Stem cell research at Sanford Health set for next phase

At a glance:

What is stem cell therapy?

Cell therapy, according to Sanford Health experts, uses the body’s own cells as therapy. Stem cells, in particular, have the ability to repair or regenerate cells that are damaged or killed as the result of injury or disease. This is also known as regenerative medicine.

Does Sanford Health provide stem cell therapy?

Yes, through clinical trials. Sanford Health participates in several FDA-approved clinical trials using adipose-derived regenerative cells, which include stem cells.

Why have an FDA-approved clinical trial?

Sanford Health continues to work through the FDA and clinical trials process to make sure patient safety, rigorous research standards and clinical practices guide our work with regenerative cells.

Learn more: Regenerative medicine at Sanford Health

SIOUX FALLS, S.D. — Early results from a clinical trial using adipose-derived regenerative cells to treat rotator cuff injuries indicate that the treatment is safe and tolerated well by participants.

Top line results recently were reported by the study sponsor, InGeneron Inc.

The FDA-approved trial, which enrolled participants at Sanford Health, was the first of its kind in the United States, launching in 2016. Sanford Health participates in several clinical trials using adipose-derived regenerative cells, which include stem cells, and more will open later this year.

David Pearce, Ph.D., president of Sanford Research and Innovation, praised the collaboration and the work with the U.S. Food and Drug Administration.

“It is important for us that any study in which we are involved goes through all the proper channels, with rigorous clinical trials and the approval of the FDA,” Pearce said.

The rotator cuff trial, which uses cells taken from a participant’s own abdominal fat, reached full enrollment in May 2017. In December 2018, InGeneron Inc. reported data that the company’s autologous point-of-care cell therapy is safe and well-tolerated. A pivotal trial will open this year at 15 sites and enroll up to 246 participants.

Sanford Health will have two sites in the trial.

Industry leaders

Sanford Health continues to work through the FDA and clinical trials process to ensure rigorous research standards, patient safety and clinical practices guide its work with regenerative cells.

Pearce and Tiffany Facile, director of regenerative medicine at Sanford Health, presented at the Phacilitate Leaders World and World Stem Cell Summit (WSCS) at the Hyatt Regency Miami on Jan. 22-25, 2019.

Facile presented on regulations surrounding regenerative medicine.

“We want to make sure we’re following every guideline possible to ensure the rigor of the research we are involved in,” Facile said. “We’re excited to present on our work and show others possible pathways to finding uses for adipose-derived regenerative cells.”

Current trials

The current regenerative cell trials Sanford Health participates in include:

The wrist and facet studies are currently enrolling. Information is available at (605) 312-6020.

Find a clinical trial: Open clinical trials at Sanford Health

About cell therapy

Cell therapy, according to Sanford Health experts, uses the body’s own cells as therapy. Stem cells, in particular, have the ability to repair or regenerate cells that are damaged or killed as the result of injury or disease.

The combined 15th Annual Cell & Gene Therapy World, 14th Annual World Stem Cell Summit, Immuno-Oncology Frontiers World and Cord Blood & Perinatal Stem Cells Summit brings the advanced therapies communities together for a revolutionary gathering in Miami, Florida. 

Phacilitate Leaders World was honored to receive the award for Best Global Conference at the 2018 AEO Awards in London. This year, Phacilitate and RMF attracted 1,600 attendees from 38 countries, 120 exhibitors and 300 speakers representing every major stakeholder group.

For the latest additions to the agenda and world-renowned speakers, visit phacilitate-leaders-world.com.

This story was originally published on Jan. 16, 2019. It was updated on Sept. 18, 2019.