What is Holoclar and what is it used for? Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).

The European Commission has given Holoclar ®, the first advanced therapy medicinal product (ATMP) containing stem cells, conditional marketing authorisation following a recommendation for approval by the European Medicines Agency.

Holoclar is an SC-based treatment used to replace damaged cells on the surface of the cornea, the transparent layer located at the front of the eye and covering the iris, which is the colored part. It is used in adult patients suffering from a limbic SC deficiency caused by chemical eye burns.

HOLOCLAR®: the first stem cell based ATMP classified as tissue engineered product (TEP) Holoclar is a Stem C ells ( SCc)-based treatment used to replace damaged cells on the surface of the cornea. Holoclar consists of a transparent circular sheet of 300,000 –1,200,000 viable autologous human corneal epithelial cells.

Holoclar is intended solely for use in autologous limbal stem cell regeneration in line with the approved therapeutic indication and should be administered under aseptic conditions in conjunction with limbal peritomy, undermining of the conjunctiva and excision of the corneal fibrovascular tissue

Apr 5, 2024 · Holoclar is a therapy consisting of an ex-vivo reconstructed autologous human corneal epithelium containing stem cells. This step had received, at the end of 2023, a positive opinion from the CHMP (Committee for Medicinal Products for Human Use) of EMA, the European Medicines Agency, following the completion of the interventional and ...

Mar 3, 2015 · What exactly is Holoclar and how does it work? The surface of the cornea — the transparent tissue that sits in front of the iris — is constantly renewed in a healthy eye, to keep it smooth and ...

Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 – 316,000 cells/cm²), including on average 3.5% (0.4 to 16%) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin ...

Jul 6, 2016 · Holoclar comprises ex-vivo expanded autologous human corneal epithelial cells containing stem cells used for treating moderate-to-severe Limbal Stem cell deficiency (LSCD) caused by physical or chemical ocular burns. Such damage can …

Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells), a novel treatment for eye burns, is one of the few ATMPs to have been granted marketing authorization and is the first containing stem cells.

Holoclar was shown to successful-ly reverse the damage to cornea, restore healthy tissue and further facilitate the success of subsequent keratoplasty when needed (i.e., in cases of deep penetration of the burn injury in the corneal stroma). Holoclar is manufactured starting from a small biopsy of 1–2 mm2 of undamaged limbus,

Jun 14, 2018 · GPLSCD01, known as Holoclar in the European Union, is the first medicine containing stem cells to be licensed in the EU for the treatment of adult patients with moderate to severe limbal stem cell deficiency in one or both eyes due to physical or chemical ocular burns.

Dec 19, 2014 · Holoclar is a treatment for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. It is the first medicine recommended for LSCD, a rare eye condition that can result in blindness.

Feb 23, 2015 · Chiesi, a privately held Italian company, has received approval in the EU for Holoclar for the treatment of eye burns. Specifically, Holoclar is intended for treatment of limbal stem-cell deficiency due to physical or chemical burns.

Holoclar is intended solely for use in autologous limbal stem cell regeneration in line with the approved therapeutic indication and should be administered under aseptic conditions in conjunction with limbal peritomy, undermining of the conjunctiva and excision of the corneal fibrovascular tissue

The Scottish Medicines Consortium (SMC) has assessed Holoclar® for treating adult patients with moderate to severe limbal stem cell deficiency caused by physical or chemical burns to the eye. This document summarises the SMC decision and what it …

HOLOCLAR is a first-line treatment in the treatment of bilateral moderate to severe LSCD, caused by chemical or physical eye burns, that meets the following criteria: presence of a superficial corneal neovascularisation in at least two quadrants of …

May 23, 2023 · Holoclar was developed based on more than twenty years of research by a team of internationally renowned scientists in the field of epithelial stem cell biology. It is an ex vivo expanded autologous human corneal epithelial cells containing stem cells, capable of restoring eyesight of patients with severe cornea damage due to ocular burns, and ...

Holoclar is a medicine used for replacing damaged cells of the cornea (the clear layer that covers the coloured iris at the front of the eye) including limbal cells which normally help to maintain the health of your eye.

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.