Holoclar 300,000-1,200,000cells3.8square cm living tissue equivalent

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Autologous human corneal epithelial cells

Available from:

Chiesi Ltd

INN (International Name):

Autologous human corneal epithelial cells

Dosage:

197500Cell/1square cm

Pharmaceutical form:

Living tissue equivalent

Administration route:

Intraocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

1
CP0049-3
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 new cells. Thes

Summary of Product characteristics

OBJECT 1
HOLOCLAR
Summary of Product Characteristics Updated 07-Feb-2018 | Chiesi
Limited
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
This medicinal product is intended for autologous use only.
Holoclar must be administered by an appropriately trained and
qualified surgeon and is restricted to
hospital use only.
Posology
The amount of cells to be administered is dependent on the size
(surface in cm
2
) of the corneal surface.
Each preparation of Holoclar contains an individual treatment dose
with sufficient number of cells to
cover the entir