ImmunoArt, a break-through new cell therapy developed by Educell has proven successful in reducing inflammation of the lung tissue and addressing ARDS (Acute Respiratory Distress Syndrome) appearing in terminal stage COVID-19 patients in Italy and Serbia
Ljubljana, Slovenia April 15, 2020
The final stage of Coronavirus Disease 2019 – COVID-19 is a patient in ICU struggling to breathe with the help of a ventilator, however this is only a coping mechanism, an attempt to keep the patient alive. The real problem for critically ill patients with COVID-19 is an acute inflammation of the lung tissue, called Acute Respiratory Distress Syndrome (ARDS), which causes that not enough oxygen enters the blood circulation, finally leading to death in 50% of cases.
Today there is no effective clinically tested and approved drug or treatment for ARDS. However, scientists have been exploring the use of mesenchymal stromal/stem cells (MSCs) for over a decade (, , ). MSCs have been proven as anti-inflamatory and have been shown to alleviate ARDS, even in Wuhan China during the first wave of the spread of COVID-19 in January (). All over the world, many clinical studies employing MSCs for the treatment COVID-19 respiratory complications are ready to begin.
Dr Miomir Knežević with the team at Educell, Slovenia, who have been working with MSCs for 23 years, have developed ImmunoArt cell therapy, a technology for preparing potent immunomodulatory MSCs. Now three patients are undergoing treatment with MSC cells and 10 new samples will be prepared weekly to treat even more in two medical centers in Italy and Serbia. Clinical leaders in both countries applied to their corresponding medical ethical committees for compassionate use of this new treatment, and both have received approval for cell therapy use, leading into an approved clinical study on 30 patients.
Dr Knežević estimates that MSCs can reduce fatality of ARDS from 50% to below 20%. Educell along with a consortium called Fight Against Corona! (FAC!) are now entering into the clinical study to prove effectiveness and safety of MSCs. Educell is working together with the FAC! consortium, physicians, medicines agencies and investors in order to scale the production of ImmunoArt cell therapy. ImmunoArt cell therapy is Educell’s proprietary technology of preparing MSCs, of appropriate characteristics and in sufficient quantities of cells, to be administered systemically into the patient’s bloodstream.
To prepare stromal/stem cell therapy product, first cells have to be isolated from various tissues, for example: bone marrow, belly fat (lipoaspirate), umbilical cord tissue. Isolated cells are then selected and multiplied in bioreactors, following detailed protocols. One bioreactor, a device in use in many biotechnology labs, can produce up to 10 doses of ImmunoArt cells in a week, ready to help 10 patients.
In order to help in the current crisis, Educell is prepared to share its ImmunoArt method with qualified partners first, to enable enough production of cells to support clinical studies and second, to produce cell for the application to all patients in need and all the physicians willing to use the therapy.
Even without COVID-19, there are reported 200.000 cases of ARDS annually in USA alone. ARDS incidence from COVID-19 at this moment is estimated at 50.000 and growing steeply. If MSCs prove as promising in the next stages of clinical trials and are allowed to be broadly applied in the future, it will not only save lives, but also help many patients who would/could survive on their own and leave ventilation in over-burdened ICU units much sooner, providing much needed relief to medical staff. And that is another potential upside.
Partners, investors and collaborators are invited to write to us at firstname.lastname@example.org.
Video statement by Dr Miomir Knežević is available on THIS LINK.
On-line press organized by STA – Slovenian Press Agency will be broadcasted on Thursday 16 April 2020 at 1pm (CET). Please follow press event on STA YOU TUBE CHANNEL.
For more information:
Press relations: Investor relations:
Jadranka Jezeršek Turnes Dr Miomir Kneževič
+386 30 300 620 +386 41 707 937
Educell Ltd, established 1997, is a company focusing on development of cell therapy products and is a registered Cell and tissue establishment. The company is preparing cell therapy products for the treatment of articular cartilage, vesicouretral reflux, regeneration of bone tissue and treatment of immunological disorders, which are all being used in University Medical Centre Ljubljana and other clinical institutions in Slovenia under “hospital exemption” rule supervised by Agency for Medicinal Products and Medical Devices of the Republic of Slovenia. R&D department is dedicated to development of innovative cell therapy products and also to development of medical devices that enable stem cell isolation and application in the operation theatre.
ImmunoArt cell therapy product was developed in 2014 and is based on ex vivo expanded allogeneic mesenchymal stromal/stem cells (MSC) isolated from bone marrow. Its immunomodulatory capacity has already been proven in the clinics for the treatment of graft versus host disease (GvHD) and Chron’s disease.
About dr.Miomir Knežević, CEO of Educell
CEO of Educell; PhD in Biotechnology; During his more-than-30-year professional career he co-founded several biotech companies, with participation of Venture capital. He worked as a national expert on detachment in the unit for Applied Genomics, Biotechnology for Health, in the directorate Health, DG Research, European Commission, Brussels and he had a position at the Blood Transfusion Centre in Ljubljana as the Head of the Unit for Collection and Processing of Haematopoietic Stem Cells. He collaborated as an Assistant Director for Technology Transfer with the National Institute of Biology research project where he coordinated international project SYSTHER. He has co-authored 286 publications, including 22 original articles in scientific journals.
About FAC! Consortium
FAC! Consortium was formed in order to apply to a Horizon 2020. The consortium partners, many of which have been long-time partners in biotechnology, medicine and research, will cooperate with the aim to develop several novel treatments. The consortium is composed of 13 partners from 3 continents and 8 countries and includes members with expertise in cell therapy, bioreactor and medical device engineering, virus identification and characterization, biopharmaceutical manufacturing, critical care and clinical trial management, and regulatory affairs. Fight Against Corona! Consortium consists of: Educell (Slovenia), lead partner, Azienda Sanitaria Universitaria Friuli Centrale (Italy), Celonic (Switzerland), Conreso (Germany), Nantkwest (USA), Nantworks (USA), National Institute of Biology (Slovenia), Omega (Slovenia), Orgenesis (Israel), Stempeutics (India), Team Consulting (UK), University Ljubljana (Slovenia), and Vivabiocell (Italy).
Safe harbour statement
Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Educell’s preclinical and clinical studies, and Educell’s research and development programs; Educell’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Educell’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Educell’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Educell’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Educell’s ability to enter into and maintain established strategic collaborations; Educell’s ability to establish and maintain intellectual property on its product candidates and Educell’s ability to successfully defend these in cases of alleged infringement; the scope of protection Educell is able to establish and maintain for intellectual property rights.
You should read this press release together with our risk factors or on our website. Uncertainties and risks that may cause Educell’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
1)Lopes-Pacheco M et al. Current understanding of the therapeutic benefits of mesenchymal stem cells in acute respiratory distress syndrome. Cell Biol Toxicol. 2020 Feb;36(1):83-102. doi: 10.1007/s10565-019-09493-5. Epub 2019 Sep 4.
2) Cruz FF, Rocco PRM. Cell therapy for acute respiratory distress syndrome patients: the START study. J Thorac Dis. 2019 May;11(Suppl 9):S1329-S1332. doi: 10.21037/jtd.2019.04.22.
3) Matthay MA et al. Treatment with allogeneic mesenchymal stromal cells for moderate to severe acute respiratory distress syndrome (START study): a randomised phase 2a safety trial. Lancet Respir Med. 2019 Feb;7(2):154-162. doi: 10.1016/S22132600(18)30418-1. Epub 2018 Nov 16.
4) Leng et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging and disease 2020, Vol. 11 Issue (2) : 216-228 DOI: 10.14336/AD.2020.0228, April 2020
 Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA 2016;315:788-800.