Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency
|First Received Date ICMJE||December 8, 2011|
|Last Updated Date||March 24, 2015|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01489501 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency|
|Official Title ICMJE||Multicenter Study of Cultured Autologous Oral Mucosal Epithelial Cell-Sheet (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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Limbal Stem Cell Deficiency|
|Intervention ICMJE||Procedure: Surgical transplantation of CAOMECS to the ocular surface
Surgical transplantation of oral mucosa derived CAOMECS sheet onto eye cornea.
|Study Arm (s)||Experimental: only one arm available
Caomecs transplantation on eye cornea.
Intervention: Procedure: Surgical transplantation of CAOMECS to the ocular surface
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||2 Years to 74 Years (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Germany|
|Removed Location Countries|
|NCT Number ICMJE||NCT01489501|
|Other Study ID Numbers ICMJE||CS001-EU01, 2011-000598-30|
|Has Data Monitoring Committee||No|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||CellSeed France S.A.R.L.|
|Study Sponsor ICMJE||CellSeed France S.A.R.L.|
|Collaborators ICMJE||FGK Clinical Research GmbH|
|Information Provided By||CellSeed France S.A.R.L.|
|Verification Date||March 2015|
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