Sanford Health adds stem cell trials

Jason Hurd and Mark Lundeen smile at camera in front of the Vatican.

VATICAN CITY –- Sanford Health leaders and legendary golfer Jack Nicklaus talked about stem cells as medicine today at an international health conference in Rome.

“The Pharmacy of the Future” was the title of their presentation, which focused on how the health system is using stem cells.

The conference, “Unite to Cure: The Fourth International Vatican Conference – How Science, Technology and 21st Century Will Impact Culture and Society,” brings together leaders in health care, science and research from around the world as part of the Cura Foundation conference, which is held every other year in Rome. This is the second time Sanford Health has presented at the invite-only event. Robin Smith, M.D., president of the foundation, also serves on the Sanford International Board.

The presenters for this panel, moderated by Sanjay Gupta, M.D., include:

  • Jason Hurd, M.D., Sanford Orthopedics and Sports Medicine
  • Mark Allen Lundeen, M.D., Sanford Orthopedics and Sports Medicine
  • Jack Nicklaus, 18-time Major Championship Winner and World Golf Hall of Fame Member
  • Eckhard Ault, M.D., Ph.D., Founder and chairman of the board of Isar Klinikum in Munich and InGeneron Inc. in Houston

“Stem cell procedures are being done at commercial clinics across the U.S., but it’s important for patients to know what treatment they’re getting and what it’s been proven to treat,” Lundeen said. “Clinical trials are the only way for us to understand the science of stem cells in the treatment of injury and disease. We’re fortunate here to have the infrastructure and institutional support to do these trials and find out everything we can so we’re moving forward in smart, therapeutic ways.”

Sanford Health has been aggressive in pursuing research related to adipose-derived stem cells.

The Food and Drug Administration recently approved two new clinical trials involving adipose-derived stem cells for the health care system, bringing the total trials to four, with a fifth pending.

“Despite all the technical advances we’ve made over the past few decades to improve the mechanical properties of rotator cuff repairs, we still have not solved the biologic problem of how to consistently make a rotator cuff heal to bone once it’s reattached,” Hurd said. “Learning how to improve the biology of healing is really the future of treatment not only for rotator cuff repairs, but for orthopedics in general. Hopefully through continued research we can find ways to improve the biologic potential of injured tissues to heal and in turn help our patients achieve better results.”

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. That trial reached full enrollment in May 2017. The 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. “Having FDA approval for these studies – and having so many of them – validates the work we’re doing.”

The latest trials:

  • The Rotator Cuff Pivotal Study is a Pivotal study that 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. It will enroll 210 participants nationwide, with 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., is the lead principal investigator for this study.
  • The Facet Joint study is a Feasibility trial that 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. This study will enroll 40 patients – 20 will undergo a liposuction procedure, and 20 will receive standard of care treatment. Thomas Boetel, M.D., is the principal investigator for this study.
  • 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 Feasibility trial will study the safety and efficacy of using adipose-derived stem cell therapy as a treatment for the wounds. The trial will accept 36 participants. It is being led by Bradley Coots, M.D., a plastic surgeon at Sanford Health.

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. Sanford Health’s cell therapy techniques focus on adipose-derived stem cells because they can be used in many parts of the body and are easily collected. Adipose stem cells yield many times more cells than other sources like bone marrow. They also can be returned to the body quickly, and they have a low infection rate.

Pearce is eager to share the news of what Sanford is doing this week in Rome.

“It’s invaluable for us as researchers to be part of this conference,” Pearce said. “These are some of the best and brightest in the industry, and every time we go, we are inspired by our colleagues to work harder to advance treatments and search for cures.”

The event is the continuation of a collaboration among The Cura Foundation, Stem for Life Foundation, a nonprofit organization devoted to advancing global awareness of regenerative medicine and cell therapy, The Vatican’s Pontifical Council for Culture and its foundation, STOQ (Science, Theology and the Ontological Quest).

To learn more about Unite To Cure: The Fourth International Vatican Conference, please visit: Or, you can follow the event on Twitter @CuraFdn and on Facebook at, and join the conversation with #UnitetoCure.


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