GOLDEN, CO / ACCESSWIRE / April 21, 2020 / Vitro Diagnostics, Inc. (OTCPINK:VODG), dba Vitro Biopharma announced the filing an investigational new drug (IND) application with the FDA for clinical use of AlloRx Stem Cells® in the treatment of COVID-19 patients in the US. Recent umbilical cord stem cell therapies in China to fight the Coronavirus are producing encouraging safety and efficacy results. Seventeen critically ill patients treated with umbilical cord-derived stem cells that are comparable to AlloRx Stem Cells®, responded quickly by no longer requiring ventilator assisted breathing and were discharged. Also, the Israeli firm Pluristem recently reported recovery in six patients treated with similar stem cells derived from the human placenta. Together with prior safety studies conducted by Vitro Biopharma and others, there is a strong & compelling argument to allow clinical testing of AlloRx Stem Cells® for COVID-19 infections in our proposed Phase I study.
Dr. Jim Musick, Ph.D., CEO said, “We are very pleased to have submitted our IND using our expanded regulatory team, including a renown regulatory expert in FDA clinical trial management. We are establishing strong communication channels with FDA officials to facilitate and expedite review of our application as well as subsequent steps to gain full FDA approval of AlloRx Stem Cells®. Several clinical centers have expressed interest in our stem cell therapy. We are also pursuing other avenues for compassionate use and the COVID-19 Treatment Plan Acceleration Program. We are confident that our therapy is safe & effective based on our prior studies and those of others. MSCs block the cytokine storm that occurs in COVID-19 patients in acute respiratory distress through their powerful anti-inflammatory effects. The cytokine storm leads to the need for assisted breathing by ventilators, transfer to ICU and tremendous burdens on the US health care system. It is important to note that AlloRx Stem Cells® are therapy for other viral attacks including influenza since stem cells block acute respiratory distress and damage to other major organs including cardiovascular, pulmonary and renal systems. AlloRx Stem Cells® are very likely to assist in recovery from failure of various organ systems in COVID-19 survivors”
About Vitro Biopharma:
Vitro Biopharma, for over 10 years, has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with Mesenchymal Stem Cells, MSC-Grow™ Brand of cell culture media, various stem cell derivatives and stem cell-derived differentiated cells. We also supply primary fibroblast cells and an expanding line of cancer-associated fibroblasts (CAFs) from various tumors including lung, breast, melanoma, pancreatic and colorectal tissues. Our CAFs are purchased by major pharmaceutical and biopharmaceutical firms to advance immunotherapy of cancer.
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 ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.
Dr. James Musick
Chief Executive Officer
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