A clinical study to follow up the implantation of Holoclar on the cornea of patients with ocular burns

Phase 1

• Conditions: Corneal lesions with associated moderate to severe limbal stem celldeficiency due to ocular burns; MedDRA version: 20.0Level: LLTClassification code 10011012Term: Corneal epithelium opacitySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-001344-11-ES
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

All patients (adults and pediatrics) who completed the HOLOCORE
core study and who consent to roll over to the present extension
study at the end of the HOLOCORE follow-up.
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

No specific exclusion criterion is considered for this study, except for
patients dropping out from the HOLOCORE study or withdrawing
consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified