A clinical study to follow the implantation of Holoclar on the cornea in patients with occular burns

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 92

Inclusion Criteria

1. Written informed consent prior to any study-related procedures;
2. Adult male and female patients (=18 years old) - [Five Paediatric
patients aged 2 to 17 years will be also enrolled for safety purposes
only];
3. LSCD secondary to unilateral or bilateral physical or chemical
ocular burns, with at least 1-2 mm2 of undamaged limbus to harvest
stem cells for expansion in culture. LSCD will be considered for inclusion
in presence of superficial neo-vascularization invading at least two
corneal quadrants with evidence of central corneal (central 6 mm
diameter) involvement (including central corneal neo-vascularisation or
corneal opacity) according to the independent assessors;
4. Stability of LSCD, defined by a duration of disease of at least 24
months (12 months for minors) at the time of the Screening Visit and as
presence of continuum epithelium as per fluorescein staining scored as
none or trace;
5. Presence of severe impairment in visual acuity defined by a score
after best correction (i.e. Best Corrected Visual Acuity) equal or below
1/10 (or 20/200) at the Snellen chart (legal blindness);
6. Absence of other clinical contraindications to ACLSC transplantation based upon investigator’s judgment;
7. A cooperative attitude to follow up the study procedures (Caregivers in case of minors).
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 73
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. LSCD of mild degree (i.e. below 2 quadrants of vascularization
invasion), due to a recent burn (less than 24 months before screening
for adults and 12 months for minors), or secondary to medical conditions
other than burns (i.e. radiotherapy);
2. Severe ocular inflammation according to the Efron Grading Scale for Contact Lens Complications. Patient can be re-screened after appropriate treatment;
3. Presence of eyelids malposition;
4. Conjunctival scarring with fornix shortening;
5. Tear secretion deficiency, determined by Schirmer’s test (<5 mm/ 5 min);
6. Corneal anaesthesia and conjunctival anaesthesia or severe hypoesthesia;
7. Clinically significant or unstable concurrent disease or other
clinical contraindications to stem cell transplantation based upon
investigator’s judgment or other concomitant medical conditions
affecting grafting procedure (i.e. use of contrast medium in the
last two weeks) or any other invasive procedure which could
affect the integrity of the epithelium

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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