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First Patients Treated in COVID-19 Stem Cell Clinical Trial
Feb 19, 2021
In 2020, Personalized Stem Cells developed and secured FDA approval for a COVID-19 stem cell clinical trial. In October of last year, we announced that we out-licensed our allogeneic stem cell program, including the COVID-19 therapy, to Sorrento Therapeutics. Recently, Sorrento announced that the first clinical trial participants received stem cell therapy for COVID-19.
Stem Cell Therapy for COVID-19
Infection with COVID-19 can lead to Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious lung condition that is typically characterized by an acute inflammatory response which leads to fluid buildup in the lungs and ultimately low blood oxygen levels. ARDS may lead to long term complications or death.
When administered intravenously, mesenchymal stem cells (MSCs) travel to the lungs. MSCs have demonstrated the ability to down regulate inflammation and inhibit lung fibrosis (scar tissue). Additionally, MSCs have been shown to aid in clearing fluid from the lungs and may lead to lung tissue regeneration. These, among other mechanisms of action, make stem cell therapy a potentially viable treatment option for the serious lung complications that can result from infection with COVID-19.
For more information about stem cell therapy for COVID-19, read a literature review published by PSC doctors and collaborating scientists discussing "the rationale behind using stem cells to treat patients with COVID-19".
COVID-19 Stem Cell Clinical Trial
Patients participating in the COVID-19 clinical trial will receive one injection of stem cells every other day for a total of three injections. The stem cell treatments, termed COVI-MSC™ by Sorrento, are administered intravenously. According to Sorrento’s recent announcement, four patients have completed the stem cell treatments and all four have been discharged from the hospital.*
According to Sorento, there have been no infusion related adverse events reported in any of the patients. As a phase 1b study, the primary objective of the clinical trial is to focus on the safety of the stem cell treatments. While the preliminary safety data looks promising, the preliminary efficacy data looks equally as promising.1
* now 9 of 9 released from ICU and hospital a few days after treatment.
1 "At the request of the White House Coronavirus Task Force, PSC submitted an Investigational New Drug (IND) application to the FDA in April 2020 and received approval in July 2020. PSC, which primarily focuses on orthopedics, went on to grant global rights to its adipose-derived allogeneic mesenchymal stem cell (MSC) program, including the COVID-19 therapy candidate, to Sorrento Therapeutics in October 2020.
As discussed in a peer-reviewed scientific article published by PSC and collaborating scientists on the rationale behind using stem cells to treat COVID-19, MSCs have demonstrated the capacity to inhibit lung damage, reduce inflammation, dampen immune responses and aid with alveolar fluid clearance. Additionally, MSCs produce molecules that are antimicrobial and reduce pain. Recently, the application of MSCs in the context of ongoing COVID-19 disease and other viral respiratory illnesses has demonstrated reduced patient mortality and, in some cases, improved long-term pulmonary function."
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