Pluristem expects to treat more patients in Israel in the coming days * Discussions are underway between the company and regulators in the US and Europe in order to define the company's clinical strategy regarding COVID-19
Pluristem, which develops a platform for biological medicines, announced today that since its last update on the subject of COVID-19, three patients in two different hospitals received its medicine as part of a program for compassionate treatment of COVID-19, and in accordance with the approval of the Ministry of Health. Pluristem expects to recruit more patients in Israel in the coming days and is expected to provide updates regarding clinical results when it has significant data.
All three treated patients are in a high risk group according to their age and existing underlying diseases. The patients experienced severe respiratory failure, underwent intubation and were connected to artificial respiration. Pluristem closely monitors the clinical condition of these patients, together with the medical staff of the hospitals providing the treatment. To meet the expected demand, Pluristem is ready for a significant increase in the production of PLX cells, while maintaining a consistent quality in the production of the cells. Production is done at the company's facilities in Haifa, which have GMP certification.
CEO and President of Pluristem, Yaki Yanai said that "during this emergency, we have the honor to participate in the global effort to support patients and health systems. We are full of admiration for the tireless efforts of the medical teams in the hospitals, and we would like to thank them for their cooperation and support. We hope that our shared ambition to help patients will lead to good results among patients experiencing life-threatening complications as a result of COVID‑19. In addition to our current activity in Israel, discussions are underway between the company and regulators in the US and Europe to define the company's clinical strategy on the subject of COVID-19. Pluristem's advanced manufacturing capabilities allow us to meet the potential need to treat a large number of patients, as part of compassionate care and clinical studies, in a large number of countries and hospitals, in accordance with the expansion of our program and regulatory approvals. We are now facing a very different global situation, and the entire Pluristem team is fully committed to being an important part of the solution."
PLX cells for the treatment of COVID-19
The availability of PLX cells as an 'off the shelf' product, and as a product that, once marketed, the company has the ability to produce in large quantities, are important advantages in dealing with a global epidemic. PLX cells are allogeneic mesenchymal-like cells that have a regulatory effect on the immune system, by encouraging the creation of inflammation-regulating cells in the natural immune system, including regulatory T cells and M2 macrophages, and thus may prevent or reduce the dangerous overstimulation of the immune system that occurs in some corona patients . In this mechanism, PLX cells may reduce the incidence and/or severity of pneumonia and pneumonitis and thus hopefully lead to a better prognosis for patients. Findings from preclinical studies with PLX cells have shown therapeutic efficacy in models of hypertension and pulmonary fibrosis as well as in models of acute kidney injury and gastrointestinal injury that are possible complications of COVID-19 infection. Findings from clinical trials with PLX cells demonstrated the abilities of PLX cells to modulate the immune system response in patients after major surgery. Based on the potential capabilities of PLX cells and the safety profile of the cells gathered from clinical studies involving hundreds of patients worldwide, PLX cell therapy may be a potential treatment to reduce the damaging effects of COVID-19 on tissues.
The therapeutic effects of Pluristem's PLX cells in the treatment of respiratory and inflammatory complications related to COVID-19 are being studied within the framework of Pluristem's cooperation agreement with the BIH Center for Rehabilitation Therapy (BCRT) and the Berlin Center for Advanced Treatments (BeCAT) at the Charita University of Medicine in Berlin.
More of the topic in Hayadan:
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It's very exciting, I hope they will recover, all the best for the donation and compassion
I have a question. I have had a stroke. Can an injection of stem cells help me? Thanks in advance
Who will be experimented on? Only on patients.
...an experiment that will succeed or not and bring money to the developers (or not) is indeed compassion.... Using a proven but expensive drug I would still get this PR - but this case is just an experiment on patients.
Really "compassionate treatment" is all an experiment that will succeed or not. A little less hypocrisy wouldn't hurt this site.