New Therapy Breaks Ground in the Fight Against COVID-19
April 29, 2020 – RESTEM, a leading-edge biotechnology company, and Baptist Health South Florida, today announced three COVID-19 patients with acute respiratory distress syndrome (ARDS) are the first to successfully be treated in the U.S. with umbilical cord mesenchymal stem cells under an emergency approval from the Food and Drug Administration (FDA).
Baptist Health physicians, Guenther Koehne, M.D., Ph.D., and Javier Pérez-Fernández, M.D., safely administered the new treatment to patients through intravenous infusions of RESTEM’s experimental umbilical cord lining-derived stem cells (ULSC).
The patients who received this treatment showed reduction of their oxygen requirement from 100% to less than 50% within days of the infusion, accompanied by significant reduction in levels of various key circulating inflammatory markers.
“The remarkable ability for these cells to mitigate inflammatory processes holds great promise for COVID-19 patients as well as for people with many other illnesses,” said Guenther Koehne, MD, PhD, deputy director and chief of blood & marrow transplant at Miami Cancer Institute, part of Baptist Health. “These patients have improved their lung status much more quickly than patients treated with other experimental therapies,” added Dr. Koehne, who is also professor and chairperson of the Department of Translational Medicine at the Herbert Wertheim College of Medicine (HWCOM) at Florida International University (FIU). Specialists at HWCOM spearheaded this collaborative effort between academia, Baptist Health and RESTEM.
“Our preliminary results show that therapy with these cells could be a game-changer in COVID-19,” stated Dr. Javier Perez-Fernandez, pulmonologist and director of critical care at Baptist Hospital of Miami.
RESTEM’s cells are grown from umbilical cord tissue by a proprietary process and reduce inflammation, thereby allowing tissue regeneration and healing to occur.
Rafael Gonzalez, PhD, Senior Vice-president of Research and Development at RESTEM, stated “we are extremely excited with these preliminary results. The SUCCESS (Systemic Umbilical Cord Cells to Erase Syndrome Severity) Trial will identify COVID-19 ARDS patients that may best benefit from ULSC and will develop randomized placebo-controlled evidence regarding the ability of these cells to heal patients with this terrible disease.” Dr. Koehne is the Principal Investigator of the SUCCESS Trial undergoing review at the FDA entitled “Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients with ARDS due to COVID-19.”
The RESTEM ULSC have also been cleared by the FDA for testing their healing properties in the autoimmune conditions of Polymyositis and Dermatomyositis. Patients will also be able to participate in this clinical trial both at the Miami Cancer Institute and at Sanford Health in Sioux Falls, South Dakota.
About RESTEM
RESTEM is a leading-edge biotechnology firm dedicated to the discovery and development of cell-based therapeutics and tools that aid in the treatment of human degenerative disorders. The company focuses on improving the quality of life for those who suffer from disabling diseases of the immune system and other severe infirmities. With over 12 years of research and development on umbilical cord lining stem cells (ULSCs) of which have properties of mesenchymal stem cells, RESTEM has emerged as a major contributor to cell-based therapy treatments based on the unique properties of its patented cell technology.
About Miami Cancer Institute
Miami Cancer Institute brings to South Florida access to personalized clinical treatments and comprehensive support services delivered with unparalleled compassion. No other cancer program in the region has the combination of cancer-fighting expertise and advanced technology—including the first proton therapy center in South Florida, Latin America and the Caribbean, and one of the only radiation oncology program in the world with each of the newest radiation therapies in one place—to diagnose and deliver precise cancer treatments that achieve the best outcomes and improve the lives of cancer patients. The Institute offers an impressive roster of established community oncologists and renowned experts, clinical researchers and genomic scientists recruited from the nation’s top cancer centers. Selected as Florida’s only member of the Memorial Sloan Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of a meaningful clinical collaboration that affords patients in South Florida access to innovative treatments and ensures that the standards of care developed by their multidisciplinary disease management teams match those at MSK.
Miami Cancer Institute is part of Baptist Health South Florida, the largest healthcare organization in the region, with 11 hospitals, more than 23,000 employees, 4,000 physicians and 100 outpatient centers, urgent care facilities and physician practices spanning across Miami-Dade, Monroe, Broward and Palm Beach counties. Baptist Health has internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences. In addition, it includes Baptist Health Medical Group; Baptist Health Quality Network; and Baptist Health Care On Demand, a virtual health platform. A not-for-profit organization supported by philanthropy and committed to its faith-based charitable mission of medical excellence, Baptist Health has been recognized by Fortune as one of the 100 Best Companies to Work For in America and by Ethisphere as one of the World’s Most Ethical Companies. For more information, visit BaptistHealth.net/Newsroom and connect with us on Facebook, Instagram, Twitter and LinkedIn.
About FIU
Florida International University is Miami’s public research university, focused on student success. According to U.S. News and World Report, FIU has 44 top-50 rankings in the nation among public universities. FIU is a top U.S. research university (R1), with more than $200 million in annual expenditures. FIU ranks 15th in the nation among public universities for patent production, which drives innovation, and is one of the institutions that helps make Florida the top state for higher education. The Next Horizon fundraising campaign is furthering FIU’s commitment to providing students Worlds Ahead opportunities. Today, FIU has two campuses and multiple centers, and supports artistic and cultural engagement through its three museums: Patricia & Phillip Frost Art Museum, the Wolfsonian-FIU, and the Jewish Museum of Florida-FIU. FIU is a member of Conference USA, with more than 400 student-athletes participating in 18 sports. The university has awarded more than 330,000 degrees to many leaders in South Florida and beyond. For more information about FIU, visit www.fiu.edu.
