To evaluate the activity of CAOMECS graft to restore the occular surface tissue of patients with total limbal stem cell deficiency

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 82

Inclusion Criteria

Inclusion criteria for all patients:
1. Age =2 years to 74 years
2. Males or females with bilateral or unilateral total LSCD due to one of the following causes:
a) Chemical burns
b) Thermal burns
c) Contact lens wear
d) Surgery of the ocular surface
e) Stevens-Johnson syndrome and other inflammatory disease under stable condition
f) Aniridia
3. Documented conjunctivalization of the corneal surface, measured by fluorescein staining
4. Stable disease, i.e. history of LSCD for at least 6 months
5. Clinical signs indicative of conjunctivalisation:
a) Superficial blood vessels on the corneal surface
b) Loss of epithelial transparency or persistent epithelial defect
6. Healthy oral mucosa
7. Absence from tobacco and alcohol (7 days before the biopsy)
8. Regular tooth brushing (at least twice daily)
9. Ability to comply with the protocol
10. Covered by a social security system
11. Signed informed consent form, ability to understand the study procedures, and contractual capability. Applicable to patient or legal carer (including parent)

Special inclusion criteria for patients between 18 and 74 years of age (adults):
12. Multiple surgeries in the limbal region
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Exclusion criteria for all patients:
1. Acute systemic infection
2. Acute ocular inflammation in the previous 6 months
3. Previous neoplastic/cancer disease
4. Severe dry eye confirmed by a Schirmer test
5. Lyell-Syndrome, epidermolysis bullosa
6. Total symblepharon
7. Medical history of hypersensitivity or allergy to bovine or murine derived materials
8. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
9. Any systemic infectious disease as diagnosed by serology tests such as syphilis, HIV-1, HIV-2, hepatitis B or C, or HTLV-1 infection at screening and at the day of the biopsy
10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study
11. Previous participation of the patient in this study
12. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications
13. Employees of the sponsor or patients who are employees or relatives of the investigator
14. Genetic conditions such as ectodermal dysplasia or multiple endocrine neoplasia

Special exclusion criteria for patients =2 and <18 years of age (children):
15. Multiple surgeries in the limbal region

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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