The solution for graft preservation
The annual number of transplants is constantly increasing in France, from 4,580 in 2009 to 6,105 in 2017.However, this still falls well short of demand. In 2017, 23,828 patients were waiting for organs1. 400 to 500 people on the transplant waiting list dies due to the lack of available organs.
Faced with this shortage, regulatory and health authorities have authorized the use of organs from older and older donors and from donors who suffered cardiac death. Organs from such donors are very sensitive to the ischemia-reperfusion cycle.
In the USA, more than 123,000 people are waiting for transplants2. Yet, one in eight organs collected is not transplanted because there is too much time between collection and transplantation.
During a transplant of “solid” organs, the organ removed is experiencing a sudden stop of blood supply and therefore the oxygen necessary for its survival (i.e. ischemia). It is then usually placed in a 4°C preservation solution to reduce its metabolism (Figure 1).
Ischemia/reperfusion can lead to lesions due to the lack of oxygenation of the graft, and these play an important role in the risk of primary rejection of the graft by the recipient. Ischemia/reperfusion can lead to lesions due to the lack of oxygenation of the graft, and these play an important role in the risk of primary rejection of the graft by the recipient.
The challenge is therefore major to provide solutions to limit these lesions and thus improve the quality of the grafts.
In this context, the HEMO2life® medical device developed by Hemarina represents a breakthrough innovation in the field of organ preservation. HEMO2life® is an additive to organ preservation solutions, allowing the graft to be oxygenated physiologically and thus considerably reducing the risk of graft rejection and extending the storage time of the grafts.
HEMO2life® has already been tested on several pre-clinical models, and has been the subject of a clinical study in kidney transplantation (OxyOp) led by Prof. Yannick Le Meur (CHRU Brest) and Prof. Benoît Barrou (APHP, Pitié-Salpêtrière Paris), that included 60 patients, at 6 primary French transplantation centres with remarkable results.
In 2018, HEMO2life® was also used during a patient’s second total face graft, performed by Professor Lantiéri (Georges Pompidou European Hospital). The immediate benefit of the widespread use of this technology would be twofold: to provide transplant surgeons with organs in excellent physiological conditions and provide better preservation conditions for the graft while it is in transit. This would increase the time the organ could survive between the time of collection and transplantation to the recipient,
which preliminary results of the OxyOp clinical study showed that preserving the graft with HEMO2life® allows a better recovery of the transplanted organ’s function and would thus increase the success rate of the grafts performed.
Today, harvested organs can only survive a few hours post removal, after which time they lose their metabolic functions and intrinsic quality 3. Hemarina’s, HEMO2life® allows longer possible preservation time of the harvested organs. 3 HEMO2life® can be easily integrated into current hospital practices and could greatly facilitate the organisation of the transplant by giving medical staff more time to prepare the transplant. Hemarina submitted a “CE” marking application file in 2018 to a notified body.
1. Biomedicine Agency, press release, March 2018
2. Number of candidates for transplantation in the United States in 2015, Statista, 2019
3. From 3 hours for a heart, to 24 hours for a Kidney, Biomedicine Agency, Organ Donation, https://www.dondorganes.fr
HEMO2life® : Related Publications
Latest press releases
Hemarina and Delpharm announce the signing of a partnership for the manufacture of HEMO2life®
November 29, 2018
Brest University Hospital and HEMARINA present the new positive advances of the first clinical trial of HEMO2life® at the American Transplant Congress in Seattle,
June 6, 2018
Hemarina and the University Health Network of Toronto announce positive preclinical proof of concept results for the HEMO2life® oxygen transporter in the preservation of lung transplants before transplantation
April 12, 2018
Brest University Hospital and HEMARINA announce positive results from the first clinical trial of HEMO2life® in kidney conservation before transplantation in humans.
November 14, 2017