SANTA MONICA, Calif., April 20, 2020 /PRNewswire/ -- A single patient, emergency Investigational New Drug (IND) use was cleared by the U.S. Food and Drug Administration for the treatment of severe lung injury due to COVID-19 at the Providence Saint John's Health Center, Santa Monica, CA with intravenous administration of ischemia-tolerant allogeneic mesenchymal bone marrow cells (itMSCs) manufactured by Stemedica Cell Technologies, Inc.
Dr. Santosh Kesari, Director of Translational Neurosciences and Neurotherapeutics at John Wayne Cancer Institute, Pacific Neuroscience Institute, and Providence Saint John's Health Center, was familiar with expanded access use of investigational treatments for serious and life-threatening conditions. "I was consulted about compassionate use options for a patient with respiratory failure from COVID-19 infection. The patient was not a candidate for currently available clinical trials and had already received treatment with anti-IL-6, anti-retrovirals, hydroxychloroquine, and convalescent plasma," said Dr. Kesari. "Our team was running out of options."
Having collaborated previously with Stemedica, Dr. Kesari reached out to the company to see if their itMSCs could be used for the patient. The potential use of MSCs to facilitate regeneration of damaged lung tissue and to tamp down an overactive immune response, two factors contributing to respiratory failure, is under intense investigation.
Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer at Stemedica added, "This IND application for emergency use was supported by pre-clinical data in an acute respiratory distress syndrome (ARDS) model. These data provide important evidence that Stemedica's itMSCs exhibit potent therapeutic effects in pre-clinical models of infection-related lung injury. The results show: (1) improved survival in pre-clinical model of Acute Respiratory Disease Syndrome treated with itMSCs delivered by either the intratracheal or intravenous route; (2) enhanced bacterial clearance in the lungs of animals infected with bacteria; and (3) increased secretion of paracrine factors, such as angiopoietin-1, that mediate reparative effects following lung infection and injury. The IND application was also supported with safety data of itMSCs in humans obtained in several clinical trials conducted under FDA INDs sponsored by Stemedica."
Dr. Nikolai Tankovich, the President and Chief Medical Officer at Stemedica commented: "It is significant that our stem cell product has helped ICU physicians to stabilize a COVID-19 critical condition patient by reducing systemic inflammation and partially resolving pneumonia in combination with the standard protocol treatment. I believe that combined stem cell and medication therapy will allow physicians to stabilize critically ill Acute Respiratory Distress Syndrome patients, assisting them continue with their recovery."
An application for the Expanded Use IND to treat additional patients was submitted to the FDA by Dr. Kesari and a Phase II study is in development by Stemedica.
About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell, protein and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company's lead drug candidate, ischemia-tolerant mesenchymal stem cells, or itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of ischemic stroke, chronic heart failure, cutaneous photoaging, and Alzheimer's disease. The company's second drug candidate, ischemia-tolerant neural progenitor cells, or itNSCs, is an allogeneic cell therapy currently in development for spinal cord injury. More information on Stemedica may be found at www.stemedica.com.
About Pacific Neuroscience Institute Pacific Neuroscience Institute (PNI) is devoted to the comprehensive care of patients with a wide spectrum of neurological and cranial disorders. Dedicated teams of specialists, state-of-the-art facilities and the use of leading-edge treatment along with our collaborative approach ensure that each patient receives the attention they require for successful treatment and recovery. PNI's specialty clinics are located at award winning hospitals Providence Saint John's Health Center in Santa Monica and Providence Little Company of Mary Medical Center in Torrance, California. www.PacificNeuro.org
About Providence St. Joseph Health Providence St. Joseph Health is a national, not-for-profit Catholic health system comprising a diverse family of organizations and driven by a belief that health is a human right. With 51 hospitals, 829 physician clinics, senior services, supportive housing and many other health and educational services, the health system and its partners employ more than 119,000 caregivers serving communities across seven states – Alaska, California, Montana, New Mexico, Oregon, Texas and Washington with system offices based in Renton, Wash., and Irvine, Calif.