Breakthrough Regenerative Therapy Approved by FDA for COVID-19 Study Focuses on Patients with ARDS

May 16, 2020 | ARDS, Coronavirus, COVID-19, Investor Watch, Mesenchymal Stem Cells, Regenerative Health, Sanford Health

Breakthrough Regenerative Therapy Approved by FDA for COVID-19 Study Focuses on Patients with ARDS

Sioux Falls, South Dakota-based Sanford Health was selected as one of just two sites to participate in a first of its kind study in the United States: a Phase I/IIa study using umbilical cord mesenchymal stem cells to treat patients with severe cases of SARS-CoV-2, the virus behind the COVID-19 pandemic. Both Sanford Health and Baptist Health South Florida will commence enrolling patients next week for the RESTEM-sponsored study. The commercial sponsor maintains a very low profile.


The study is sponsored by a company called RESTEM, based in Corona California. Led by senior vice president of research and development for RESTEM, Dr. Rafael Gonzalez, the company is testing its patented umbilical cord lining stem cell (ULSC) technology. The company’s premise is summarized by Dr. Gonzalez: “Based on the properties of our cells and targeted treatments, our breakthrough technology has shown promise to help those suffering from COVID-19 complications.”

FDA Approved Emergency COVID-19 Stem Cell Treatments Show Promise

The technology has already been used in emergency situations involving hospitalized COVID-19 patients combating acute respiratory distress syndrome (ARDS). These patients, according to a recent press release from Sanford Health, 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. Three patients who were in trouble—on ventilators—were treated with the umbilical cord mesenchymal stem cells under an emergency approval from the U.S. Food and Drug Administration (FDA). They have been discharged now and are in good health.

As reported in the Miami Herald, the doctors at Baptist Health South Florida used the technology they call a “game-changer” that could portend a new powerfully effective way to treat patients in intensive care. Dr. Javier Perez-Fernandez, critical care director at Baptist Health, who personally helped choose the three patients based in part on their specific conditions, commented for the Miami Herald, “And if it works as we expect, its going to change dramatically the way we treat these patients.”

The ‘SUCCESS’ Study

Based on the results experienced in South Florida, the new multi-center Phase I/IIa study titled “Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19” (SUCCESS) trial will be conducted with Baptist Health South Florida in Miami, Florida and Sanford Health in Sioux Falls, South Dakota for COVID-19 patients who have developed acute respiratory distress syndrome (ARDS). These patients face far greater risk for severe consequences, including mortality.

Collaborative Study

Sponsored by the commercial biotech RESTEM, the study involves multiple institutions—including Florida International University Herbert Wertheim College of Medicine, Baptist Health South Florida, Sanford Health, and an unnamed biotechnology lab.

FDA Shows Timely Flexibility

Dr. Guenther Koehne, chairman of the Department of Translational Medicine at Herbert Wertheim College of Medicine at Florida International University, and of course the principal investigator, emphasized his gratitude to the U.S. Food and Drug Administration (FDA) commenting, “Based on the initial 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.”

Stanford Health Gears up

The health system in the Great Plains area of the nation gears up for this novel and important study while David A. Pearce, PhD, president of innovation and research at Sanford Health, emphasized the provider’s excitement to participate in breakthrough research to help patients with severe SARS-CoV-2 cases while expressing the appreciation to partner with the biotech firm known as RESTEM.


There is not a lot of public information about this company, and this sparked the interest of the research team. TrialSite News secured patent information indicating the invention relates to umbilical cord lining stem cells (ULSCs) from humans, and more particularly, to the methods and materials for isolating, culturing, expanding, and characterizing UCSCs. The inventors of this regenerative therapy approach are J. Francisco Silva and Rafael Gonzalez; a company called DaVinci Biosciences was the patent filer, and actual technology patent was assigned to RESTEM LLC. The company appears to be somewhat of a mystery and the research team will surface additional information imminently.

Moreover, the original patent was filed by DaVinci Biosciences, which doesn’t seem to be involved with the study. The TrialSite News research news has additional information and, upon confirmation, will publish.

According to the recent press release, 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.

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.

The Technology

Based on the patent, the research centers will leverage the huge potential of this proprietary process used to grow umbilical cord tissue leveraged for the stem cell therapy treatments. The research team will identify in the SUCCESS trial ideal candidates that can benefit from ULSC in a quest to develop randomized placebo-controlled evidence as to the ability of these cells to heal patients with the deadly disease.

Lead Research/Investigators

Guenther Koehne, MD, PhD, deputy director of the Miami Cancer Institute, Principal Investigator

Dr. Javier Perez-Fernandez, critical care director at Baptist Health

Dr. Rafael Gonzalez, PhD, senior vice president of research and development for RESTEM

Call to Action: If you or a loved one knows of COVID-19 patients that may be developing ARDS, you may want to consider contacting the Miami Cancer Institute if based in South Florida or Sanford Health if in South Dakota.