GIOSTAR Announces FDA Approval Under Compassionate Use for a COVID-19 Clinical Trial with Stem Cells
May 1, 2020
SAN DIEGO, May 4, 2020 /PRNewswire/ -- 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 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.
Media Contact:
Deven Patel
[email protected]
Related Links
https://www.giostar.com/2020/05/01/giostar-announces-fda-approval-compassionate-use-treat-covid-19-stem-cells-2/
https://giostarchicago.com
SOURCE GIOSTAR
More News
'It's rough out here': Americans struggle with rising inflation
US inflation continues to rise, and this month the jump was above forecasts. Here's how some are surviving.
Toilet paper and secret recorders: What we know about the arrest of the Saudi OpenAI engineer
Abdulrahman Alfozan had worked for the AI giant for more than a year before he was arrested by the FBI.
Federal Judge Again Blocks Trump’s Ban on CNN, MS NOW and Politico
The ruling will allow the outlets to enter the White House grounds while they sue to overturn the ban. But it doesn’t resolve all of their access problems.
China’s Exports Soar, Putting Its Trade Surplus on Track for a Record
China’s exports grew last month at the fastest pace in almost any month since the end of the global financial crisis.
US inflation rises more than expected - here's what is happening with prices
The pace of price rises increased to 3.7% in the year to September, driving by higher motor fuel costs.
5 Costs Americans Are Paying More for as Inflation Rises
Consumers are paying more for everyday goods and services, like food, computers and streaming.
Social Security COLA for 2027 Will Be 3.6%
The cost of living adjustment, or COLA, for next year will be the largest since 2023. Retirees will see the extra money in their benefit checks starting in January.
Gas Prices Are Up 34% From a Year Ago, Adding to Inflation Pressures
Energy prices have surged since the start of war with Iran, lifting inflation in the United States.
Rising Costs Push Necessities Out of Reach for Nearly Half of Americans
Inflation has made basic goods hard to afford and attitudes toward inequality have changed, studies from the Pew Research Center showed.
Driving test waits fall to two-year low - but still average 20 weeks
Learner drivers in September had to wait an average of 19.7 weeks, or around five months, for a practical test.
Musk Blames Tycoon for Stalling Satellite Internet Access in India
As Starlink seeks permission to operate in India, a recent protest in New Delhi showed how quickly authorities can cut off mobile internet access.
Hollywood Agents and Producers Push to Restore Glory Days of Indie TV
A new alliance seeks legislation to force the biggest entertainment and streaming companies to devote half of their content budgets to independent producers in the U.S.
YOUR NEWS, OUR NETWORK.
Do you have Great News you want to tell the world?
Be it updates about your business or your community, you can make sure that it’s heard by submitting your story to our network reaching hundreds of news sites across 6 verticals.