Rotator Cuff Study Among Two New Stem Cell Trials at Sanford

Two new clinical trials involving adult stem cells are launching at Sanford Health.

The Food and Drug Administration recently approved the additional adipose-derived stem cell projects. The approval brings the total number of FDA-approved clinical trials involving adipose-derived stem cells at Sanford to four, with a fifth pending.

Sanford Health had the first FDA-approved adipose-derived stem cell trial in the United States in 2016, with cells taken from a participant’s own abdominal fat used to treat rotator cuff injuries. Health care officials report that one-year follow-up visits are ongoing for enrolled patients and will be completed in May 2018. Data will be reviewed and study reports will be completed by the end of summer 2018.

“We know the future of medicine is trying to help the body repair itself, and we’re doing everything we can to move in that direction,” said David Pearce, Ph.D., vice president of research and innovation for Sanford Health, in a statement. “Having FDA approval for these studies – and having so many of them – validates the work we’re doing.”

The latest trials include:

  • The Rotator Cuff Pivotal – opens in July. It will be a continuation of the initial rotator cuff study and further investigate the potential effects of adipose-derived stem cells on rotator cuff tears. There will be room for 210 participants nationwide, with 30 from Sanford Health locations in Sioux Falls, South Dakota, and Fargo, North Dakota.
  • The Facet Joint study – opens this summer. This trial will investigate the potential healing factors of adipose-derived stem 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.
  • The Wrist Osteoarthritis study is a Feasibility trial that opens in June. It will investigate the potential healing factors of adipose-derived stem 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 stem-cell injections and half will receive a steroid shot. Participants will not know which treatment they receive. Robert Van Demark, Jr., M.D., is the principal investigator for this study.
  • A trial for non-healing leg wounds that opened in September 2017 continues. The trial will accept 36 participants.

Sanford Health is presenting on stem-cell research and therapies and regenerative medicine at the Unite to Cure conference this month at the Vatican in Rome, Italy.

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