Regenerating the cornea through transplantation of limbal stem cells

Conditions: Primary and secondary Limbal Stem Cell Deficiencies
MedDRA version: 17.1Level: PTClassification code 10069798Term: Amniotic membrane graftSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 17.1Level: PTClassification code 10072138Term: Limbal stem cell deficiencySystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-004247-24-BE

Lead Sponsor: Antwerp University Hospital (UZA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Voluntary written informed consent
2. 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.
3. 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.
4. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation. Negative serum or urine ß-HCG pregnancy test at screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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