Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Design: Treatment, Randomized, Open Label, Parallel Assignment,Safety/Efficacy Study.

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) expanded ex-vivo infusion for the treatment of patients who have developed a newly diagnosed extensive or refractory chronic graft versus host disease (chronic GVHD) to the usual therapeutic measures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong General Hospital; Guangdong Provincial People's Hospital
• Collaborator: Sun Yat-sen University
• Treatments: Cyclosporine; Cyclosporins; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Informed consent obtained from patient and donor.

• Any patient who has undergone allogeneic stem cell transplantation with extensive chronic 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.