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Re: dia76ca post# 9759

Saturday, 04/24/2021 11:01:34 AM

Saturday, April 24, 2021 11:01:34 AM

Post# of 14947
Regarding stem cell availability Paul replied...
"PSC can manufacture up to 8,000 stem cell treatments(Covi-MSC) for patients per month as per Dr. Harman back on April 13, 2020. I read somewhere else they have been stock piling them so they have a large supply by now. My thought is EUA in May or June latest. Overall I like the Reddit post.

PSC was asked by the White House Task Force to apply to the FDA for expedited review of their IND application for treating COVID-19 patients with stem cells. PSC submitted its emergency assistance application to the FDA March 30th and its formal IND submission this week. PSC has FDA-inspected stem cell manufacturing facilities that are already in production of stem cell doses for clinical trials and compassionate use.
“Stem cell doses can be released for clinical trial use in May, depending on FDA clinical trial approval,” said Dr. Bob Harman, CEO of PSC. The first trial will be conducted in San Diego, California in a limited number of patients hospitalized locally, but compassionate use could allow for many more patients to be treated.
Calidi Biotherapeutics is a San Diego oncology company that provided the stem cell lines to PSC, giving PSC a running start in the stem cell drug manufacturing process. “We are proud to have provided these pre-tested stem cell lines for PSC to accelerate their manufacturing to provide stem cells to patients afflicted with COVID-19,” said Calidi CEO Allan Camaisa. “We have a long-standing relationship with Calidi and were already in the manufacturing process since January with these disease-screened stem cell lines. Calidi’s generosity and collaboration saved us valuable weeks in this race to get stem cells into clinical trials,” says Dr. Harman.
After this initial FDA trial is started, PSC will apply to FDA for a wider compassionate use approval and could also ship cells internationally. PSC is already ramping its manufacturing but is constrained by capital for critical supplies used in making these cells. “With adequate capital (investors or philanthropy), we could manufacture stem cell treatments for up to 8,000 patients per month,” said Dr. Harman.
PSC is an essential services company and is running at full speed. “Our team is following our very rigorous personal protection program to keep our employees safe, while executing the mission with amazing passion to bring these stem cells to critical patients. I am humbled every day and work all the harder to support our team in this mission. As always, small business is ready to shoulder any task. This is a war and we are using every resource possible to support the front-line doctors trying to save patients’ lives every day. We are even hiring new stem cell manufacturing technicians, doing our part to keep the economy running,” says Dr. Harman.

https://personalizedstemcells.com/covid-19-emergency-stem-cell-treatment-collaboration-in-san-diego/

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