Status:
UNKNOWN
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Chronic Graft Versus Host Disease
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Zhejiang University
Chinese PLA General Hospital
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
2-60 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Chronic Graft-versus-host disease (GVHD)， with the incidence of 30%-60%, is a serious late complication of allogeneic hematopoietic stem cell transplantation (HSCT) and is the major cause of death in ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01526850
Start Date
February 1 2012
End Date
June 1 2014
Last Update
August 3 2012
Active Locations (1)
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1
Zhejiang University
Hangzhou, Zhejiang, China