GIOSTAR Announces FDA Approval Under Compassionate Use for a COVID-19 with Stem Cells
GIOSTAR Received FDA Approval Under Expanded Access For Use of Stem Cells to Treat COVID-19 Patients
Under expanded access, also known as compassionate use, the U.S. Food and Drug Administration (FDA) has approved GIOSTAR the emergency use of stem cell therapy to treat acute inflammation of the lungs in hospitalized patients diagnosed with COVID-19. Expanded access allows patients to receive stem cell therapy on a case-by-case basis outside of a conventional clinical trial as deemed appropriate by the treating physician, the GIOSTAR medical director and the FDA. Each patient will be assessed to determine if stem cell therapy is appropriate and a separate Investigational New Drug (IND) application will be filed for the FDA’s approval every single time. Patients will be evaluated after the infusion of the stem cells and the outcome of the treatment will be submitted to the FDA regularly.
Treatment of COVID-19 patients with mesenchymal stem cells (MSCs) has been shown to be beneficial in a number of studies from USA, Israel, China and UAE[Admin1] . In the U.S., the FDA approved a clinical trial to study use of umbilical cord stem cells in the treatment of COVID-19 patients https://newsroom.baptisthealth.net/press-release/fda-approves-covid-19-trial-after-successful-emergency-use-of-umbilical-stem-cells-from-restem/
COVID-19 infection causes an acute flow of inflammatory cytokines like IL-6, GCSF, IP10, MCP-1, MIP1A, and TNF-α in the lungs, which cause and promote formation of microthrombi. These microthrombi can block normal flow of blood in any part of the body leading to pathogenesis in the afflicted organ. This could be a very probable reason as COVID-19 has been shown to affect any part of the body like brain, heart, kidneys, intestines and of course the lungs.
The MSCs, known for its immunomodulatory character and secret a lot of anti-inflammatory cytokines and suppress the pro-inflammatory cytokines. After infusion in COVID-19 patients, MSCs have been shown to have high expression of anti-inflammatory and trophic factor genes like HGF, LIF, NOA1, VEGF, EGF, BNDF and NGF to name a few. These anti-inflammatory cytokines may help alleviate the COVID-19 symptoms. Transplantation of ACE2-Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia Aging and disease (2020) 11: 216-228;Cytokine release syndrome in severe COVID-19 Science (2020) 368-473-474
Groundbreaking research provides a promising potential alternative to devastating pandemic
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 COVID-19 clinical trial, led by their Medical Director Dr. Prabhat Soni. GIOSTAR will conduct the trials 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 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.
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