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INDIAWEST NEWS – Indian American-founded GIOSTAR Announces FDA Approval for COVID-19 Clinical Trial with Stem Cells

Indian American-founded GIOSTAR Announces FDA Approval for COVID-19 Clinical Trial with Stem Cells copy

San Diego, California-based Global Institute of Stem Cell Therapy and Research, a leader in stem cell research, has announced that they have received an approval for a COVID-19 clinical trial, led by their Indian American 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 “expanded access for compassionate use” program, said a PRNewswire report. 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 Soni, the investigation is based upon two decades of stem cell research by GIOSTAR’s Indian American co-founder, chairman and chief scientific officer Dr. Anand Srivastava.

Dr Anand Srivastava & Dr Prabhat Soni

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, noted the report. 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, however, proven largely ineffective in managing the spread of the pandemic.

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 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, explained the report. 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.

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,” 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 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 leader in the field of stem cell research. Under the leadership of co-founders Srivastava and Deven Patel, the San Diego-based institute has a tradition of groundbreaking research in stem cell science spanning more than two decades, said the report.

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.

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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.

Related Links : http://www.giostar.com/

GIOSTAR in Process of US FDA Approval for Type 2 Diabetes Clinical Trial

Global Institute of Stem Cell Therapy and Research (GIOSTAR), the leader in regenerative technologies, is proud to announce that they are in the process of approval from the United States Food and Drug Administration (FDA) to conduct type 2 diabetes clinical trials focused on development of stem cell-based treatment. Led by GIOSTAR Chairman and Co-Founder Dr. Anand Srivastava, a team of scientists is further investigating a new potential approach to combat this disease, achieved through differentiation of stem cells into insulin-secreting cells.

Roughly one in 10 Americans suffers from diabetes, with nearly 200,000 cases impacting individuals under the age of 20. Several factors have contributed to this metabolic syndrome, including excessive consumption of high-calorie foods, an overly sedentary lifestyle, and other unhealthy habits. Given the staggering increase in the incidence of the disorder, the related cost of patient care has skyrocketed in recent years. A 2017 assessment by the American Association of Diabetes estimated the figure to be roughly $327 billion, which represents both direct medical costs and reduced productivity.

“The conventional approach to this epidemic,” noted Dr. Srivastava, “has primarily involved pharmaceutical products, which have several limitations.” GIOSTAR’s research into stem cells may provide an alternative that addresses these concerns. In contrast to the adverse side effects seen with these drugs, for instance, post-procedure symptoms of stem cell therapy are limited largely to mild fever, nausea, and headache. Furthermore, rather than simply “masking” the symptoms of diabetes, stem cells have the potential to provide a lasting cure.

More than 150 clinical trials listed on the National Institutes of Health (NIH) Website have revealed several potential benefits of stem cell implantation or infusion for the treatment of diabetes. Clinical parameters such as Hemoglobin A1c (HbA1c), for instance, decreased considerably after stem cell administration, as did the required amounts of insulin needed to manage blood glucose. Further, patients who received the treatments showed improved responsiveness to insulin. In most cases, patients continued to enjoy these benefits several months after follow up.

Dr. Srivastava’s studies focus on the therapeutic benefits of mesenchymal stem cells (MSCs). Isolated from visceral fatty tissues of adults, MSCs are known to improve pancreatic function, prevent cell death, decrease systemic oxidative stress, and reduce insulin resistance through the secretion of paracrine factors. Additionally, after exposure to interferon gamma (IFN-γ) and other pro-inflammatory cytokines, MSCs may become a source of anti-inflammatory cytokines which may generate new insulin-producing cells. Finally, intravenous infusion of stem cells has been shown to regenerate beta cells of pancreatic islets and promote insulin sensitivity by decreasing systemic inflammation – the root cause of insulin resistance.

“Stem cell therapy may offer a long-lasting therapeutic alternative for treating type 2 diabetes,” concluded Dr. Srivastava. “However, additional research is needed, and we must remember that this is not a permanent cure yet.”

About GIOSTAR

GIOSTAR is the pioneer and established leader in the field of regenerative medicine. Under Dr. Srivastava’s leadership, the San Diego-based Institute has a tradition of groundbreaking research in the field of stem cell science spanning more than two decades.

News Source : https://bit.ly/3f8b5Lg

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