FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)
First-of-its kind study to be supported by the Cura Foundation, The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now
New York City (September 16, 2020) – The Cura Foundation in collaboration with The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now, is supporting a clinical trial of human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with Multisystem Inflammatory Syndrome in Children (MIS-C). The trial is being led by Dr. Joanne Kurtzberg at Duke University to determine if infusions of hCT-MSCs are safe and can suppress the hyper-inflammatory response and positively impact the symptom course and duration, as well as the long-term effects of this life-threatening syndrome. The hCT-MSCs are manufactured in the Robertson GMP Cell Manufacturing Laboratory at Duke. The U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) Application, and Dr. Kurtzberg will proceed with a multi-site pilot study later this month.
As the school year is underway more children are being diagnosed with the SARS-CoV-2 virus. According to the American Academy of Pediatrics (AAP), the cumulative number of coronavirus cases diagnosed in children has more than tripled between July 2 and September 3 from 165,845 to 513,415. As of September 3rd, children represent at least 9.8% of diagnosed cases in the U.S. and in states such as Alaska, Minnesota, Tennessee, South Carolina, New Mexico and Wyoming, children account for more than 15 percent of total cases. Some of these children have developed very serious disease. The Centers for Disease Control and Prevention reported that as of September 3rd at least 792 children in 42 states have been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C) and 16 have died.
The Principal Investigator of the study, Joanne Kurtzberg, MD, is the Jerome Harris Distinguished Professor of Pediatrics; Professor of Pathology; Director, Marcus Center for Cellular Cures; Director, Pediatric Blood and Marrow Transplant Program; Director, Carolinas Cord Blood Bank; Co-Director, Stem Cell Transplant Laboratory at Duke University School of Medicine/Duke Health and a leader in transplantation, cell therapy, and regenerative medicine in children. Clinical sites include Duke University (Durham, NC), Children’s Healthcare of Atlanta (Atlanta, GA), New York Medical College (Valhalla, NY), and others as cases occur.
“We hope this is just the beginning of our ability to support the development of cell therapies to treat COVID-19 Related Multisystem Inflammatory Syndrome in Children,” said Dr. Robin Smith, president of the Cura Foundation. “As students across the country return to in-class instruction, it is more important now than ever to ensure we are equipped with potential treatment options to care for children who develop this serious disease.”
About the Sponsors
The Cura Foundation leads a global health movement with the goal to improve human health. Cura unites public and private sectors, partnering with doctors, patients, business leaders, philanthropists and thought leaders to create a collaborative network that tackles major health issues and accelerates funding to advance innovations in medicine. Cura believes that by encouraging interdisciplinary approaches to medicine, promoting preventative measures and advancing the development of breakthrough medical technologies you can improve access to care, streamline health care delivery and eliminate social disparities in health care. The Cura Foundation is a nonsectarian, nonpartisan, public and tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code. For more information, please visit: https://thecurafoundation.org/
The Marcus Foundation was founded in 1989 by Bernie Marcus, co-founder and former CEO of The Home Depot, to support programs in Children and Youth Development, Community, Free Enterprise, National Security, Veterans, Jewish Causes, Healthcare and Medical Research.
Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health’s transformative work to improve the human condition at sanfordhealth.org or Sanford Health News.
Duke Health conceptually integrates the Duke University School of Medicine, Duke-NUS Medical School, Duke University School of Nursing, Duke University Health System, Private Diagnostic Clinic (Duke physicians practice), and incorporates the health and health research programs within the Duke Global Health Institute as well as those in schools and centers across Duke University, including the Duke-Robert J. Margolis Center for Health Policy.
Duke Health is committed to conducting innovative basic and clinical research, rapidly translating breakthrough discoveries to patient care and population health, providing a unique educational experience to future clinical and scientific leaders, improving the health of populations, and actively seeking policy and intervention-based solutions to complex global health challenges. Underlying these ambitions is a belief that Duke Health is a destination for outstanding people and a dedication to continually explore new ways to help our people grow, collaborate and succeed.
Alliance for Cell Therapy Now (ACT Now) is an independent, non-profit organization devoted to advancing the availability of and access to safe and effective cell therapies for patients in need. ACT Now convenes experts and stakeholders to develop and advance sound policies that will improve the development, manufacturing, delivery, and improvement of regenerative cell therapies. See http://allianceforcelltherapynow.org/
The Cura Foundation
Robin Smith, MD, +1-212-584-4176