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The bioreactor where Pluristem produces cells for its treatment (David Garb)

‘I think this will have a huge impact,’ CEO of Pluristem says, but public health expert cautions: ‘I don’t have any feeling this is going to work’
Israeli scientists who claim a single placenta can treat 20,000 coronavirus sufferers are hopeful after beginning the treatment, as some of its first patients have shown improvement while their company’s shares have skyrocketed.
Pluristem Therapeutics uses placentas to grow smart cells, and programs them to secrete therapeutic proteins in the bodies of sick people. It has just treated its first American COVID-19 patient after treating seven Israelis.
There is no follow-up data on the American patient, but the company reported that as of a follow-up on April 7, all seven Israelis had survived and three were on target to soon move off ventilators, while one had shown deterioration in respiratory parameters
Two of the four Israelis with multiple organ failure showed clinical recovery as well as respiratory improvement. All patients were one week after treatment at time of follow-up, apart from one, who received treatment after the others and whose health update wasn’t reported.
The treatment of select patients doesn’t constitute a clinical trial and there is no control group, but company CEO and president Yaky Yanay said Thursday that a trial will come soon and, once conducted, he hopes that “approval can be very fast.” Upon receiving the green light from regulators, he said, massive quantities of treatment can be prepared. “We can manufacture cells to treat thousands very quickly,” he said.
The market appears to share his optimism. For most of 2020 shares have traded at under $4; now the price is close to $10.
But public health expert Manfred Green said he is “very very cautious” about such innovations. Green, founding director of the Israel Center for Disease Control and director of the University of Haifa’s international masters program in public health, said: “I don’t have any feeling this is going to work. This is a viral disease, not something from outer space, and for viral diseases we’ve always struggled to find treatment.”
Yanay said that his innovation will save lives, both by improving the health of critical patients, and by freeing up space in intensive care units for others.
I think this will have a huge impact because currently the battle is in the ICUs,” he said. “We need to take people off ventilation machines and get them out of ICUs.”
The treatment is waiting on regulatory approval, but Pluristem is receiving approvals on a patient-by-patient basis in Israel and the US, hoping to gather enough information for full approval. In Israel it has worked so far at three hospitals under a compassionate use program, and at Holy Name Medical Center in New Jersey it was allowed to administer cells under the Coronavirus Treatment Acceleration Program, an emergency mechanism for possible therapies.
Treatment consists of 15-milliliter doses of cells — known as PLacental eXpanded cells — administered in simple inter-muscular injections. Once in the body, Yanay said that the cells become like “a small factory that generates therapeutic proteins.”
He explained: “Most drugs we know are administered in the quantity we need, but this is a ‘drug’ that can sense the human body’s environment, and based on the signals that the cells receive from the body, they secrete therapeutic proteins that push the body toward regeneration.”
The cells secrete two types of proteins. One reduces inflammation; the other is to regulate the immune system. Yanay hopes these so-called immunomodulation proteins can slam the brakes on the immune system to stop it turning on itself, as commonly happens with critical coronavirus patients.

                      Yaky Yanay (David Garb)
“They stop the body from attacking its own organs by having the placenta cells secrete immunomodulatory factors, basically relaxing the immune system, as the other proteins reduce inflammation,” said Yanay.
He elaborated: “Patients who are in severe condition and dying are actually dying from a severe respiratory condition. What is actually happening is there is a very high level of inflammation and at a certain point the immune system of the patient will attack [the patient], mostly in the lungs.”
Until now, Pluristem’s technology has been largely used to treat people suffering from poor blood flow to the legs, but the company’s scientists were able to quickly repurpose the cells to treat coronavirus patients.
“We take cells from the placenta after full-term delivery and we have developed technology to expand the cells to very large numbers, in an environment that mimics the human body,” Yanay said. “The technology allows us to treat more than 20,000 people from a single placenta.”
His team “programs” the cells, which then have a wide range of proteins they can secrete. The cells don’t just deliver the proteins but also “adjust the level of secretion based on signals they receive from the body,” he said.
Yanay stated that Pluristem, which is based in Haifa, will carry on treating people using patient-by-patient approvals, while working as quickly as possible for full approval by regulators.
“We are receiving many inquiries and requests for treatment from health care providers and families worldwide,” he said. “In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries.
“Our main focus remains, however, the initiation of a multinational clinical study,” he said, adding that he was hopeful “cell therapy is a very good candidate to tackle a complex disease that is attacking several organs.”
Times of Israel News

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