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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
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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 therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells (MSC) | Active Comparator | Patients with newly diagnosed cGvHD receive primary treatment plus MSC:
|
|
| Placebo | Placebo Comparator | Patients with newly diagnosed cGvHD receive primary treatment:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stromal Cells | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients responding to treatment of cGvHD with MSC | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 year | |
| Progression-free survival | 2 year | |
| Time without systemic immunosuppression |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 2 year | |
| Immune reconstitution including monitoring of absolute T-cell subsets, B-cells, NK-cells as well as biomarkers of cGvHD | 2 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du, Prof. | Contact | +86 02083827812-62122 | miyadu@hotmail.com | |
| Jianyu Weng, Prof. | Contact | +86 02083827812-62122 | wengjianyu1969@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Du, Prof. | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Du | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23070118 | Background | 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. | |
| 20818445 | Background | 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. |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| Third Affiliated Hospital, Sun Yat-Sen University |
| OTHER |
| Guangzhou First People's Hospital | OTHER |
| Academy Military Medical Science, China | INDUSTRY |
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|
| 2 year |
| Cumulative incidents of non-relapse mortality | 2 year |
| Adverse events | 2 year |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |