Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host Disease

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) for the treatment of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to first-line therapy.

The secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (MSC) on one-year survival rate, long-term survival rate, life quality and recurrence of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after HSCs transplantation and do not respond to hormone treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: 307 Hospital of PLA; Chinese PLA General Hospital; Peking Union Medical College; Zhejiang University
• Treatments: Cyclosporine; Cyclosporins; Glucocorticoids

Criteria

Inclusion Criteria:

• Extensive cGVHD with skin and/or liver damage developed after allogeneic hematopoietic stem cell transplantation

• cGVHD that do not response to conventional immunosuppressant treatment for two months

• KPS>= 30

• informed consent from the patient

Exclusion Criteria:

• Extensive cGVHD without skin or liver damage

• With other acute severe complications

• In pregnancy or lactation

• Disease relapses

• With non-hematological malignancy

• Have a history of mental disorder, drug or alcohol abuse over the past five years

• Allergic

• Participate in other clinical trial within three months before the start of this trial

• With bone marrow fibrosis

• Have undergone hematopoietic stem cell transplantation to treat solid tumor