HOLOCORE-FU
Research type
Research Study
Full title
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)
IRAS ID
249754
Contact name
Sajjad Ahmad
Contact email
Sponsor organisation
CHIESI FARMACEUTICI S.p.A
Eudract number
2015-001344-11
Duration of Study in the UK
4 years, 9 months, 0 days
Research summary
This is phase IV multinational, multicenter, prospective, non-interventional, non-pharmacological, follow-up study of the clinical trial HOLOCORE. The purpose of this study is to demonstrate the long term safety of one or two Autologous Cultivated Limbal Stem Cells Transplantations (ACLSCT(s)) with Holoclar® in patients suffering from moderate to severe Limbal Stem Cells Deficiency (LSCD) secondary to ocular burns who received the treatment with Holoclar® in the HOLOCORE study.
All adult patients who completed the core HOLOCORE study will be asked consent to roll over into this extension study at the end of the core study follow-up period, before inclusion. Approximately 65 adult patients will be enrolled in this follow-up study (all patients who completed the core study). This study will be conducted in about 20 hospital centres in 8 European countries (3 sites in the UK).REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1449
Date of REC Opinion
6 Nov 2018
REC opinion
Further Information Favourable Opinion