Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency
This clinical study is a scientific study on patients who do not have any limbal stem cells. In this clinical study tissue is taken from the inside of the mouth, and cells from that tissue (epithelial cells) will be grown to form a multilayered cell-sheet, called CAOMECS, which is then transplanted onto the cornea. This transplantation method should repair the damage of the cornea.
The aim of this study is to see if the transplantation of CAOMECS renews the surface of the eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood vessels forming.
|Limbal Stem Cell Deficiency||Procedure: Surgical transplantation of CAOMECS to the ocular surface||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Study of Cultured Autologous Oral Mucosal Epithelial Cell-Sheet (CAOMECS) Transplantation to Patients With Total Limbal Stem Cell Deficiency|
- Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis [ Time Frame: month 12 ]This is assessed by delayed fluorescein staining and impression cytology.
- Extent of neovascularization [ Time Frame: month 12 ]Measurement of the area of corneal neovascularisation as documented by photographs.
- Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis [ Time Frame: month 24 and 36 ]This is assessed by delayed fluorescein staining and impression cytology.
- Extent of neovascularization [ Time Frame: month 24 and 36 ]Measurement of the area of corneal neovascularisation as documented by photographs.
Experimental: only one arm available
Caomecs transplantation on eye cornea.
Procedure: Surgical transplantation of CAOMECS to the ocular surface
Surgical transplantation of oral mucosa derived CAOMECS sheet onto eye cornea.
This is an open clinical study without a control group, which means that all patients will be given the study treatment (CAOMECS).
Adults as well as minor patients can participate in this clinical trial.
CAOMECS is undergoing a clinical trial, which means that it has not yet been officially approved for the treatment of this disease. Up to now it was clinically tested in France, on 26 people with limbal stem cell loss.
The objective of this study is to restore the ocular surface epithelium of patients with total LSCD by preventing or reducing recurrent conjunctivalization and neovascularization up to 12 months post-transplantation.
This is a prospective, open, multi-center study with CAOMECS in patients with total LSCD. Stem cells will be isolated from an oral mucosa biopsy and will be grown in cell culture. The resultant epithelial cell-sheets will then be transplanted to the ocular surface of the respective patients under general anesthesia. After transplantation patients may be hospitalized according to routine clinical practice.
Overall, the study will consist of a screening visit where eligibility will be evaluated, the day of the biopsy, the day before the transplantation where baseline data will be evaluated, the transplantation (day 0), and a follow-up period consisting of nine visits at days 1, 5, and 10 and months 1, 3, 6, 12, 24, and 36. Other visits as clinically indicated may also occur.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489501
|Erlangen, Bavaria, Germany, 91054|
|Principal Investigator:||Friedrich Kruse, Prof. Dr.||Medizinische Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg|