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Study Shows Significant Positive Effects of CytoSorb Therapy for Septic Shock Patients

Treatment with CytoSorb for cytokine removal in early septic shock shows improvement of clinical condition and inflammatory response

Study Shows Significant Positive Effects of CytoSorb Therapy for Septic Shock Patients

Berlin, Germany, February 14, 2019 – CytoSorbents Europe GmbH announces the publication of positive results of a randomized, controlled pilot study, proving a significant stabilization of the cardio-vascular system of patients who suffered from septic shock and have been treated with CytoSorb® as an early standalone (meaning without combined renal replacement) therapy for extracorporeal cytokine removal.

CytoSorb therapy is based on the first specifically-approved extracorporeal cytokine adsorber – CytoSorb 300 – marketed in the European Union and was designed to reduce the „cytokine storm“ or „cytokine release syndrome“ which is a major contributing factor in deadly inflammation. It is based on a cartridge containing biocompatible, highly porous polymer beads that act like sponges and actively remove harmful substances from the blood.

The pilot study will be published in the February issue of the Journal of Critical Care (49: 172-178) and can be accessed as an Epub under this link. It was authored by a medical team with the Department of Anesthesiology and Intensive Therapy of the University Szeged in Hungary, led by Professor Zsolt Molnar, a leading expert in the research and treatment of sepsis and septic shock. The team investigated the effects of a single treatment of extracorporeal cytokine removal with CytoSorb therapy, in addition to the standard treatments including, for example antibiotics, applied in patients with early stage septic shock (within the first 24 hours after onset of septic shock or after ICU admission). Twenty patients were randomized into a group treated with the CytoSorb therapy (n=10) for 24 hours or a control group (n=10). Clinical and laboratory data was recorded at the baseline and after 12, 24 and 48 hours.

The results show a significant decrease of Big-endothelin 1 (which is involved in the pathologic changes of the vascular system), procalcitonin (PCT) (an important marker of inflammation) and most importantly, norepinephrine doses needed to maintain sufficient cardio-vascular function – a vaso-constructive drug which is supposed to stabilize blood pressure but on the other hand reduces important oxygen supply to tissues as a side effect. The required norepinephrine doses dropped by almost 70% from baseline within 48 hours, in comparison to the group without CytoSorb. This result represents an important improvement for the patients.

The findings of this study demonstrate also that the most profound effects of CytoSorb therapy can take place in the first 12 hours of the treatment and the CytoSorb application could be tailored to the patients“ individual response and clinical course. However, different therapy doses might be useful for the patient, i.e., more than one CytoSorb treatment may be beneficial depending on the clinical situation.

Quotes:
„Our results could serve as important milestones in designing future studies,“ said Professor Zsolt Molnar, the leading author of the study. „An important aspect in the design of this trial was our pragmatic approach, specifically, using only one adsorber per treated patient and the relatively short 48 hour observation period. Our target was to test the hypothesis that cytokine removal could have almost immediate effect on organ dysfunction and inflammatory response. This goal has been reached. In future, we can investigate which is the most sufficient CytoSorb dosage for the individual patient to provide the best personalized care.“

„We are pleased to learn about the final results of Professor Molnar and his team“s pilot study on treating refractory septic shock patients with CytoSorb therapy as a standalone hemoperfusion treatment before the onset of kidney dysfunction,“ said Dr. Jörg Scheier, Senior Medical Director Europe at CytoSorbents. „Professor Molnar“s work provides a significant contribution to the scientific evidence needed to demonstrate the treatment benefits of CytoSorb therapy and, at the same time the results will also be of great help in designing future, larger randomized multi centric trials with an even better definition of optimal patient characteristics and treatment modalities to maximize Cytosorb therapy effects.“

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in new technologies and therapies in intelligent blood purification. CytoSorbents Europe GmbH is a hundred percent daughter company of CytoSorbents Corporation and coordinates the introduction and commercialization of CytoSorbents products worldwide.
Its flagship product, CytoSorb® is the first specifically-approved extracorporeal cytokine absorber in the European Union and it is distributed in more than 50 countries worldwide. CytoSorb was designed to reduce the „cytokine storm“ or „cytokine release syndrome,“ which is a major element of the deadly inflammation often seen in critically-ill patients in the intensive care unit (ICU) and those undergoing complex open heart surgery. CytoSorbents“ purification technologies are based on biocompatible, highly porous polymer beads that act like sponges and actively remove harmful substances from the blood. CytoSorb has been used in more than 56,000 human treatments to date.

CytoSorbents technologies have received non-dilutive grant, contract, and other funding of approximately $25 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (USSOCOM), and others.

For more information, please visit the Company“s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Company-Contact
Cytosorbents
Eva Hildebrandt
Prinzregentenstr. 89
81675 München
Phone: +49 89 41 77 61 -14
E-Mail: cytosorbents@lucyturpin.com
Url: http://www.lucyturpin.com

Press
Lucy Turpin Communications GmbH
Eva Hildebrandt
Prinzregentenstr. 89
81675 München
Phone: +49 89 41 77 61 -14
E-Mail: cytosorbents@lucyturpin.com
Url: http://www.lucyturpin.com

Science Research Technology

Asahi Kasei Medical: New Strategies for blood purification

Asahi Kasei Medical: New Strategies for blood purification

Asahi Kasei Medical Rheofilter (Source: @Asahi Kasei)

Düsseldorf, July 5, 2018 – On May 26, Asahi Kasei Medical, a leading manufacturer of products for hemodialysis and therapeutic apheresis treatment launched the first Apheresis Meeting Industry Symposium within the Industry Symposium program of the 55th ERA-EDTA Congress in Copenhagen. 500 participants joined the Symposium.

Therapeutic apheresis is used to treat a wide range of intractable diseases, such as autoimmune diseases including rheumatoid arthritis, peripheral arterial disease, ulcerative colitis, neurological diseases or lipid disorders. Asahi Kasei Medical, founded in 1974 and the first company to globally introduce the hollow fiber separation technology, is offering therapeutic apheresis products that use membrane separation and selective adsorption technology to enable the treatment of many intractable diseases that cannot be treated using drugs. Therapeutic apheresis is increasingly used in the field of preventive medicine.

The membrane used in hollow fiber separation technology only permits plasma and proteins to pass through. Cellular components such as erythrocytes, leukocytes and thrombocytes are filtered out through the fine pores of the special hollow fibre membrane. Plasma and pathogenic substances can be removed, the plasma can be purified and returned to the patient.

During the Apheresis Meeting Industry Symposium, Professor Antonio Santoro (Bologna, Italy) chaired three sessions on Therapeutic Apheresis respectively held by Professor Lionel Rostaing (Grenoble, France), Dr. Alfonso Ramunni (Bari, Italy) and Professor Christoph Wanner (Würzburg University, Germany).

The first session by Professor Christoph Wanner titled „Lipid Apheresis and PCSK9-Antibodies:
Complementary or Competitive?“ explained how high plasma Lipoprotein(a) levels are related with the risk of myocardial infarction in the general population and which preventive action the apheresis treatment exerts by removing Lipoprotein(a) from patient“s blood.

The second session, „Rheopheresis in peripheral artery disease“ presented by Dr. Alfonso Ramunni, focused on removal of Fibrinogen from patient“s plasma and how it impacts peripheral vascular diseases such as Ischemic Diabetic Foot, Critical Limb Ischemia, Sudden Hearing Loss or Age-Related Macular Degeneration.

The third and last session, held by Professor Lionel Rostaing, „Desensitization in ABO incompatible kidney transplant candidates in order to achieve long term outcome“ explained about apheresis treatment efficiency with graft survival in ABO incompatible patients.

ERA-EDTA (European Renal Association – European Dialysis and Transplant Association), founded in 1963 aims at fostering the advancement of science and clinical work in nephrology, dialysis, renal transplantation, hypertension and related diseases with a strong focus on bettering patient“s health. It counts 7, 253 members.

ERA-EDTA Congress is the International annual scientific event that gathers about seven thousand physicians from Europe and worldwide. This year“s Congress took place in Copenhagen on 24-27 May 2018.

Asahi Kasei Medical
Asahi Kasei Medical is one of the worldwide leading manufacturers of products for hemodialysis and therapeutic apheresis treatment. The company was founded in 1974 as part of the Asahi Kasei Group which employs 35,000 employees worldwide. Asahi Kasei Medical started its activity by producing and selling unique world leading dialyzers. In 1981, the company developed and started to sell filters for therapeutic apheresis and expanded treatment options to contribute to patient“s quality of life. Asahi Kasei Medical has expanded its network worldwide by establishing subsidiaries in Europe, Asia, America and today has about 2,200 employees worldwide.

About Asahi Kasei
Asahi Kasei Corporation is a globally active diversified technology company with operations in the Material, Homes, and Health Care business. The Material division encompasses fibers & textiles, petrochemicals, performance polymers, performance materials, consumables, battery separators, and electronic devices. The Homes division provides housing and construction materials to the Japanese market. The Health Care division includes pharmaceuticals, medical devices, and acute critical care devices and systems. With approximately 35,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.

Asahi Kasei is „Creating for Tomorrow“ with all operations sharing a common mission of contributing to life and living for people around the world. For more information, visit
www.asahi-kasei.co.jp/asahi/en/
www.asahi-kasei.eu/

The Asahi Kasei Group is a diversified group of companies led by Asahi Kasei Corp., with operations in the Material, Homes, and Health Care business sectors. Asahi Kasei distributes its innovative technologies and unique materials on markets worldwide.
With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. Asahi Kasei is „Creating for Tomorrow“ with all operations sharing a common mission of contributing to life and living for people around the world.

Company-Contact
Asahi Kasei Europe GmbH
Sebastian Schmidt
Am Seestern 4
40547 Düsseldorf
Phone: +49 (0)211 280 68 139
E-Mail: Sebastian.Schmidt@asahi-kasei.eu
Url: https://www.asahi-kasei.eu/

Press
financial relations GmbH
Henning Küll
Louisenstraße 97
61348 Bad Homburg
Phone: +49 (0) 6172 27159 12
E-Mail: h.kuell@financial-relations.de
Url: http://www.financial-relations.de