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.

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://giostar.com/

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GIOSTAR Launches Stem Cell / Cancer Research and Therapy Center in Chandigarh, India

CHANDIGARH, India, Feb. 5, 2020 /PRNewswire/ — Global Institute of Stem Cell Therapy and Research (GIOSTAR), a leading provider of regenerative medicine, is proud to announce the inauguration of a new stem cell / cancer research and therapy center in Chandigarh, India. This facility represents the latest milestone in global expansion efforts spearheaded by GIOSTAR in India, Mexico, the United States, and numerous other countries.

GIOSTAR Chandigarh occupies 4 stories and 12,000 square feet, with a sleek, modern design that “reflects the cutting edge, elite science that GIOSTAR has been delivering for over two decades,” according to GIOSTAR Co-Founder and CEO Deven Patel. Following the recent opening of a center in New Delhi, it is the most recent in a series of hospitals being launched throughout the country. Future plans for expansion include Kolkata and Bangalore.

Chandigarh is noteworthy for having been the first planned city in India, designed by famed Swiss architect Le Corbusier. Located in Northern India, it is one of the country’s wealthiest cities, ranking the highest for Human Development Index (HDI) (a measurement of standard of living, literacy rates, and life expectancy). In addition to its verdant gardens and abundant shopping and dining offerings, Chandigarh is home to several prestigious research institutions such as Panjab University and Baba Farid Medical University.

Several key luminaries in the field of medical research, including Drs. S. S. Gill, Sanjeev Puri, Seemha Rai, and Amandeep Singh participated in the inauguration, delivering remarks about the state of regenerative medicine in India. “GIOSTAR is proud of our tradition of excellence in research,” noted GIOSTAR Co-Founder and Chairman Dr. Anand Srivastava, “and we are privileged to welcome such influential leaders in the field on this auspicious occasion.”

Continued Collaboration, Sustained Impact
GIOSTAR has long played a central role in the evolution of regenerative medicine within India. This began with the 2011 launch of the world’s first dedicated stem cell therapy hospital in Gujarat, resulting from a landmark partnership with Prime Minister of India Shri Narendra Modi.  GIOSTAR is also collaborating with a few state governments of India. “These partnerships have been very beneficial,” noted Patel, “as they enable GIOSTAR to deliver regenerative therapies to millions of people suffering from degenerative disorders and cancer.”

Additional highlights of GIOSTAR’s worldwide efforts include:

• Launch of a stem cell therapy center in Cancun Rivera, Mexico, regarded as one of the world’s premier tourist destinations
• Collaboration with large pharmaceutical company in China to launch clinical trials for cerebral palsy for children
• Conditional approval for Type 2 Diabetes clinical trial in Bahamas, where nearly 15% of the population suffers from the disease
• In-depth discussions between delegations of Ahmedabad, India and Kobe, Japan, to foster additional investment opportunities between the two “sister cities”
• Process of FDA approval for clinical trials for Type 2 Diabetes and other disorders in the United States

“2020 will be a very bright year, with unlimited potential for the field of regenerative medicine,” noted Patel. “There’s a great deal of work yet to be done, however, and GIOSTAR will continue leading the charge – in Chandigarh, and around the world.”

About GIOSTAR

GIOSTAR is the pioneer and established leader in the field of regenerative medicine for sports injuries, joint arthritis afflictions, and additional degenerative conditions. The Institute’s advanced techniques and protocols have been extensively researched and developed by Dr. Anand Srivastava and GIOSTAR’s leading scientists for more than 20 years.

Source : https://www.prnewswire.com/news-releases/giostar-launches-stem-cell–cancer-research-and-therapy-center-in-chandigarh-india-300999284.html

GIOSTAR Launches Stem Cell Therapy Center in Cancun Riviera

PLAYA DEL CARMEN, Mexico, Jan. 14, 2020 /PRNewswire/ — Global Institute of Stem Cell Therapy and Research (GIOSTAR), the pioneer in stem cell-based technologies, is proud to announce the launch of a new stem cell therapy center in the Cancun Riviera, Mexico. With this announcement, GIOSTAR further bolsters its leadership in the global medical tourism market, which is projected to grow at a compound annual growth rate (CAGR) of 16.1% for the next 5 years. The Cancun Riviera center highlights GIOSTAR’s continued expansion of its presence in Mexico, which also includes facilities in Los Algodones and Guadalajara.

Stem cells are unspecialized unique body cells that may help patients better manage symptoms of multiple sclerosis, arthritis, and other degenerative diseases. In addition to its clinics such as GIOSTAR Cancun Riviera, the GIOSTAR management team collaborates closely with leading government agencies to create stem cell therapy and research programs in Japan, China, Costa Rica, and Thailand. “This center is a testament to the commitment from the thousands of patients GIOSTAR has treated throughout the world,” noted GIOSTAR CEO and Co-Founder Deven Patel. “It’s only because of their trust in our capabilities that we’ve been able to grow our infrastructure.”

GIOSTAR Cancun Riviera offers several key benefits, including:

• Great vacation destination: Cancun has long been regarded as one of the world’s most attractive vacation destinations, with beautiful beaches, vibrant nightlife, and ample shopping opportunities.
• Easy access: the GIOSTAR facility is located near Mexico’s second largest airport (Cancun International Airport), making it accessible via direct flights from numerous cities throughout the world.
• Therapies backed by decades of research: GIOSTAR Cancun Riviera’s highly skilled professionals are trained extensively in the lab techniques and protocols developed by GIOSTAR Chairman and Co-Founder, Dr. Anand Srivastava.

Due to these advantages, Mr. Patel remarked that “this center helps GIOSTAR to continue executing on our mission to make the most advanced, elite, and expensive science available to the masses.”

As with the GIOSTAR center in Los Algodones, Mexico, GIOSTAR Cancun Riviera is integrated with other facilities such as the Sani Dental Group dental clinic. This provides patients the opportunity to receive comprehensive health care while taking advantage of the amenities offered in the surrounding Playa del Carmen area.

Additionally, the colors of the walls and furniture, the wood used in the fixtures, and other aesthetic elements of the center are closely aligned with those of the Mayan Riviera. “We wanted the center to look as authentic (yet modern) as possible,” noted GIOSTAR Mexico Chief Operating Officer Alejandro Gutiérrez. “The Cancun Riviera facility reflects Dr. Srivastava’s belief that stem cell therapy patients will maximize their success rate when they’re in a relaxed state of mind.”

Upcoming plans for 2020 include an “official inauguration event” in February, along with tentative plans to open an additional center in Mexico.

About GIOSTAR

GIOSTAR is the pioneer and established leader in the field of regenerative medicine. Under Dr. Anand 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.

Source : https://www.prnewswire.com/news-releases/giostar-launches-stem-cell-therapy-center-in-cancun-riviera-300986482.html

GIOSTAR Signed MOU To Develop Advanced Stem Cell Center at Calicut University Kerala

GIOSTAR Chairman and Co-founder Dr. Anand Srivastava and Vice Chancellor, Dr. Mohammed Basheer of Calicut University,  Kerala Signed an Agreement to Develop Advanced Stem Cell Center under the direction of GIOSTAR

GIOSTAR Diabetes Type-2 Pre IND Clinical Trial – US FDA

GIOSTAR Diabetes Type-2 Pre IND Clinical Trial – US FDA

GIOSTAR – Diabetes Type-2 Clinical Trial with US-FDA News in “The Introducer”

GIOSTAR Engaged with USA FDA to Carry 0ut Stem Cells-Based Clinical Trial for Diabetes Type 2

Diabetes is increasing at a rampant rate all around the globe which is affecting developed countries more severely than developing ones. In the USA itself, almost 10% of the population has been living with diagnosed or undiagnosed diabetes. Since such a big section of the population is affected by diabetes, the cost of taking care of the individuals is also increasing. According to an assessment by the Diabetes Association of America, the cost of taking care of diabetics had added up to $327 billion in 2017. Out of which $237 billion was direct medical cost and remaining because of reduced productivity. Type II diabetes, which is caused by loss of insulin sensitivity is seen more commonly in the older population. However, with increasing easy and unimpeded availability of high-calorie foods and decreasing factors necessitating physical work, it is showing up in the younger population significantly. About 193,000 Americans under the age of 20 years are estimated to have diagnosed diabetes.

Though a number of medications are already in clinical use, none of them grant a long-term cure and all of them have some or other undesired side effects. To circumvent all these concerns another alternative way of handling the problem was needed for a long time. Discovery of stem cells and related extensive research has offered a ray of hope to manage the problem efficiently with a sound possibility of a permanent cure. Stem cells, depending on the source of their origin or due to post-isolation manipulations, are classified as embryonic or adult or induced.

Keeping different facts in a view, GIOSTAR Chairman, Dr. Anand Srivastava, started his research to differentiate stem cells into the insulin-secreting cells, which may be used for therapeutic purposes. Therefore, GIOSTAR is in the process of USA-FDA approval for a clinical trial to develop a stem cell-based treatment for Diabetes type 2. DR. ANAND SRIVASTAVA, M.S., PH.D. – CHAIRMAN, CO-FOUNDER, AND CHIEF SCIENTIFIC OFFICER

Mesenchymal stem cells (MSCs), isolated from visceral fatty tissues of adults, are known to promote the regeneration of pancreatic islet beta cells, protect them from apoptosis, and ameliorate insulin resistance in peripheral tissues by providing a supportive niche microenvironment driven by the secretion of paracrine factors or the deposition of the extracellular matrix. In general, implantation of MSCs can alleviate T2D by a number of mechanisms that include reducing systemic oxidative stress, a factor responsible for causing the death of insulin-producing cells and at the same time, contributing to insulin resistance too. Also, these cells, after being exposed to pro-inflammatory cytokines like IFN-g, become a source of anti-inflammatory cytokines. These cells, if implanted directly in the pancreas, due to their multipotential ability to differentiate in diverse types of cells of their immediate vicinity, can produce new insulin-producing cells. To promote the chances of their differentiation into insulin-producing cells, their preprogramming has been tried. Also, 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.

Encouraging findings in cases of diabetes treatments with stem cell therapies have led many clinicians to try implantation or infusion or both in the clinics. In more than 150 trials at different stages listed on NIH’s webpage implantation or infusion of MSCs have shown promising results up to several months of follow up. A couple of clinical parameters like H1Ac and needed insulin to manage blood glucose decreased after the MSC-treatments, which was also accompanied by increased insulin sensitivity.

Stem cell therapy may have some undesirable effects, though the incidences are few and far between. Even those undesired effects like mild to moderate fever or nausea or headache, which happen after stem cell transplantation, are very mild and are easily manageable.

In conclusion, GIOSTAR Chairman Dr. Anand Srivastava stated that stem cell therapy may offer a long-lasting therapeutic alternative for treating T2D. At the same time, it has to be kept in mind that it is not a permanent cure yet. T2D is a metabolic syndrome manifesting after a long duration of an unhealthy lifestyle that needs to be addressed in order to lead a healthy life. Compared to all other available therapies, stem cell therapy may offer a lot longer drug-free periods for individuals to develop a healthy lifestyle in order to fend off the re-occurrence of the disease.

Deven’s Networking Interest:  Hospitals and clinics interested in partnering for clinical trials.

Linkedin:  https://www.linkedin.com/in/deven-patel-38991455/

Website:  http://giostar.com/

Source : https://www.theintroducermagazine.com/league-members-innovating-for-diabetics/