LECT: Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Sponsor

Ethisch Comité UZ Antwerpen (Other)

Overall Status

Unknown status

CT.gov ID

NCT00845117

Collaborator

Fund for Scientific Research, Flanders, Belgium (Other), European Society of Cataract and Refractive Surgeons (Other), Agentschap voor Innovatie door Wetenschap en Technologie (Other)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Limbal Stem Cell Deficiency	Procedure: Cultivated limbal stem cell graft transplantation	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Limbal Stem Cell Transplant The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.	Procedure: Cultivated limbal stem cell graft transplantation 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.

Arm

Intervention/Treatment

Experimental: Limbal Stem Cell Transplant

The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.

Procedure: Cultivated limbal stem cell graft transplantation

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Prolonged subsequent corneal graft survival time [1 year post corneal transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

Subjects who are pregnant or lactating
Subjects who have sensitivity to drugs that provide local anesthesia
Subjects suffering from active infection of the external eye
Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)