Groundbreaking research provides a promising potential alternative to manage devastating pandemic
SAN DIEGO, May 4, 2020 — Global Institute of Stem Cell Therapy and Research (GIOSTAR), the worldwide leader in stem cell research, is pleased to announce that they have received an approval for a COVID-19 clinical trial, led by their Medical Director Dr. Prabhat Soni. 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 two decades of stem cell research by GIOSTAR Co-Founder, Chairman and Chief Scientific Officer Dr. Anand Srivastava.
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 MSCs 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.”
GIOSTAR is a San Diego-based research institution headed by two visionary leaders. Dr. Anand Srivastava is the Institute’s Chairman and Chief Scientific Officer. Leveraging groundbreaking discoveries in gene therapy, he is an esteemed an illustrious scientific mind who pioneered the field of stem cell science more than two decades ago. CEO and President Mr. Deven Patel is a far-sighted, enthusiastic entrepreneur who collaborates closely with Dr. Srivastava to bring the GIOSTAR vision to reality each day.
Dr. Srivastava has authored several scientific publications in Journal of Stem Cell Research & Therapeutics, Current Pharmaceutical Design, and numerous other revered international scientific journals. These studies are the culmination of his work at University of California San Diego (UCSD), University of California Irvine (UCI), University of California Los Angeles (UCLA), The Salk Institute of Biological Studies, Sanford Burnham Prebys Medical Discovery Institute, and numerous other leading research institutions throughout the world. The Salk Institute was founded by Jonas Salk, the world-renowned scientist who developed the vaccine for polio.
GIOSTAR was formed with the vision to provide human stem-cell based therapy to aid those suffering from diverse degenerative and genetic diseases throughout the world. The Institute is the leader in developing cutting edge stem cell-based technologies, supported by leading scientists with the pioneering publications in the area of stem cell biology. GIOSTAR’s primary focus is to discover and develop cures for human diseases, with unique, state-of-the-art and stem cell-based therapies and derived products. Regenerative medicine provides promises for treatments of diseases previously regarded as incurable. GIOSTAR continually endeavors to develop affordable and accessible delivery systems globally for stem cell-based treatment.
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