Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
Phase 3
- Conditions
- Chronic Graft-Versus-Host Disease
- Interventions
- Biological: Mesenchymal Stromal Cells
- Registration Number
- NCT02291770
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Newly diagnosed cGvHD
- Informed consent obtained from patient and donor.
- Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
- Have not received additional agent for cGVHD within 3 months.
- Expected life is more than 90 days.
- Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
Exclusion Criteria
- Invasive fungal disease.
- Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
- Patient is with a history of hypersensitivity to bovine products.
- Relapsed malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesenchymal stem cells (MSC) Mesenchymal Stromal Cells Patients with newly diagnosed cGvHD receive primary treatment plus MSC: 1. MSC+prednisone+cyclosporine; 2. MSC+prednisone+tacrolimus; 3. MSC+prednisone+mycophenolate mofetil.
- Primary Outcome Measures
Name Time Method Proportion of patients responding to treatment of cGvHD with MSC 90 days
- Secondary Outcome Measures
Name Time Method Overall survival 2 year Adverse events 2 year Progression-free survival 2 year Cumulative incidents of non-relapse mortality 2 year Time without systemic immunosuppression 2 year
Trial Locations
- Locations (1)
Xin Du
🇨🇳Guangzhou, Guangdong, China