Why Are Some Stem Cell Procedures Allowed While Others Are Not?

A Texas patient dealing with a soft tissue injury could make a visit to the Lone Star Pain Medicine clinic in order to receive stem cell injections. By the same token, a Florida patient suffering from macular degeneration would not be able to find a clinic offering legal stem cell injections for the disease. Why? Because not all stem cell procedures are allowed under FDA rules.

Even though the FDA is okay with some stem cell procedures, the number of those procedures is relatively small. According to the doctors at Lone Star, the same holds true across the entire spectrum of regenerative medicine. Regenerative procedures are only legal if they involve minimally manipulated autologous material. That is the proverbial line in the sand for regenerative medicine providers.

What It Means

The term ‘minimally manipulated autologous material’ doesn’t mean much to someone without a medical degree. Fortunately, it is an easy term to understand. Let us start with autologous material. This is biological material provided directly by the patient being treated.

Your blood is autologous material to you because it comes out of your body. It is foreign material to someone else. Likewise, stem cells taken from your bone marrow are considered autologous material if they are injected back into your body. If they are used to treating someone else, they are foreign material.

As for being minimally manipulated, this is with respect to what happens to the material between the time it is drawn and the time it is used for the patient’s treatment. This is where regenerative medicine gets tricky. Unfortunately, FDA rules are pretty ambiguous with respect to manipulation.

Stem Cell and PRP Injections

Clinics like Lone Star offer common regenerative procedures, including stem cell and PRP injections. If you were to undergo a stem cell procedure to treat osteoarthritis, your doctor would begin by drawing material from fat tissue or bone marrow. That material would be processed in a specialized centrifuge in order to concentrate the stem cells by separating unwanted material out of the sample.

This is considered minimal manipulation because your medical team is not adding anything to the material to change its structure. Likewise, putting the cells in a centrifuge does not change them biologically. Spinning in a centrifuge only concentrates the cells for maximum effect.

The same basic procedure is followed for PRP injections. Blood is drawn before being processed in a centrifuge to isolate platelets and growth factors. Nothing else is done to the blood.

Anything Else Is Illegal

From the FDA’s perspective, any procedures that go above and beyond what was just described are illegal without prior approval. To gain approval, a procedure has to undergo the rigorous testing that could take more than a decade to complete. The same goes for new drugs and medical devices. To date, the FDA has approved very few stem cell therapies outside of the minimally manipulated autologous arena.

As for those procedures that are allowed under the minimal manipulation guidelines, they are designed to encourage the body to naturally heal itself. Stem cells are especially powerful because they can become any type of tissue within their particular group. They show great promise for addressing all sorts of diseases and injuries for which we have few other options.

The lesson here is that some stem cell procedures are legally allowed by law. Others are not. The distinction between the two is as simple as FDA rules relating to minimal manipulation and tissue source. Minimally manipulated autologous material can be used by doctors to treat patients dealing with soft tissue injuries and musculoskeletal diseases.