La Jolla native seeks speedy FDA approval for COVID-19 stem cell treatment
La Jolla native Dr. Bob Harman is applying his expertise in the veterinary and biotech fields to developing a stem cell treatment for COVID-19.
As chief executive of Personalized Stem Cells Inc. in Poway, Harman is involved in the company’s quest to have the U.S. Food and Drug Administration fast-track its investigational new drug application for the treatment of COVID-19 patients with stem cells.
Personalized Stem Cells’ parent, VetStem Biopharma, has provided stem cells for treatment of more than 15,000 dogs and horses and for treatment of animals at the San Diego Zoo, Safari Park and SeaWorld.
Personalized Stem Cells has provided stem cells for an FDA-approved human clinical trial for treatment of knee arthritis. Future stem cell clinical trials are planned for back pain, traumatic brain injury and opioid addiction.
Harman’s own work with stem cells dates to the 2007 Witch Creek fire when two of his horses were caught in a burning horse trailer in Ramona. The horses suffered severe smoke inhalation, but after Harman treated them with stem cells, there were no signs of lung damage, he said.
Fast-forward 13 years and Harman sees the same possibilities to repair damaged lungs in COVID-19 patients using stem cells. Harman said the FDA is reviewing the investigational drug application for its stem cell therapy in COVID-19 patients.
At the encouragement of the White House Coronavirus Task Force, Personalized Stem Cells has applied to the FDA’s Coronavirus Therapeutic Accelerator Program, which could expedite clinical trials.
If the FDA approves the application, which Harman foresees as imminent, Personalized Stem Cells would initiate a clinical trial to test the effectiveness of stem cells in COVID-19 patients.
Harman anticipates the first 20 patients in the CoronaStem 1 trial could be treated by early next week at Sharp Grossmont Hospital in La Mesa, pending approvals.
Personalized Stem Cells also plans to ask the FDA to allow “compassionate use” of the stem cell treatment, which Harman said would provide early and widespread access to the treatment without clinical trials.
“Here at Poway, we can make doses to treat 10,000 patients each month if approved by the FDA,” said Harman,
who was born in La Jolla and attended Torrey Pines Elementary, Muirlands Middle and La Jolla High schools. He currently lives in Ramona.
Harman said other companies developing similar but different stem cell treatments in Australia, China and Israel have demonstrated “striking results” in COVID-19 patients in intensive care units. He said stem cells have been injected intravenously to allow the stem cells to enter the lungs, where they help reduce inflammation and damage to the patients’ lungs. Harman cites a 50 percent to 90 percent reduction rate in patient deaths related to COVID-19 in those countries.
Ventilators are not the solution to treating patients, he said, because as many as 90 percent of COVID-19 patients die while connected to ventilators.
“Everybody talks about the need to manufacture ventilators,” he said. “That’s a last-ditch effort. Once you’re on a mechanical ventilator, it’s bad news. I’ve never seen anything as dramatic as the possibilities for using stem cells to treat COVID-19.”
The treatment that Personalized Stem Cells is developing also potentially could be used to treat influenza patients and those affected by other virus outbreaks in the future, he said.
Personalized Stem Cells’ method of growing stem cells starts by collecting cells from adult fat tissue. Harman said donors supply the cells through liposuction procedures. The cells are tested to ensure they are disease-free and are then grown in sterile rooms. He said the cells will multiply, creating a large volume of stem cells that are packaged and frozen so they can be stored for up to 20 years.
If and when the CoronaStem 1 trial is completed, which Harman estimated could be within 90 days, the company would apply to the FDA to conduct a larger CoronaStem 2 trial possibly involving other hospitals in California.
Depending on how well the stem cells perform in the first phase of the study, the FDA also could approve widespread distribution of Personalized Stem Cells’ treatment.
Harman said there may be a downward trend in COVID-19’s spread by early summer, but he expects it will continue to linger.
“The prediction that by summer this will be on a downturn is very real as long as we keep up appropriate safety measures,” he said. “I think we will see that by early summer it will slow down, but it won’t be gone. It’s not just going to disappear. It doesn’t go away easily.”
Personalized Stem Cells and VetStem Biopharma, which have 31 employees combined, are pursuing grants and donations to prepare for ramped-up production of stem cells. Calidi Biotherapeutics is collaborating with Personalized Stem Cells to provide needed cell lines and supplies to speed stem cell manufacturing.
But money also is needed to pay the doctors, nurses, imaging technicians, laboratories and others involved in performing the medical procedures for the clinical trial. In addition to seeking government grants, Personalized Stem Cells is reaching out to philanthropic groups such as the Gates Foundation and partnering with the nonprofit San Diego Foundation to accept donations.
“Everyone wants to help, and this is something very tangible that you can do,” Harman said. “We are raising additional capital to be able to provide stem cell therapy to a wider population and potentially to underserved groups.”
For more information, visit personalizedstemcells.com/covid-19. ◆
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