Thread: Vitrolife: Two Lung Transplantations Performed In Manchester Using New Technology

Vitrolife: Two Lung Transplantations Performed In Manchester Using New Technology

17 Dec 2008

The University Hospital of Manchester, England, is now the first clinic outside Sweden to have used the STEEN Solution™ method clinically. Two double lung transplantations have been performed with positive results. "It is exciting to note that Steen Solution™ and lung evaluation outside the body are beginning to become clinical practice in a leading country such as the UK, and that more people with lung disease thereby receive effective treatment," says Magnus Nilsson, CEO of Vitrolife.

At the beginning of September Vitrolife announced that a lung transplantation had been performed for the first time using the STEEN Solution™ technology outside Sweden. Earlier on in the development and the first clinical use eight transplantations have been carried out using STEEN Solution™ at the University Hospital of Lund, where the technology was developed under the leadership of Professor Stig Steen.

The University Hospital of Manchester that performed the transplantation has now performed one further transplantation. According to Nizar Yonan, the hospital's Transplant Director, both the transplantations were successful. Nizar Yonan says to the BBC that the method means that "we can have a better idea of those lungs and their function". Due to the STEEN Solution™ method, which offers an opportunity to test the lung's function outside the body, lungs could be used which would have been out of the question without the aid of the technology. Kenneth Collins, who has suffered from COPD (chronic obstructive pulmonary disease), is the first patient in the UK and is grateful to have got his life back. He says to the BBC that after the operation he feels "at least ten to fifteen years younger".

With the STEEN Solution™ method, the number of potential organs that can be transplanted increases considerably. In the USA, for example, less than 20 percent of the lungs donated are transplanted today, due to uncertainty about the function of the organ. In time the STEEN Solution™ method can lead to a fivefold to tenfold increase in the number of lung transplantations carried out, as the need for donated organs using today's methods considerably exceeds supply.

STEEN Solution™ is approved for sales in Europe, that is it is CE marked. At present a clinical study is ongoing in Canada using STEEN Solution™, which will form the basis of an application for sales approval in the USA and Canada.

Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation. The Fertility product area works with nutrient solutions (media) and advanced consumable instruments such as needles and pipettes, for the treatment of human infertility. The Transplantation product area works with solutions and systems to maintain tissue in optimal condition outside the body for the required time while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.

Vitrolife today has approximately 140 employees and the company's products are sold in more than 80 markets. The head office is in Gothenburg, Sweden, and there are subsidiaries in USA, Australia and Italy. The Vitrolife share is listed on the OMX Nordic Exchange Stockholm's Nordic Small Cap list.


---------------------

For your Reference:

STEEN Solution™

STEEN Solution™ ex-vivo assessment could expand your donor lung pool.
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor for eventual transplantation into a recipient.

About four of every five lungs offered for transplantation are currently rejected by present selection criteria. 1, 2 However, lungs from marginal and extended donors have been sucessfully used for transplantation for at least a decade and the concept is gradually gaining acceptance.3, 4, 5

The ex-vivo assessment of marginal lung function, including gaseous exchange, at 37 ºC was orginally developed for non heart beating donor lungs by Steen et al6, 7 and has since been adopted by other centers.8, 9.

Closed circuit perfusion of the lung mimics in-vivo conditions; the ventilated lung is perfused with a 15% deoxigenated suspension of red cells in STEEN Solution™ and the circuitry monitors critical parameters of gaseous exchange, pulmonary vascular resistance and other key variables under normothermic conditions. The STEEN Solution™ perfusate and circuitry can maintain stable lung function, without oedema formation, for at least two hours at 37 ºC.7, 8

The STEEN Soultion™ perfusate and machine perfusion methodology permit:

• A more refined functional ex-vivo evaluation of accept/reject criteria
• Normothermic functional evaluation without oedema formation
• Permits more rational allocation and use of donor lungs

How to use STEEN Solution™
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor for eventual transplantation into a recipient.

See Picture in Attachment


Lung evaluation set-up

The lungs or the heart-lung block are enclosed in a transparent plastic container to maintain suitable humidity. The “venous” afferent side of the closed circuit is connected to a heat and gas exchanger so that the perfusate, STEEN Solution™ plus 15% red blood cells, assumes the temperature and partial gas pressures of normal venous blood. A leucocyte filter is connected before the inflow to prevent leucocyte-induced tissue injury.


Perfusion pressure is closely monitored and is not permitted to exceed 20 mm Hg to avoid the risk of oedema formation. Since the lungs are generally cold before perfusion, initial flow rates must be very low, gradually increasing as the temperature increases. The flow should never exceed 4 l/min. Careful ventilation is begun as the temperature of the perfusate outflow reaches 32 °C and full ventilation is begun as it reaches 37 °C.

Functional assessment can begin when the circuit has reached the steady state described above, monitoring arterial and venous blood gases, endtidal carbondioxide and a range of hemodynamic parameters.

For research purposes only in the US.



STEEN Solution™ contains
Human Serum Albumin - provides normal oncotic pressure preventing oedema formation
Dextran - a mild scavenger which coats and protects endothelium from subsequent excessive leucocyte interaction10, 11 and thrombogenesis.12
Extra-cellular electrolyte composition (low K+) - reduces free radical generation13 and avoids vascular spasm under normothermic conditions.
-----------


Schematic drawing of lung assessment ex vivo

Schematic drawing of lung assessment ex vivo

PAP=pulmonary-arterial pressure
LAP=left-arterial pressure