(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.
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