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

Phase 1

• Conditions: corneal lesions with associated moderate to severe limbal stem cell deficiency due to ocular burns; MedDRA version: 18.0Level: LLTClassification code 10011012Term: Corneal epithelium opacitySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-002845-23-FR
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-11
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• 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