Holoclar

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

ex vivo expanded autologous human corneal epithelial cells containing stem cells

MAH:

Holostem s.r.l

ATC_code:

S01XA19

INN:

ex vivo expanded autologous human corneal epithelial cells containing stem cells

therapeutic_group:

Ophthalmologicals

therapeutic_area:

Stem Cell Transplantation; Corneal Diseases

therapeutic_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.

leaflet_short:

Revision: 10

authorization_status:

Authorised

authorization_date:

2015-02-17

PIL

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HOLOCLAR 79,000 – 316,000 CELLS/CM
2
LIVING TISSUE EQUIVALENT
_Ex vivo_
expanded autologous human corneal epithelial cells containing stem
cells.
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your surgeon.
-
If you get any side effects, talk to your surgeon. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Holoclar is and what it is used for
2.
What you need to know before you are given Holoclar
3.
How Holoclar is given
4.
Possible side effects
5.
How Holoclar is stored
6.
Contents of the pack and other information
1.
WHAT HOLOCLAR IS AND WHAT IT IS USED FOR
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.
Holoclar consists of a layer of your own cells which have been grown (
_ex vivo_
expanded) from a
sample of limbal cells taken from your eye during a small surgical
procedure called a biopsy. Each
preparation of Holoclar is made individually and is for a single
treatment only, although treatments can
be repeated. The cells used to make Holoclar are known as autologous
limbal cells:
•
AUTOLOGOUS
means that they are your own cells.
•
The
LIMBUS
is part of the eye. It is the rim surrounding the coloured centre
(iris) of your
eye. The picture shows where the limbus is in your eye.
•
The limbus contains
LIMBAL CELLS
which normally help to maintain the health of your
eye and some of these are
STEM CELLS
which can make

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Holoclar 79,000 - 316,000 cells/cm
2
living tissue equivalent
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
_Ex vivo_
expanded autologous human corneal epithelial cells containing stem
cells.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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/ cm
2
), 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 layer and maintained in the
transport medium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Living tissue equivalent.
Transparent, circular sheet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 mm
2
of undamaged limbus is required for biopsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Holoclar must be administered by an appropriately trained and
qualified surgeon and is restricted to
hospital use only.
_ _
Posology
This medicinal product is intended for autologous use only.
The amount of cells to be administered is dependent on the size
(surface in cm²) of the corneal surface.
Each preparation of Holoclar contains an individual treatment dose
with sufficient number of cells to
cover the entire corneal surface. The recommended do