Our products

Our static preservation systems, comprised of specially formulated solutions and insulated shippers, provide safe and consistent method for cold ischemic storage and transport of donor organs. Our systems are adequate for all type of abdominal and thoracic organs.

Celsior

Solution for the preservation of thoracic organs (heart and lung) and abdominal organs (kidney, liver, and pancreas) during transplantation:
From removal from the donor as well as during storage, transportation and until transplantation into the recipient.

In the US, the use of CELSIOR® for preservation of organs, other than hearts, has not been approved by the FDA.

Description
Product features

Each bag with 1 litre solution contains:

Glutathione : 0,921 g (3 mmol)
Mannitol : 10,930 g (60 mmol)
Lactobionic acid : 28,664 g (80 mmo)l
Glutamic acid : 2,942 g (20 mmol)
Sodium hydroxide : 4,000 g (100 mmol)
Calcium chloride dihydrate : 0,037 g (0,25 mmol)
Potassium chloride : 1,118 g (15 mmol)
Magnesium chloride hexahydrate : 2,642 g (13 mmol)
Histidine : 4,650 g (30 mmol)

The other excipients are:

Water for injections
Sodium hydroxide, 4% (pH adjustment)

PACKAGING

Celsior® is marketed in a 1000ml bag. Ethylene Vinyl Acetate Copolymer (EVA) bag is overwrapped with an aluminum protective overbag to protect from light. An oxygen absorber is placed in overbag to reduce degradation of the solution components.

REGULATORY STATUS

Europe : Drug
World (Outside EU) : Medical Device

Infos

Ensure complete flushing of blood
Decrease enzyme activity ol the organ (hypothermic)
Ischaemic reperfusion damage (IRI) reduction:
1. Prevention of oxidative damage: reduced glutathione,
  histidine, lactobionate and mannitol
2. Prevention of hypothermia-induced cellular swelling and oedema: membrane-impermeable substances mannitol and lactobionic acid
3. Prevention grafts from tissue acidosis: histidine
4. Regeneration of high-energy substances: glutamate
5. Protecting against calcium overload : low potassium, low calcium and high magnesium content.

Celsior is an extracellular solution:
Na=100 mmol/L
K=15 mmol/L.