Status:
UNKNOWN
Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 e...
Detailed Description
Chronic graft-versus-host disease (GVHD) is one of the main limitations to successful allogeneic hematopoietic stem cell transplantation (HSCT), and has a substantial impact not only on survival but a...
Eligibility Criteria
Inclusion
- 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
- Invasive fungal disease.
- Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
- Patient is with a history of hypersensitivity to bovine products.
- Relapsed malignancy.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00972660
Start Date
September 1 2009
End Date
December 1 2017
Last Update
August 26 2014
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080