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| Name | Class |
|---|---|
| Iniciativa Andaluza en Terapias Avanzadas | OTHER |
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The main purpose of this trial is to assess the safety and feasibility of treatment with two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed chronic and extensive graft versus host disease (GVHD).
Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell division and maintaining these cells in a quiescent state. This supports the hypothesis that MSCs are universal suppressors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment plus high dose: 3x10e6 cells / Kg. | Experimental | Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
|
| Conventional treatment plus low dose: 1x10e6 cells / Kg | Experimental | Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. | Other | Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients in each group that may potentially reduce corticosteroids at week 7, 20 and 42, started immunosuppressive treatment and percentage of patients at week 56 have been suspended on full immunosuppressive treatment | 12 months | |
| Overall survival and disease-free survival. |
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Inclusion Criteria:
Patients who develop chronic extensive GVHD as determined by the National Institute of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD (Biol Blood Marrow Transplant 2005; 11: 945-955), and which meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Jurado Chacón, MD | Haematology Department, Hospital Universitario Virgen de las Nieves de Granada. Spain. | Study Chair |
| Ildefonso Espigado, MD | Haematology Department, Hospital Universitario Virgen del Rocío de Sevilla, Spain. | Principal Investigator |
| Carlos Solano Vercet, MD | Haematology and Oncology Department. Hospital Clínico Universitario de Valencia, Spain. | Principal Investigator |
| Sebastián Garzón López., MD | Hospital de Jerez de la Frontera, Cádiz. Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Jerez de la Frontera. | Jerez de la Frontera | Cádiz. | 11407 | Spain | ||
| Hospital Universitario Virgen de las Nieves |
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| Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. | Other | Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg. Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin. |
|
| 12 months |
| Changes in lymphocyte subsets and levels of inflammatory and antiinflammatory cytokines in each of the groups. | 12 months |
| Granada |
| Granada. |
| 18014. |
| Spain |
| Hospital Universitario Virgen del Rocío de Sevilla | Seville | Sevilla | 41013 | Spain |
| Hospital Clínico de Valencia | Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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