Status:
UNKNOWN
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Conditions:
Chronic Graft-Versus-Host Disease
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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 :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02291770
Start Date
October 1 2014
End Date
December 1 2019
Last Update
November 14 2014
Active Locations (1)
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1
Xin Du
Guangzhou, Guangdong, China, 510080