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MED

Research Done Right: An Interview with Sanford’s President of Research and Innovation

Mar 27, 2019 09:00AM ● By Alyssa McGinnis

Earlier this year, Sanford announced that early results from a clinical trial using adipose-derived regenerative cells to treat rotator cuff injuries indicate that the treatment is safe and well-tolerated. The FDA-approved trial, which enrolled participants at Sanford Health, was the first of its kind in the United States, launching in 2016. Sanford participates in several clinical trials using adipose-derived regenerative cells, which include stem cells, and more are opening this year.

MED spoke with David Pearce, president of Sanford Research and Innovation, and Tiffany Facile, director of regenerative medicine at Sanford Health, about Sanford’s commitment to following the FDA’s clinical trial roadmap as it explores all that stem cells can do.

DP: We just completed our first rotator cuff stem cell trial with one-year followup with the 12 patients that received adipose-derived stem cells. We passed all safety criteria. The second criteria is asking whether there was efficacy. This is challenging to answer with a small trial. But we do think we saw improvement with the outcomes of these patients. The next step for this research is a multi-site clinical trial that will enroll patients from across the US.

TF: We could easily probably fill that study within the Sanford footprint. But the intent is to make this more real world. That is an example of the preclinical pathway we are talking about. You get the safety piece acknowledged and then you move into the efficacy part. Now, we want to get that data with the FDA in hopes that we can bring this to other patients.

DP: Regulators need to see that the same kind of results can be repeated elsewhere. Geographic diversity is also important so we’d look for sites that are more diverse than we are.

Healthcare is a business. Many people are advertising that they are doing stem cell work or regenerative medicine. A lot of times, these businesses are actually doing PRP [platelet-rich plasma], which is not stem cells, or are doing bone marrow aspirate or even fat grafts. But the efficacy of these approaches has not been shown and their efficacy is unlikely to be shown.

If Sanford started putting out this kind of misinformation, the FDA would come and visit us.

TF: It’s a naming piece, a clarification. Some of the folks claiming to be using stem cells may or may not even be using stem cells. Some say this falls in line with their medical training.

But FDA guidance has improved and is helping this industry move forward quicker and with a better understanding of how to get clinical trials out to patients. I presented in January at the World Stem Cell Summit in Miami. I wanted to let people know that, even though we are a large organization, we are still able to turn things around with the FDA quickly and we have done it the right way.

But the FDA is putting more eyes and ears on those bad actors. By November of 2020, they are saying either jump on the FDA train or jump off.

DP: This is an example where consumers are actually driving the medicine here. Consumers have read things and are encouraging doctors to put these unregulated things out there. But science is not keeping up with the demand for something that whose efficacy is based on anecdotal evidence.

One thing that is really disappointing is the amount of money that people are being charged for some of these unproven things. There is a certain trust that people have in a clinic that if they are offering something, it must work. If people are in pain they want to believe that what is going to be given to them is going to be helpful.

Our docs would not do a fraction of the procedures that you see advertised. They want to do the things with the most efficacy (which is adipose-derived stem cells) and they want to do what is sanctioned by the FDA.

TF: We believe that it is our duty to make sure that what we are providing is safe according to the FDA. You do that by running it through a clinical trial. You do your preclinical work, the “sciency” work. You ask ‘What are these cells? What is their potency?’ You have to answer those basic science pieces before you even approach the FDA. You have to start there. You begin with safety and then move onto the larger efficacy pieces.

We back up what we are using with an FDA-approved clinical study. But sometimes places will advertise that they are providing something using an FDA-approved device. The problem is that the device might not be approved for this procedure. There have been examples of physicians who have outwardly disagreed with the FDA and go ahead and offer an unproven procedure that they feel falls within their medical training.

DP: We are very optimistic about the future of this technology. We have stem cells throughout our body. As we learn to apply them in orthopedics, we hope to be able to apply them to deliver therapeutics around the body to wherever they are needed to be curative. But to conduct orthopedic clinical trials properly, you have stem cells removed by a plastics or a vascular person. In some settings, you have a radiologist involved, as well.

No other organization has the number of FDA-clear clinical trials as Sanford does. We both sat on platforms at the national conference. We are a national leader. People are congratulating us on our ability to work with the FDA because we are the only ones in the US with this portfolio. Sanford is going to be the organization that legitimizes the use of this.

As of now, we have four orthopedic clinical trials. We are also the first site for a similar type of cellular approach in Type one diabetes, which is a more complicated type of stem cell research.

TF: There may be applications in cardiology and liver disease. We are expanding our orthopedic platform. There are a few things that we are dabbling in, but certainly don’t have answers yet. We will follow FDA guidelines to provide safe and most effective treatment options for patients. We want to provide options for patients who don’t have good options.

We can’t do this without our scientists. We have been able to pull together and do this quickly and safely because we work collectively. It’s a group effort. The regulatory process is complex, which is why this collaboration is so important. How you go through the process and how you have your work validated matters.