For the elderly and the infirm getting a corona virus COVID-19 diagnosis is like a death sentence. As the world sits at home with baited breath waiting for herd immunity or a vaccination, an Israeli company called Pluristem might have the cure. In a fast-tracked clinical trial running in Israel 100% of critically ill patients (a group of 7) survived Covid-19, while more than half improved and are now weaning off of ventilators.
The Israeli medical company Pluristem Therapeutics (Nasdaq:PSTI) founded in 2001, has announced that its stem cell therapy treatment, using placental stem cells, has been successful in its preliminary trials on patients who are severely ill with coronavirus.
The trials were able to proceed quickly based on fast-tracking laws in cases of compassionate use. The Pluristem’s stem cell treatment called PLX was applied to critically ill people facing organ failure. The company already has a drug in the pipeline to treat radiation sickness and has worked with NASA to solve long duration space travel.
In the trial in Israel, Pluristem’s placental expanded cells (called PLX) were able to scale back a severely overactive immune system response that causes pneumonia and untimely death by COVID-19. The company’s treatment stimulates the body to regenerate its own cells. While the study is young and the PLX treatment was used on only 7 patients who were suffering from Acute Respiratory Distress Syndrome, the future looks very bright for the company and for us.
The company plans on starting clinical trials in the United States and Europe as soon as regulatory hurdles allow them to do so.
There have been about 10,000 confirmed cases of COVID-19 in Israel, with about 120 deaths. Pluristem was able to apply their novel drug treatment in three medical centers in Israel. Among the patients four demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and an overall very poor prognosis.
“Pluristem is dedicated to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients in significant need,” said Yaky Yanay, Pluristem’s CEO and President.
All the treated patients were considered high risk for mortality yet 100% managed to live, according to the company. Two patients with multi-organ failure prior to treatment, showed clinical recovery in addition to the respiratory improvement.
As a next step, the company plans to apply for initiation of a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19. In this regard, while Pluristem expects to continue treating patients for complications associated with COVID-19 under the compassionate use program in Israel.
PLX Cells for Covid-19 can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic. The stem cells are not culled from a live source or a patient’s own cells, but are cells grown on a 3D scaffold in the lab. The drug can be given to patients without the long and complicated process of tissue matching.
Israel is years ahead of the United States on stem cell therapies as it was pretty much an unfundable enterprise in the United States, starting with a bill that was passed in the US in 2009.
While stem cell research was never illegal in the United States, the funding-barring mechanism put into place in 2009 by Christian law that equates placental stem cell research as a sin seriously damaged any advances in that field.
Israel, as a Jewish state, does have restrictions and ethical guidelines in place, and its halachic or Torah-based laws do rule research directions. Jewish law, supported by leading rabbis believes that life in utero does not start at conception, but only at 40 days after conception. So early stage embryonic tissue may be used as a research base.
Stem cell research in Israel has not faced the same hurdles as in the US or Europe. It is recognized as potential cures and therapies in cancer, replacing or fixing damaged organs, such as in spinal cord injury, or pneumonia. Or in novel areas that mitigate animal suffering and climate change such as cultivating lab grown meat.
Israel leads the way in stem cell research over the United States and Europe per published paper, per capita.
A vaccine and a cure?
PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. The company has used their treatment to help a number of medical problems including radiation poisoning.
Yanay notes that the PLX cells may potentially reduce the incidence and severity of covid-19 pneumonia and pneumonitis leading to a better prognosis for the patients. This isn’t new science for the company: pre-clinical findings of PLX cells in previous animal studies shows that the treatment helps pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are complications of the severe COVID-19 infection.
The company hopes that with clinical trials from hundreds of patients globally they can slow, maybe even stop the devastating damage of COVID-19.
Key highlights for those able to help fasttrack regulatory approvals:
- All treated patients were in Intensive Care Units (ICU) on ventilators and suffered from Acute Respiratory Distress Syndrome (ARDS)
- 100% survival rate for all seven patients
- 6 patients completed 1 week follow up; the seventh patient was treated on April 5 2020
- 4 of the 6 (66%) patients that completed 1 week follow up demonstrated improvement in respiratory parameters
- 3 of the 6 (50%) patients that completed 1 week follow up are in advanced stages of weaning from ventilators