CytoSorb With Ex Vivo Organ Perfusion: Transforming The Future Of Solid Organ Transplantation
PRINCETON, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Cytosorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery, uses patented polymer adsorption technology to purify blood, highlights the growing rate ex vivo organ perfusion in organ transplantation and the important role played by CytoSorb® and ECOS-300CY® in this new field. In particular, these technologies can help improve the quality and quantity of usable organs while increasing transplant success rates. Importantly, evidence from recent peer-reviewed publications shows how these innovative treatments can improve outcomes in specific lung transplant cases.
Background Information - Organ Transplantation, Ex Vivo Organ Perfusion and CytoSorb/ECOS-300CY
Organ transplantation is the gold standard treatment for end-stage organ failure. However, suitable organ donors are rare, and many patients often die while waiting for an organ to become available. According to the World Observatory on Donation and Transplantation, approximately 158,000 solid organs were transplanted worldwide in 2022. According to the United Network for Organ Sharing (UNOS) and the European Organization for Quality in Medicine and Healthcare (EDQM), the US and US transplant waiting lists will have roughly the same number of patients, around 153,000, in 2022. The EU stands alone, largely because for the lack of competent institutions. Every 10 minutes someone is added to the waiting list, and every half hour or so someone on the waiting list dies waiting for an organ that never arrives.
Most organ donations come from deceased donors, often due to irreversible heart or brain death. However, due to a number of factors including ischemia and reperfusion injury, refrigerated storage, and the manner of death of the donor, these organs are often damaged by significant inflammation, compromising the health of the organs and, more importantly, the success of the harvest. Transplantation. In the United States, according to a 2020 Millman research report, a single lung transplant costs about $930,000, a double lung transplant: $1.3 million, a kidney transplant: $443,000, a liver transplant: $878,000, and a heart transplant: $17 million dollars. . Due to the cost of rejection, many organs are discarded even though they are desperately needed. In addition, many organs, although considered suitable for transplantation, have problems with delayed graft function or early graft dysfunction after surgery. This is different from organ rejection and can occur in any organ. For example, in lung transplantation, the incidence of fatal pulmonary failure, called severe primary graft dysfunction (SPG), can be as high as 30% in the first few days after transplantation, resulting in a high incidence within 90 days. 20-25%), and annual mortality (30-35%) without PGD is 3-5 times higher. Strategies that can improve organ health or postoperative outcomes are important for the future of organ transplantation.
Ex vivo organ perfusion is an increasingly used method to preserve and potentially improve lung, heart, liver, and kidney function by reducing ischemic, reperfusion, and storage injuries after organ retrieval and during transport. Cold caused by traditional static cold storage. It is also possible to increase the number of available donor organs by preserving low-quality organs that would otherwise be discarded. Ex vivo perfusion involves circulating an oxygenated, nutrient-rich fluid or temperature-controlled blood product throughout an organ to improve function. However, ex vivo perfusion does not adequately explain the continuous release of cytokines and other inflammatory mediators produced by the injured organ, which causes persistent damage and dysfunction. Based on current data, we believe that our cytokine adsorption technology (eg, CytoSorb, ECOS-300CY) has the potential to revolutionize the field of organ transplantation using ex vivo organ perfusion. Organs not only through improved preservation and rehabilitation of organs. Taking it to the next level but improving clinical outcomes after surgery. The combination has so far been used successfully in heart, liver and kidney transplants, but most of the data comes from lung transplants.
Cytosorb and ECOS-300CY for lung transplantation
The final analysis of cytosorb therapy in the COVID-19 registry (CTC) was recently published in the journal Critical Care and found that the combination of cytosorb and extracorporeal membrane oxygenation (ECMO) therapy resulted in recovery after 90 days in 100 patients. The 74% survival rate included patients from the 5 largest US ECMO centers suffering from COVID-19 with severe acute respiratory distress syndrome (ARDS) and ventilator failure. This compares favorably with the 90-day survival rate reported by the Extracorporeal Life Support Organization (ELSO), which was 52% in more than 15,000 COVID-19 patients who used ECMO alone. The article describes the concept of “enhanced lung rest,” which involves the use of Cytosorb to eliminate inflammatory cytokines and toxins that can cause or worsen lung damage due to capillary leak syndrome, pulmonary edema (i.e., fluid in the lungs), and severe inflammation. . . The ultimate goal of CytoSorb therapy is to stop severe inflammation and promote healing and repair of the lungs.
The same concept of “prolonged lung dormancy” applies to lung transplantation, where inflammation of the donor lung causes the same capillary leak syndrome, pulmonary edema, and pulmonary dysfunction and, as previously noted, is a major factor in early graft dysfunction (PID). ).
In 2017, Iskender and Inci et al. In the first study published in the Journal of Heart and Lung Transplantation of the University Hospital of Zurich in Switzerland, Cytosorb was used with ex vivo lung perfusion (EVLP) in a controlled porcine lung model and showed that decreased blood flow with the help of cytokines reduces microscopic damage to the lungs. , enhanced. Improving electrolyte balance and lung mechanics facilitates ventilation. In 2021, the team published a follow-up study in the Journal of Heart and Lung Transplantation in which they took the model to the next level by transplanting EVLP-treated lungs (with or without cytosorb) into pigs. They found that EVLP with CytoSorb significantly improved the function of the transplanted lungs in terms of mechanical and gas exchange.
In a landmark paper published in the prestigious journal Nature Communications in 2022, Haydon and Lindstedt et al. et al examined the effects of CytoSorb and EVLP in a porcine lung transplantation model. Endotoxin injection causes lung injury and ARDS in donor pigs. After collection, these damaged lungs were transplanted with EVLP and separate lungs from a new recipient pig. The study was divided into three groups. The “ no treatment ” group never received Cytosorb. The "treated" group was divided into: a) a " single-stage " group, which did not receive CytoSorb at the time of EVLP, but received CytoSorb before surgery after lung transplantation, and b) a "staged" group . In two stages , both of which received EVLP time. EVLP was then reintroduced intraoperatively after CytoSorb lung transplantation. In a detailed, well-controlled study, the researchers monitored numerous parameters including blood and lung cytokines and inflammatory cells, severity of pneumonia, gross histopathological and pathological changes in the lungs, and many clinical parameters including lung recovery. function, oxygenation, hemodynamic stability and development of severe primary graft dysfunction (PID) (grade 3). Importantly, the level of PGD in the first 72 hours after transplantation, which directly correlates with the risk of death, was significantly lower with CytoSorb. The researchers found that 83% (5/6) in the two-stage group and 50% (2/4) in the one-stage group had no PID, compared with 83% (5/6) in the no-stage group. group. staged treatment group that developed severe grade 3 PGD. Overall, the investigators concluded that the use of CytoSorb both during EVLP and in post-transplant recipients was more effective in almost every measure compared with no or no use of it alone. After replacement. They concluded that this picture demonstrates the use of Cytosorb:
“(i) reduces inflammation during EVLP and restores lung function, (ii) restores function and reduces inflammation after transplantation, and (iii) reduces the incidence of PGD (primary graft dysfunction) in transplant recipients.” The work described here is entitled “Use of Cytokine Adsorbers in the Context of Lung Transplantation Using Severely Injured Donor Lungs.” Thus, it is suggested that aspiration may be an intervention that may lead to the acceptance of more lungs for transplantation. This may further improve the recipient's tolerance of this lung, a necessary outcome given that PGD continues to be a leading cause of early mortality and contributes to the development of chronic graft dysfunction.
Building on this work, Professor Sandra Lindstedt and her team at Lund University Hospital in Sweden are now conducting a randomized controlled pilot trial of Cytosorb in ten lung transplant patients. They recently published a short report based on the first four human lung transplant participants, two of whom received Cytosorb during surgery and two of whom did not. Patients receiving CytoSorb had lower levels of circulating nucleosomes (inversely correlated with ILD) and did not develop ILD, whereas two patients not receiving CytoSorb had higher levels of nucleosomes and developed grades 1 and 3 (severe) ILD after surgery .
Recently, Professor Massimo Boffini from the University of Turin in Italy and his team published in the journal Transplant International the largest retrospective human clinical study to date examining the feasibility and safety of CytoSorb® absorption during EVLP. From July 2011 to March 2020, doctors performed a total of 54 EVLP procedures on lungs that were not initially suitable for transplantation. Of these, 33 were performed without Cytosorb and 21 with Cytosorb and integrated EVLP. Of the 38 patients who ultimately underwent lung transplantation, the Cytosorb group had significantly lower perfusate cytokine levels than the control group: 76% (16/21) of the lungs in the Cytosorb group were treated with EVLP. Compared with 67% (22/33) of untreated control patients eligible for transplantation. Importantly, lung transplant patients receiving CytoSorb during EVLP had significantly lower in-hospital mortality (0% vs. 13%; p=0.03) and higher 1-year mortality. less (0% vs. 36%; p = 0.01). compared to those whose lungs received EVLP alone. In addition, the use of CytoSorb was associated with a trend towards fewer severe grade 3 ART cases and a reduced need for ECMO support, possibly associated with significant cost savings. These results were observed even though none of these patients received additional Cytosorb treatment either intraoperatively or postoperatively.
Dr. Philip Chen, MD, CEO of CytoSorbents, said, “Overall, these data are very exciting for several reasons. First, the data demonstrate the potentially important role of our cytokine adsorption technologies, including CytoSorb and ECOS-300CY, specifically approved in the EU for ex vivo organ perfusion, in lung transplantation. We see many opportunities to improve lung graft function, expand the transplantable lung donor pool through poor quality lung reconstruction, and most importantly, reduce severe early graft dysfunction and mortality. Second, although lung transplantation is not as common as kidney or liver transplantation, we believe that the basic principles of reducing cytokine levels and treating inflammation in the organ and host will provide benefits similar to other organ transplants. For example, Hosgood and colleagues reported that ex vivo renal perfusion with Cytosorb reduced inflammation and inflammatory mediators and improved renal perfusion in porcine kidneys. One of our major partners, Aferetica, is currently working with transplant surgeons to study our technology known as PerSorb®, their PerLife® ex vivo organ perfusion system, human kidney and liver transplantation, and lung transplantation on the PerLungs® platform. We plan to increase awareness of this publication and ideas within the transplant community to encourage more innovation and opportunity in this field.
Dr. Chan continued: “In conclusion, these important data support CytoSorb's ability to improve lung function in a variety of settings and, more importantly, provide mechanistic evidence for how CytoSorb may help treat lung distress. Acute Respiratory Syndrome (ARDS) Promoting Rest Even Before the Covid pandemic, ARDS was common and was diagnosed in approximately 10% of all intensive care unit admissions. During the H1N1 influenza pandemics in 2009 and the Covid-19 influenza pandemics in 2020–2022. death was We believe that CytoSorb represents a new innovation for the treatment of ARDS with significant sales potential.
Commenting specifically on Boffini's study, the CEO of Aferetica SRL, Mr. Mauro Atti, said: “This published study is the result of a project launched in 2015 in collaboration with the City of Health and Sciences Hospital of the University of Health and Sciences of Turin in the organ field. replacement, where researchers were among the first to use CytoSorb for this purpose. In fact, their early discoveries in CytoSorb were instrumental in the development of our PerLife® and PerLungs® platforms for perfusion and clearance of the liver, kidney and lungs. both are perfectly integrated into the PerSorb® sorbent, which CytoSorbents provides to us as part of an international strategic agreement. These data show how organ perfusion and purification can restore peripheral organs, reduce side effects after transplantation, and even improve the survival of transplant patients - further supporting our correct decision to invest in this area and collaborate with CytoSorbents.
CytoSorbents Corporation (NASDAQ:CTSO )
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care units and cardiac surgery through blood purification. Its flagship product CytoSorb® is approved in the European Union, distributed worldwide in 75 countries and has treated more than 212,000 people to date to reduce cytokine storm and other toxins that can cause organ failure. Based on the same polymer technology as CytoSorb, the DrugSorb™-ATR Antithrombotic Removal System has received two breakthrough device designations from the US FDA for the removal of two different anticoagulants during cardiothoracic surgery, specifically ticagrelor and the direct oral anticoagulants (DOACs) apixaban and rivaroxaban. → আরও তথ্যের জন্য, অনুগ্রহ করে কোম্পানির ওয়েবস াইটগুলি www.cytosorbents.com এবং www.cytosorb.com এ যান বা Facebook এবং Twitter-এ আমাদের অনুসর ণ করুন৷
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