EUCTR2015-001344-11-FR
Active, not recruiting
Phase 1
Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns (HOLOCORE-FU) - HOLOCORE F
Conditionscorneal lesions with associated moderate to severe limbal stem celldeficiency due to ocular burnsMedDRA version: 20.0Level: LLTClassification code 10011012Term: Corneal epithelium opacitySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsHOLOCLAR
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- corneal lesions with associated moderate to severe limbal stem celldeficiency due to ocular burns
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 59
- •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
Outcomes
Primary Outcomes
Not specified
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