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FDA Grants ‘Compassionate Use’ Approval to COVID-19/Stem Cells Clinical Trial

SAN DIEGO, CA (US), May 2020 — Global Institute of Stem Cell Therapy and Research (GIOSTAR) has received approval for a COVID-19 clinical trial, led by medical director Prabhat Soni, M.D. GIOSTAR will conduct the trial using stem cells to treat COVID-19 patients, under the approval of the United States Food and Drug Administration (FDA) "expanded access for compassionate use" program.

The institute is exploring a promising alternative approach to the devastating disorder, which leverages the anti-inflammatory properties of mesenchymal stem cells (MSCs). According to Dr. Soni, the investigation is based upon stem cell research by GIOSTAR co-founder, chairman and chief scientific officer Anand Srivastava, M.D.

COVID-19 is induced by a release of signaling molecules known as cytokines — small protein molecules released by immune cells to orchestrate the "attack-and-destroy" mode of the host's immune system response to pathogens. Cytokines are either proinflammatory ("bad") or anti-inflammatory ("good"), meaning that they either increase or decrease levels of inflammation in the body. In the case of COVID-19, an uncontrolled immune response leads to a "cytokine storm," dramatically raising levels of IL-6, IL-8, and TNF-alpha and other proinflammatory proteins. The immune system then goes into overdrive mode, thereby causing potentially fatal damage to the patient's own tissues and organs. 

Drs. Srivastava and Soni sought to leverage and apply research demonstrating the effectiveness of MSCs in combating the respiratory symptoms and cytokine storms associated with COVID-19. "The cells have specific characteristics that, when infused in the bloodstream," Dr. Srivastava explained in an educational video, "neutralize the proinflammatory cytokines, down-regulate the inflammatory gene actions (through 'immunomodulation') and send messages to regenerate damaged lung tissues." 

The first patients will be treated in New York City. The city has been among the most severely impacted regions of the country, with more than 170,000 confirmed cases of COVID-19 and 13,000 deaths as of May 1, 2020. 

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