At a glance:
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.
Yes, through clinical trials. Sanford Health participates in several FDA-approved clinical trials using adipose-derived regenerative cells, which include stem cells.
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.
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.
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.”
The current regenerative cell trials Sanford Health participates in include:
- The Rotator Cuff Pivotal Study opens this year. It will be a continuation of the initial rotator cuff study and further investigate the potential effects of adipose-derived regenerative cells on rotator cuff tears. It will enroll 246 participants nationwide, with up to 30 from Sanford Health locations in Sioux Falls, South Dakota, and Fargo, North Dakota. Participants will either receive an injection of stem cells or receive standard of care treatment. Jason Hurd, M.D., of Sioux Falls, South Dakota, and Mark Lundeen, M.D., of Fargo, North Dakota, are the lead principal investigators for this study.
- The Facet Joint study, sponsored by InGeneron Inc., is a safety trial that opened in 2018. This trial will investigate the potential healing factors of adipose-derived regenerative cells in patients with osteoarthritis of the facet joints. Patients must have chronic lumbar back pain due to facet joint osteoarthritis for more than six months and have failed three months of conservative back pain care. This study will enroll 40 patients –- 20 will undergo a minor liposuction procedure and receive injections of regenerative cells, including stem cells, and 20 will receive standard of care treatment. Tom Boetel, M.D., is the principal investigator for this study.
- The Wrist Osteoarthritis study, sponsored by InGeneron Inc., is a safety trial that opened in 2018. It will investigate the potential healing factors of adipose-derived regenerative cells in patients diagnosed with wrist osteoarthritis. There will be 40 patients enrolled in this study. All patients will receive a minor liposuction procedure, and then half will receive injections of regenerative cells, including stem cells, and half will receive steroids. Participants will not know which treatment they receive. Robert Van Demark, Jr., M.D., is the principal investigator for this study.
- Sanford Research is participating with Emory University, Duke University, and the Andrews Research Education Foundation on the MILES Study. This randomized phase 3 single-blind trial seeks to identify a superior source of stem cells for the treatment of osteoarthritis of the knee, and validate it over standard corticosteroid injections. The trial will begin enrolling this year.
The wrist and facet studies are currently enrolling. Information is available at (605) 312-6020.
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.
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This story was originally published on Jan. 16, 2019. It was updated on Sept. 18, 2019.