A top FDA official talks cellular therapy with Sanford

If you're a prospective patient, go through a trusted source, says Dr. Peter Marks

Two men in suits talk while seated on modern yellow wing chairs in the corner of a hotel room.

When we say “orthobiologics,” we’re willing to wager you might say, “… what?”

It’s a term, along with “regenerative medicine,” that’s raised some eyebrows, particularly in the past few years. In the simplest possible explanation, the two terms mean using one’s own resources to fight injuries.

Regenerative med 101

Regenerative medicine is an area of medicine which uses cells to treat, repair, and in some cases regrow body tissues. One common example: skin grafts for burn victims.

Orthobiologics uses natural substances from one’s own body to treat injuries of the bones, joints and muscles. It is a form of regenerative medicine.

Sanford Health has placed an emphasis on both safely providing this treatment to patients and dispelling common myths.

The reason? Cellular therapy can be an excellent form of treatment. But there’s been a stigma attached. Partly because of bad actors who offer these treatments but haven’t gone through the rigorous safety measures Sanford Health has.

Working with the FDA

Those safety measures come from the U.S. Food and Drug Administration. Sanford Health has the most FDA-approved clinical trials when it comes to cellular therapies, orthobiologics, and regenerative medicine.

Sanford Health News had the opportunity to visit with Peter Marks, M.D., Ph.D, who’s the director of the center for biologics at the FDA, to chat about what cellular therapies are, and why it’s important to offer them the right way.

Dr. Marks explained he helps to ensure the products the FDA regulates, which includes cellular therapies, “are appropriately reviewed, and that we develop policies that help facilitate their safe and effective deployment.”

He said cellular therapies are a broad array of different therapies.

“They range from very simple things, like skin transplants or skin grafting, to very complicated things such as cells that are given to people to help eliminate cancers. In between, there are cellular products that have been developed to try to help people recover from injured joints.

“All of those things I’ve talked about are a range of things that are under investigation in the cellular therapy world,” he said.

Dr. Marks said some less-than-reputable providers sell the simplicity of cellular therapy but aren’t diligent when it comes to safety measures.

“On the other hand, there’s the other end of things where people are actually investigating what these cellular therapies can really do in rigorous clinical trials. Where they’re looking at whether people get better, or they don’t get better, and whether they’re safe or not safe.

“The cells have to be processed in a certain way. They have to be given in a certain way. And, we have to try to understand if they work.”

So, are cellular therapies safe for orthopedics?

It’s too early to tell, according to Dr. Marks. Yes, there are some products and procedures that are approved in this area, but not many.

“That said, they are a very reasonable thing for patients to pursue in terms of clinical trials, because they may actually hold a lot of promise to alleviating some of the issues that people have with degenerative joints. That’s the whole excitement in the field of regenerative medicine,” he said.

“Clinical trials right now are exploring whether cellular therapies can help heal joints, or relieve pain, and make a difference in people’s lives in terms of how their joints function. All of those things are quite exciting, but they’re in the process of clinical trials for most of these products right now,” he added.

Transparency is key

Because of this, it’s important for potential patients to go through a reputable and verified source for these treatments, Dr. Marks said.

“When someone is considering cellular therapy I think one, first of all, wants to feel comfortable that you’re dealing with a reputable entity. It should be somebody that you feel like you can find out about them and that you know what they are about. They should be interacting with you on a very transparent level.

“If they are looking at a clinical trial, clinical trials involve getting informed consent. They should be getting informed consent. They shouldn’t be asking to charge you an exorbitant amount of money for doing this. That’s not what these clinical trials are for.

“To sum up, the most important thing is to be able to feel confident you’re working with a reputable organization.”

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Posted In Innovations, Orthopedics, Research