem cells||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Mesenchymal Stem Cells From Third-party Donors for Treatment of Refractory Acute Graft-versus-host Disease|
- The efficacy of treatment for refractory aGVHD [ Time Frame: 1 year ]The response criteria include complete response (CR), part response (PR), stable disease(SD) and progressive disease(PD). CR:aGVHD symptoms and signs disappear; PR:aGVHD symptoms and signs improve; SD:aGVHD symptoms and signs remain (without improvement or deterioration);PD: aGVHD symptoms and signs deteriorate.
- acute and late toxic side effects of MSCs treatment [ Time Frame: 1 year ]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.
- infections [ Time Frame: 1 year ]Infections will be mainly focused within the first 100 days after MSCs treatment.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Mesenchymal stem cells
Mesenchymal stem cell group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously)each week, four times for a cycle
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) each week, four times for a cycle.
Other Name: Mscs
Experimental: Non-mesenchymal stem cells
Non-mesenchymal stem cell group refers to treatment with other second line drugs
Biological: Non-mesenchymal stem cells
Other second line drugs are taken.
Other Name: Non-MSCs
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,acute graft-versus-host disease(aGVHD) remains an important complication that occurs in 35-80% patients. The mortality of aGVHD is positively correlated with its severity. At present, glucocorticoids is still the first line treatment of aGVHD. If glucocorticoids treatment is ineffective, second line drugs would be taken, such as tacrolimus(FK506), mycophenolate mofetil (MMF)and antithymocyte globulin (ATG). However, no method could be continuously effective. The effective rates of second line treatment to aGVHD is only about 60%. The effective rates and prognosis of refractory aGVHD are even worse.
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 GVHD after allo-HSCT and so on. However, the efficacy of treatment of refractory aGVHD 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 refractory aGVHD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765634
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Li Xuan +86-020-61641613 firstname.lastname@example.org|
|Principal Investigator: Qifa Liu|
|Principal Investigator:||Qifa Liu||Nanfang Hospital of Southern Medical University|