FDA approves COVID-19 trial after successful emergency use of umbilical stem cells from RESTEM


CORONA, Calif., and MIAMI and SIOUX FALLS, S.D., May 14, 2020 /PRNewswire/ -- RESTEM, a leading cell-based therapeutics company, announced today it has received approval from the U.S. Food and Drug Administration (FDA) for a 60-patient Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of COVID-19. The study will be the first of its kind in the U.S.

"We are excited to launch this study and demonstrate the potential of our patented umbilical cord lining stem cell (ULSC) technology," said Dr. Rafael Gonzalez, senior vice president of research & development for RESTEM. "Based on the properties of our cells and targeted treatments, our breakthrough technology has shown promise to help those suffering from COVID-19 complications."

This treatment has already shown promising results in patients in the U.S. hospitalized with COVID-19 who also had developed acute respiratory distress syndrome (ARDS). These patients were previously treated at Miami Cancer Institute, part of Baptist Health South Florida, under the care of principal investigator Guenther Koehne, MD, PhD, deputy director of the Miami Cancer Institute. The patients, who were all on ventilators, were treated with umbilical cord mesenchymal stem cells under an emergency approval from FDA, and two have now been discharged from the hospital.

The randomized, placebo-controlled and blinded study will look at whether this may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19.

The multicenter phase I/IIa study, officially known as the Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial, will be completed in collaboration with Baptist Health South Florida in Miami, Florida and Sanford Health in Sioux Falls, South Dakota, for COVID-19 patients who have developed ARDS.

This study will be a collaborative effort between multiple institutions including Florida International University Herbert Wertheim College of Medicine, Baptist Health South Florida, Sanford Health, and a biotechnology lab, RESTEM.

The study is expected to start enrolling patients from Baptist Health South Florida and Sanford Health this week.  

"Based on the initially observed improvement of the patients treated, we are now looking forward to enrolling these severely ill patients onto the clinical trial. We are grateful to the FDA to have this clinical trial reviewed and approved in a timely manner during this difficult time," said Dr. Guenther Koehne who is also the chairman of the Department of Translational Medicine at Herbert Wertheim College of Medicine (HWCoM) at Florida International University and the principal investigator of this clinical trial.

Sanford Health will also be a key strategic partner for this study. "We're excited to bring a potentially breakthrough treatment to our patients with the most severe cases of COVID-19," said David A. Pearce, PhD, president of innovation and research at Sanford Health. "It's a privilege to partner with RESTEM on this groundbreaking approach, which has already shown remarkable promise."  

RESTEM's cells are grown from umbilical cord tissue by a proprietary process that allows millions of doses to be replicated rapidly. The SUCCESS trial will identify COVID-19 ARDS patients who could best benefit from ULSC and will develop randomized placebo-controlled evidence about the ability of these cells to heal patients with this disease.

Patients will be able to participate in the SUCCESS clinical trial both at Miami Cancer Institute and at Sanford Health.

Media Contacts:
Georgi Morales Pipkin, Baptist Health

David Duckenfield, RESTEM

Angela Dejene, Sanford Health
(218) 280-0148

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), 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 Sanford Health
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 44 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and nine countries. Nearly $1 billion in gifts from philanthropist Denny Sanford have transformed how Sanford Health improves the human condition. For information, visit sanfordhealth.org or Sanford Health News.

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 FacebookInstagramTwitter and LinkedIn.


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SOURCE Sanford Health


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