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 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 central corneal involvement (including corneal neo-vascularisation, corneal opacity or corneal dyschromia) according to the independent assessors;
4.      Stability of LSCD, defined by a duration of disease of at least 24 months at the time of the Screening Visit and presence of continuum epithelium as per fluorescein staining scored as none or trace;
5.      Presence of severe impairment in visual acuity at the Snellen chart (legal blindness) after best correction (i.e. Best Corrected Visual Acuity);
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 neo-vessel invasion without central corneal), due to a recent burn (less than 24 months before screening), 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe (at least two corneal quadrants, central corneal involvement resulting in severe visual impairment) LSCD secondary to ocular burns.;Secondary Objective: To evaluate the efficacy of one or two treatments with Holoclar at one year after the last treatment. ;Primary end point(s): - Percentage of patients with a success of transplantation (success is defined on the basis of the degree of superficial corneal neo-vascularization” and epithelial defects”);Timepoint(s) of evaluation of this end point: 12 months from the first Holoclar treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Percentage of patients with clinical success after one or two ACLSCTs (same definition of success as primary endpoint)<br> ;Timepoint(s) of evaluation of this end point: 12 months after the last treatment with Holoclar.<br>

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