Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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.

Study objective

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.

Methodology

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Limbal Stem Cell Deficiency

Clinical Trial Details

NCT number	NCT01489501
Study type	Interventional
Source	CellSeed France S.A.R.L.
Contact
Status	Withdrawn
Phase	Phase 3

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See also
Status	Clinical Trial	Phase
Completed	`NCT02568527` - Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients	N/A
Completed	`NCT00736307` - Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients	Phase 1/Phase 2
Available	`NCT02149732` - Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation	Phase 1/Phase 2
Terminated	`NCT02579993` - ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation	N/A
Recruiting	`NCT03943797` - Cultivated Autologous Oral Mucosal Epithelial Transplantation	Phase 1
Active, not recruiting	`NCT03549299` - Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD	Phase 1/Phase 2
Completed	`NCT03217435` - Corneal Epithelial Allograft From Living-related Donor for LSCD	N/A
Recruiting	`NCT03217487` - Corneal Epithelial Autograft for LSCD	N/A
Active, not recruiting	`NCT00845117` - Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency	Phase 1/Phase 2
Enrolling by invitation	`NCT03015779` - Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease	Phase 1/Phase 2
Active, not recruiting	`NCT02739113` - Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases	Phase 1/Phase 2
Not yet recruiting	`NCT06265298` - Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium	N/A
Recruiting	`NCT01756365` - Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency	N/A
Completed	`NCT02592330` - Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft	Phase 1/Phase 2
Recruiting	`NCT02318485` - Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms