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

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/

https://www.prnewswire.com/news-releases/giostar-announces-fda-approval-under-compassionate-use-for-a-covid-19-clinical-trial-with-stem-cells-301051830.html

GIOSTAR Reports on a Positive Outcome of a COVID-19 Patient After Stem Cell Treatment

GIOSTAR Reports on a Positive Outcome of a COVID-19 Patient After Stem Cell Treatment

Promising results point to a potential alternative in combating the pandemic

SAN DIEGO, July 21, 2020 /PRNewswire/ — Global Institute of Stem Cell Therapy and Research (GIOSTAR), the worldwide leader in stem cell research, is pleased to announce the outcome of a COVID-19 patient treated using stem cells. Led by Chairman and Co-Founder Dr. Anand Srivastava, GIOSTAR received approval for the treatment under the U.S. Food and Drug Administration (FDA) “expanded access for compassionate use” program. As of July 14, 2020, there have been more than 13 million COVID-19 cases and over 500,000 deaths worldwide.

Contending with a Grim Prognosis

Under the direction of GIOSTAR Medical Director Dr. Prabhat Soni, a 53-year old male patient suffering from COVID-19 pneumonia was admitted to Saint Michael’s Medical Center in Newark, New Jersey, under the care of Dr. Richard Miller, MD, Chairman, Department of Pulmonary Medicine. The patient’s condition worsened over the course of the standard treatments, along with convalescent plasma therapy. He went into septic shock and his renal and hepatic functions continued to decline, requiring dialysis. The patient suffered a stroke, and remained in a coma at Saint Michael’s intensive care unit (ICU).

GIOSTAR Reports on a Positive Outcome of a COVID-19 Patient After Stem Cell Treatment

Improved Outcomes from an Alternative Strategy

Noting the limited effectiveness of these measures, Dr. Soni designed a plan to treat the patient using stem cells. Research physician Dr. Michael J. DeMarco coordinated the plan, with day-to-day care provided to the patient by Dr. Miller and his Critical Care fellows Dr. Rutwik Patel and Dr. Harish Sharma, at Saint Michael’s.

Following treatment with AlloRx Stem Cells® from Vitro Biopharma, a Colorado-based company, the patient began recovery from multiple organ failure and a coma of almost 7 weeks.  He had excellent recovery of his pulmonary, liver, and renal functions, ultimately coming off dialysis and ventilator support.

The patient’s recovery of neuro-muscular functions is evident in improved clarity of speech, ease of swallowing food, and many other everyday functions. Additionally, the elevated levels of inflammation markers seen prior to stem cell therapy have come down to within normal range. The patient was finally discharged from ICU, and is undergoing physical therapy with strong hopes of complete recovery.

COVID-19 and Mesenchymal Stem Cells (MSCs)

COVID-19 infection leads to uncontrolled release of proinflammatory cytokines – known as “cytokine storms” – that potentially leads to fatal damage of many organs of the body. “MSCs have specific characteristics that, when infused in the bloodstream,” explained Dr. Srivastava, “neutralize proinflammatory cytokines (through ‘immunomodulation’), down-regulate the inflammatory gene actions and send messages to regenerate damaged lung and other tissues, which may help in managing COVID-19.”

Next Steps for Treatment of COVID-19

“We got outstanding results after using MSCs on our first patient,” noted Dr. Soni, “with similar results being reported by other institutions.” Dr. Srivastava states that “the use of MSCs may be a great option not only for critically ill COVID-19 patients, but also for those who may have risk of exposure. MSCs may prevent people from aggravations of the infection, thereby potentially saving lives while lowering the load on hospitals and the economy.” Drs. Srivastava and Soni emphasize that a placebo-controlled, double-blind study would be needed to better understand the measurable outcome of stem cell treatment for COVID-19.

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 Mr. Deven Patel, the San Diego-based Institute has a tradition of groundbreaking research in stem cell science spanning over two decades.

 Media contact

Deven Patel
deven@giostar.com

Related Links

https://www.giostar.com/category/news/
https://www.giostarchicago.com/news
https://www.prnewswire.com/news-releases/giostar-reports-on-a-positive-outcome-of-a-covid-19-patient-after-stem-cell-treatment-301100889.html

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