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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00234-35 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Animal Compound Free Medium | Experimental | Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium |
|
| organ culture medium containing 2% of fœtal calf serum | Active Comparator | Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corneal graft | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| the primary outcome is the endothelial cell density (ECD) of the corneal grafts. | one year after graft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Thuret, MD-PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | 25000 | France | |||
| CHU Clermont-Ferrand |
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| ID | Term |
|---|---|
| D016039 | Corneal Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Clermont-Ferrand |
| 63003 |
| France |
| CHU Grenoble | Grenoble | 38043 | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| D054140 |
| Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |