SAN DIEGO — A San Diego-based stem cell research institute believes its discovery may have saved the life of a COVID patient on death’s doorstep.
GIOSTAR infused a 53-year-old man in a coma with Mesenchymal stem-cells taken from an umbilical cord. Prior to that, all other treatments were failing.
“He was having a stroke, he was under dialysis, liver function was declining,” said Dr. Anand Srivastava, co-founder of GIOSTAR. “Nothing was working.”
The patient, whose identity is not being released due to privacy laws, had been in a coma in a New Jersey hospital. GIOSTAR got special clearance from the Food and Drug Administration to try the stem-cell treatment.
Srivastava said the patient began to recover, gradually over three weeks.
“Slowly, his renal and liver function came closer to normal,” he said. “He came out from the intubation, and now he is talking.”
The family, in an interview with GIOSTAR, said they had lost all hope.
Srivastava said this treatment could be key as society awaits a vaccine.
GIOSTAR is planning to do a double-blind study to confirm its conclusions about its treatment. It says that study should take about three months.
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).
Improved Outcomesfroman 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.
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.
Mesenchymal Stem Cells May Be A Credible Alternative Therapy To Fight With COVID-19 Pandemic
Coronavirus disease 2019 (COVID-19), a highly contagious disease, is propelled by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). First identified in December 2019 in Wuhan quickly forced the World Health Organization (WHO) to declare the 2019–20 coronavirus outbreak a Public Health Emergency of International Concern (PHEIC)on 29 January 2020 and a pandemic on 11 March 2020.1-3 Following the emergence global powers are scrambling in search of reliable treatments urgently, and vaccines for future use. The deathly pathogenic virus has caused more than 3 million cases and two thousand deaths worldwide by April 29th, inciting the fear that the numbers may continue to increase. Common symptoms of COVID-19 include, but are not limited to, fever, cough, fatigue, shortness of breath, and loss of smell sense. Severe additional symptoms included in the list but not limited to are difficulty in breathing, persistent chest pain, confusion, and difficulty in waking up.While many cases only display mild symptoms, others may manifest a form of viral pneumonia leading to multi-organ failure and could be fatal.4-6 The viral infection causes a vicious release of different proinflammatory cytokines or a cytokine storm thought to be the root cause of organ failures.5 The virus has been recorded to spread between humans following a close contact with someone who has been infected,via small droplets that come from coughing or sneezing.Many humans can also get infected by being even in the vicinity of an infected person or after coming in contact of a contaminated surface and thentouching their face. The standard method of diagnosis and testing used by many countries is the method of real-time reverse transcription polymerase chain reaction (rRT-PCR) from a nasopharyngeal swab. Chest CT imaging isalso helpfulduring the diagnosis stage; however, CDC guidelines do not recommend chest scans for routine screening.
COVID-19 affects the lungs the most, because the virus attacks host cells via the angiotensin-converting enzyme 2 receptor (ACE2). ACE2 is found on the surface of different cell types but type II alveolar cells present in the lungs are very rich in its content. The virus has a surface glycoprotein called a “spike” (peplomer) which helps in accessing the ACE2 and invade the host cell. Therefore, density of ACE2 in the cells of a tissue is related to with the severity of the effect of the infection. Considering its role in infection, many scientists have hypothesized that decreasing ACE2 activity might have positive effects in inhibiting infection. Though an opposing view also exists according to which increasing ACE2 activity by using angiotensin II receptor blocker may be protective.Both of these ideas need to be rigorously tested before either of these could be a guiding force for developing a therapeutic intervention. When the alveolar disease begins to progress, respiratory failure may begin and death may result. The virus also attacks gastrointestinal organs as ACE2 is present.
Currently, there is no available vaccine or specific antiviral treatment for COVID-19. Management involves the treatment of symptoms, supportive care, isolation, and experimental measures. Because of the emergent need, medical professionals have rushed
Approval of MSCs for therapeutic is gaining acceptance around the globe.In Japan, MSCs have been approved for the treatment of another clinical condition called graft-versus-host disease.There are other such pending approvals in the US also as a number of clinical trials starting to test the benefits of MSCs for treating COVID-19 are at different stages.Many scientists, on the basis of the immune- modulatory ability of MSCs and other circumstantial evidence, think that MSCs should alleviate the symptoms in COVID-19 patients. It was evident by the Chinese study, which was reported in “Aging and Disease” last month also.The findings based on seven COVID-19 patients who received intravenous infusions of MSCs recovered successfully and were discharged from the hospital by the end of the 14-day observation period. In contrast, of the three patients of the control group receiving regular treatment, all of whom had severe disease, one died, one developed ARDS, and one achieved a stable condition.7,8
Many scientists see that MSCs could be a very promising approach for treatment of COVID-19 patients though the findings are based on a small number of subjects.Other scientists also think that the report demonstrates that the MSCs are not only well received by the patients but also impart a great therapeutic relief. Following the recent approval by FDA of the treatment for extreme cases and trials together with the recruitment of COVID-19 patients to existing MSC trials for ARDS around the world a significant amount of data will demonstrate the therapeutic value of allogenic stem cell-based treatments in COVID-19 patients. Reviewing all the developing data, we suggest that clinicians may safely use MSCs to manage those patients who are in severe condition. MSCs may also be used as a credible preventive therapy to make the immune system ready to fight the virus in case of any possible COVID-19 infection.
Prabhat Soni, Anand Srivastava
Global Institute of Stem Cell Therapy and Research (GIOSTAR),
Global Institute of Stem Cell Therapy and Research (GIOSTAR),
4660 La Jolla Village Drive, San Diego, CA, 92122, USA,
Received: May 01, 2020 | Published: June 11, 2020
1. Symptoms of Coronavirus. U.S. Centers for Disease Control and Prevention (CDC).
2. Q&A on coronaviruses (COVID-19). World Health Organization (WHO).
3. Hopkins, Claire. Loss of sense of smell as marker of COVID-19 infection. Ear, Nose and Throat surgery body of United Kingdom.
4. Hui DS, I Azhar E, Madani TA, et al. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health—The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis. 2020;91:264–266.
5. Puja Mehta, Daniel F McAuley, Michael Brown, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. The Lancet. 2020;395(10229):1033–1034.
6. “Q&A on coronaviruses”. World Health Organization (WHO).
7. Gu Jinyang, Han Bing, Wang Jian. COVID-19: Gastrointestinal manifestations and potential fecal-oral transmission”. Gastroenterology.
8. Leng Zikuan, Zhu Rongjia, Hou Wei, et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia[J]. Aging and disease. 2020;11(2):216–228.
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.
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.
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.”
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.
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.”
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.