Sanford Health adds two adipose-derived stem cell trials

By: Jacqueline Palfy .

Jason Hurd and Mark Lundeen smile at camera in front of the Vatican.
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SIOUX FALLS, S.D. –- The Food and Drug Administration recently approved two new clinical trials involving adipose-derived stem cells at Sanford Health.

The health system, based in the Upper Midwest, now has four FDA-approved clinical trials involving adipose-derived stem cells, 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. 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 clincial trials are:

  • 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.

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.

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.

“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.

About Sanford Health
Sanford Health is one of the largest health care systems in the nation, with 44 hospitals and nearly 300 clinics in nine states and nine countries. Headquartered in Sioux Falls, South Dakota, and serving the Upper Midwest, with nearly 1,400 physicians, Sanford Health is dedicated to several initiatives, including global clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. Sanford Health has 28,000 employees, making it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford over the past decade have transformed how Sanford Health can improve the human condition. For information, visit

About the Cura Foundation
The Cura Foundation leads a major global health movement, with the passionate purpose to improve human health. Cura unites public and private sectors, partnering with doctors, patients, business leaders, philanthropists and thought leaders to collaborate and create breakthroughs around the world. The foundation drives change by raising awareness of scientific advancements in genomics, emerging technologies and big data to usher in the future of medicine. Cura helps people live longer, better lives free from suffering. The Cura Foundation is a nonsectarian, nonpartisan, public and tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code. For more information, please visit:

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