Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
NCT ID: NCT02291770
Last Updated: 2014-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
130 participants
INTERVENTIONAL
2014-10-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mesenchymal stem cells (MSC)
Patients with newly diagnosed cGvHD receive primary treatment plus MSC:
1. MSC+prednisone+cyclosporine;
2. MSC+prednisone+tacrolimus;
3. MSC+prednisone+mycophenolate mofetil.
Mesenchymal Stromal Cells
Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
Placebo
Patients with newly diagnosed cGvHD receive primary treatment:
1. Placebo+prednisone+cyclosporine;
2. Placebo+prednisone+tacrolimus;
3. Placebo+prednisone+mycophenolate mofetil.
No interventions assigned to this group
Interventions
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Mesenchymal Stromal Cells
Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
* Patient is with a history of hypersensitivity to bovine products.
* Relapsed malignancy.
14 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangzhou First People's Hospital
OTHER
Academy Military Medical Science, China
INDUSTRY
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Xin Du, Prof.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Locations
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Xin Du
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Weng J, He C, Lai P, Luo C, Guo R, Wu S, Geng S, Xiangpeng A, Liu X, Du X. Mesenchymal stromal cells treatment attenuates dry eye in patients with chronic graft-versus-host disease. Mol Ther. 2012 Dec;20(12):2347-54. doi: 10.1038/mt.2012.208. Epub 2012 Oct 16.
Weng JY, Du X, Geng SX, Peng YW, Wang Z, Lu ZS, Wu SJ, Luo CW, Guo R, Ling W, Deng CX, Liao PJ, Xiang AP. Mesenchymal stem cell as salvage treatment for refractory chronic GVHD. Bone Marrow Transplant. 2010 Dec;45(12):1732-40. doi: 10.1038/bmt.2010.195. Epub 2010 Sep 6.
Other Identifiers
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No.GRDEC 2014210H
Identifier Type: -
Identifier Source: org_study_id