Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency (LECT)

Ethisch Comité UZ Antwerpen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Limbal Stem Cell Deficiency

Treatments: Procedure: Cultivated limbal stem cell graft transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00845117

EC 7/28/153

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Limbal Stem Cell Transplant

Experimental group

Description:

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

Treatment:

Procedure: Cultivated limbal stem cell graft transplantation