Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells)
- Region
- 🇪🇺 EU
- Active substance
- ex vivo expanded autologous human corneal epithelial cells containing stem cells
- Company
- Holostem s.r.l.
- Status
- Authorised
- Therapeutic area
- Stem Cell Transplantation; Corneal Diseases
- CHMP opinion
- Thu 18 Dec 2014
- EU approval
- Tue 17 Feb 2015
- Designations
- ATMP, Additional monitoring
- Application
- EMEA/H/C/002450
- ATC
- S01XA19
- Official record
- www.ema.europa.eu
Indication
Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.