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

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).

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 neuromuscular 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.

Critically ill COVID-19 Patient Successfully Treated with Vitro Biopharma’s AlloRx Stem Cells(R)

(OTC PINK:VODG), dba Vitro Biopharma, jointly with GIOSTAR – a San Diego, California-based institution headed by Dr. Anand Srivastava, a pioneer in stem cell science – announced the results of treatment of a critically ill COVID-19 patient with its lead clinical product AlloRx Stem Cells®.

This patient was admitted to an emergency room with classic COVID-19 symptoms in late April and had several comorbidities prior to admission. While intubated in the intensive care unit (ICU), the patient’s condition worsened using the standard of care and treatment with convalescent plasma. The patient’s kidney and liver function began to fail, requiring dialysis. Additionally, the patient experienced sepsis and a stroke while in the ICU and was comatose for almost 7 weeks.

Following the treatment with AlloRx Stem Cells®, the patient experienced resolution of multiple organ failure, recovery from coma, and restoration of neurological, pulmonary, liver and renal function. The patient was removed from assisted respiration and dialysis. The patient now eats, drinks, speaks, and has regained motor function. Measures of inflammation that were elevated at admission and rose during ICU treatment, returned to normal levels. The patient has recently been discharged from ICU and is currently undergoing physical therapy to recover from the stroke suffered while in the ICU.

This study was authorized by the FDA through an Investigational Drug Application (eIND) for emergency use under expanded access granted to GIOSTAR, Vitro Biopharma’s partner in stem cell therapy for COVID-19 using AlloRx Stem Cells® as the therapeutic agent. GIOSTAR Medical Director Dr. Prabhat Soni oversaw the clinical management of the patient and all related clinical/regulatory issues. Vitro Biopharma is pleased to partner with GIOSTAR to provide expanded offerings of AlloRx Stem Cell® COVID-19 therapy to its expanding global clientele, while at the same time expanding treatment to US COVID-19 patients through eIND and pending INDs.

Dr. Anand Srivastava, MS, PhD, GIOSTAR’s Chairman and Chief Scientific Officer said “COVID-19 infection triggers the spectrum of inflammatory cytokines, which results in severe COVID-19 induced pneumonia and acute respiratory distress syndrome (ARDS), followed by multiple organ failure. Utilizing the natural immunomodulatory character of AlloRx Stem Cell® (Mesenchymal Stem Cells or MSCs) may be one of the best ways to neutralize COVID-19 induced inflammatory cytokines actions on lung and other organs to rescue the patients suffering from COVID-19 infection.”

Dr Jack Zamora, MD, Vitro Biopharma’s Chief Medical Advisor said, “The miraculous recovery of our first critically ill COVID-19 patient using AlloRx Stem Cells bring great hope in these troubling times. We continue with our FDA IND application with even greater hope of delivering a promising treatment to US patients, and through GIOSTAR, we have reached out to various Ministries of Health worldwide with this promising news.”

“We are pleased to have achieved this milestone that was based on thorough understanding of the science of stem cell biology,” said Dr Jim Musick, CEO of Vitro Biopharma. “While regeneration of destroyed cells is a common effect of stem cell therapy, stem cells also regenerate damaged cells by various regenerative processes that restore normal organ function. The results of this case support the further study of AlloRx Stem Cell® Therapy for COVID-19 patients and other conditions characterized by acute respiratory distress that are ultimately related to the inflammatory cytokine cascade that is neutralized by AlloRx Stem Cells®. Our therapy appears to have significant therapeutic application in treatment of multi-organ failure related to COVID-19 infections.”

“The results with this patient are quite remarkable,” stated Dr. Soni, Chief Medical Officer, Giostar, Inc. “It is highly likely that the patient would have died without stem cell therapy, because the combination of organ failure and comorbidities yielded a very poor prognosis. We are pleased to partner with Vitro Biopharma and look forward to providing this therapeutic option for slowing the pandemic on a global scale.”

About Vitro Biopharma:

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells® now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells® to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas www.tmp-bahamas.com in Nassau.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Chrohn’s disease and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

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

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.

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.