MSC for Treatment of cGVHD After Allo-HSCT
- Conditions
- Chronic Graft-versus-host Disease
- Interventions
- Registration Number
- NCT04692376
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.
- Detailed Description
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,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.
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 cGVHD remains undetermined.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 152
- A patient age of 18-65 years
- Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Primary disease relapse
- Expected lifetime less than 3 months
- Patients with any conditions not suitable for the trial (investigators' decision)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSCs group Mesenchymal stem cells MSCs group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently. Control group Glucocorticoids Glucocorticoids and CsA will be used for treatment. MSCs group Glucocorticoids MSCs group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently. Control group cyclosporine Glucocorticoids and CsA will be used for treatment. MSCs group cyclosporine MSCs group refers to treatment with mesenchymal stem cells (1×10\^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
- Primary Outcome Measures
Name Time Method ORR 12 weeks after the first dose of MSCs Overall response rate （ORR）includes complete response (CR) and part response (PR).
- Secondary Outcome Measures
Name Time Method Response rate 4 weeks after the first dose of MSCs EBV DNA-emia 1 year after the first dose of MSCs EBV DNA-emia refers to detection of EBV DNA in peripheral blood via PCR.
OS 1 year after the first dose of MSCs Overall survival (OS)
DFS 1 year after the first dose of MSCs Disease-free survival (DFS)
CMV DNA-emia 1 year after the first dose of MSCs CMV DNA-emia refers to detection of CMV DNA in peripheral blood via PCR.
PGF 1 year after the first dose of MSCs Poor graft function (PGF) refers to a slow or incomplete recovery of blood cell counts (ANC ≤0.5x10\^9/L and PLT ≤20x10\^9/L) by +28 days after allo-HSCT or a fall in blood cell counts to levels fulfilling the diagnostic criteria for PGF after successful and prompt hematopoietic engraftment.
Trial Locations
- Locations (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China