GIOSTAR Announces FDA Approval Under Compassionate Use for a COVID-19 Clinical Trial with Stem Cells

The COVID-19 pandemic has resulted in unprecedented disruption, with more than 3 million cases and 200,000 deaths reported worldwide as of May 1, 2020 – a figure that is projected to grow exponentially in the weeks ahead. Caused by a pathogenic virus known as SARS-CoV-2, the infection induces a broad range of responses in humans: some patients are asymptomatic, others develop mild flu-like discomfort, and still others suffer from severe pneumonia. Physicians have resorted to numerous traditional and unconventional therapies to combat the effects of COVID-19. These therapies – which include antibiotics and plasma therapy – have proven largely ineffective in managing the spread of the pandemic.

A Novel Approach to Inflammation
Given these challenges, there has unsurprisingly been a surge in clinical trials for use of MSC’s to combat COVID-19. Cedars-Sinai Medical Center recently cited studies that “support the notion that cell therapy can attenuate inflammation, which may be attractive in COVID-19.” One study by an international coalition of researchers from China, United States, India, France, and other countries appeared in Aging and Disease, showing full recovery of seven COVID-19 patients 2 weeks after receiving intravenous (IV) administration of allogeneic (sourced externally from donors) MSCs.

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 extensive 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.”

Seeing great potential in this therapeutic approach, the FDA approved MSC-based treatment for use in the most severe cases of COVID-19, under their “expanded access for compassionate use” program. 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.

“GIOSTAR appreciates the FDA for their timely action in approving the protocol,” noted Dr. Soni. “We’re looking forward to sharing the findings from our studies with the world, which may help save many lives in the future.”

About GIOSTAR
GIOSTAR is the pioneer and established leader in the field of stem cell research. Under the leadership of Co-Founders Dr. Anand Srivastava and Deven Patel, the San Diego-based Institute has a tradition of groundbreaking research in stem cell science spanning more than two decades.