Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fund for Scientific Research, Flanders, Belgium | OTHER |
| European Society of Cataract and Refractive Surgeons | OTHER |
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limbal Stem Cell Transplant | Experimental | The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultivated limbal stem cell graft transplantation | Procedure | A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Just before surgery and upto 1 years after surgery | |
| Conjunctivalization | Just before surgery and upto 1 years after surgery | |
| Vascularization | Just before surgery and upto 1 years after surgery | |
| Epithelialization | Just before surgery and upto 1 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged subsequent corneal graft survival time | 1 year post corneal transplant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nadia Zakaria, MBBS, PhD | University Hospital, Antwerp | Principal Investigator |
| Carina Koppen, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Marie J Tassignon, MD, PhD | University Hospital, Antwerp | Study Director |
| Zwi Berneman, MD,PhD | University Hospital, Antwerp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | Edegem | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19916804 | Background | Zakaria N, Koppen C, Van Tendeloo V, Berneman Z, Hopkinson A, Tassignon MJ. Standardized limbal epithelial stem cell graft generation and transplantation. Tissue Eng Part C Methods. 2010 Oct;16(5):921-7. doi: 10.1089/ten.TEC.2009.0634. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| D015783 | Aniridia |
| D013262 | Stevens-Johnson Syndrome |
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D005124 | Eye Abnormalities |
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D007499 |
| Iris Diseases |
| D014603 | Uveal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D003229 | Conjunctival Diseases |