Recruitment of the UF Center for Regenerative Medicine for a trial on a potential therapy for autoimmune disorders

Cells from the lining of the umbilical cord in culture.the University of Florida Center for Regenerative Medicine today announced the launch of a clinical trial to test safe doses of umbilical cord-derived stem cells in the treatment of two debilitating autoimmune disorders.

The Phase I trial, in collaboration with the biotech RESET, will include nine patients who will receive intravenous infusions of umbilical cord lining stem cells, or ULSCs, to treat dermatomyositis and polymyositis. These are rare conditions that can cause disabling muscle weakness and skin inflammation, which in turn can lead to serious problems with other organs in the body, including the lungs and heart.

The assay is approved by the US Food and Drug Administration and the Institutional Review Board a U.F. Healtha committee of doctors, nurses, pharmacists, researchers and members of the community that ensures the protection of the rights and safety of patients.

The trial, which is also expected to provide early evidence on the ability of these ULSCs to improve patients’ condition, is believed to be the first of its kind in the United States to test treatments for these disorders. If the Phase I trial is successful, a Phase II trial will be conducted to test the efficacy of a treatment in a much larger number of patients.

“We are excited to embark on this groundbreaking and important research as we examine potential therapies for these intractable diseases,” he said. david r nelson, MD, senior vice president of health affairs at UF and president of UF Health. “We are excited about collaborating with RESTEM on this novel approach and grateful for the generous donor support.”

The current trial, which is privately funded, recently began recruiting patients, he said. keith march, MD, Ph.D., director of the UF Center for Regenerative Medicine. Several people have already been treated.

“In an autoimmune condition, the immune system attacks the body’s own tissue,” March said. “Our hope is that this new stem cell approach will have an anti-inflammatory effect through a lowered immune response, thus protecting the body. If the therapy works, this stem cell therapy could help patients avoid having to take immunosuppressive drugs with potentially significant adverse side effects. Right now, those drugs are the only known treatment for these disorders.”

March said scientists believe that physiologically, these cells play an important role in modulating or influencing the body’s immune response, often dampening the aggressiveness of that response.

For example, these stem cells from the lining of the umbilical cord have recently been used to treat COVID-19 patients in an attempt to suppress the runaway immune response that can be so deadly with the new coronavirus infection.

“It’s a pleasure to work with the incredible center for regenerative medicine at the University of Florida,” said Rafael Gonzalez, Ph.D., senior vice president of research and development for RESTEM. “We are excited to launch this study and explore the potential effectiveness of our new, patented umbilical cord lining stem cell therapy.”

RESET and Carl J CucumberMD, professor at UF School of Medicine‘s division of cardiovascular medicine and the principal investigator of the study, are collaborating with michael bubbMD, Associate Professor at the UF School of Medicine division of rheumatology and clinical immunology.

About the UF Center for Regenerative Medicine

The mission of the UF Center for Regenerative Medicine is to accelerate the discovery, development and delivery of cell-based therapies for patients with unmet medical need. The center emphasizes a multi-specialty approach, including medical, surgical, and rehabilitation practices. Its physicians and scientists work collaboratively with researchers at UF Health and across the country, as well as colleagues in the biotech industry to test and implement regenerative cell therapies to target diseases that currently lack effective solutions and to improve the lives of patients. In addition to the study addressing dermatomyositis, teams at the UF Center for Regenerative Medicine are conducting and planning many other regenerative medicine studies. These include studies evaluating cell-based treatments for severe heart failure requiring left ventricular assist devices, rare diseases such as Duchenne muscular dystrophy, as well as more common health problems such as osteoarthritis and joint pain/swelling. knee joints and lower back.


RESTEM is an innovation-driven, clinical-stage biotechnology company, headquartered in Corona, California, dedicated to the discovery, development, and commercialization of novel, next-generation, cell-based therapies and tools that aid in the treatment of a wide range of of degenerative disorders. The company’s mission is focused on improving the quality of life of those who suffer from disabling diseases of the immune system, age-related disorders and other degenerative diseases. With more than 14 years of research and development focused on the company’s novel and proprietary umbilical cord lining stem cells, or ULSCs, which have novel regenerative properties believed to be superior to mesenchymal stem cells, RESTEM has become a major contributor to cell-based technology. treatments with ongoing clinical trials that address significant unmet medical needs in a variety of diseases and disorders.

Media Contact: Bill Levesque, [email protected] or 352-265-9417

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