compliance

noun  com·pli·ance  \ kəm-ˈplī-ən(t)s \

  1. The state or fact of according with or meeting rules or standards.

Regenerative medicine is a relatively new and exciting treatment that’s providing many to experience less orthopedic pain. We at Regen Colorado have incorporated this into our pain medicine practice due to the promising evidence of healing orthopedic ailments. Because of regenerative therapy’s youth in the world of orthopedic musculoskeletal medicine, it’s still not 100% perfected, guaranteed, or fully understood. Here’s what we do know; an immense amount of research has been done in the field of regenerative medicine and is progressing quickly. Unfortunately, this field is also being pulled and stretched by physicians and providers that are spewing out misleading and false information.

Is it out of ignorance? Perhaps. Grey areas, loopholes and fraudulent statements? Very likely.

Let’s first revisit what it means to be FDA compliant. The Food and Drug Administration (FDA) is a government-appointed agency who regulates everything from the United States food to what is classified as a drug. Drugs are to be approved by the FDA before they are released to the public. The FDA does not do its own testing of new drugs, medical devices, or other items. [ Source: Rottenstein] It relies on working with the manufacture’s results of clinical testing and studies. The process includes human trials to fit scientific standards and the safety of humans.  The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer’s clinical trials and research. [1]  After conducting all the information obtained, the FDA decided whether or not to approve the drug.

 

Simple enough, but what is classified as a drug? That question is not so simple. The FDA has categorized human cell and tissue products (HCT/P) in two sections called 351 and 361 HCT/P. 351 products are regulated as a drug and require FDA approval, 361 HCT/P are not regulated as a drug and therefore do not endure the rigorous approval process. However, once a 361 is either manipulated, introduced with another substance, has an effect on multiple areas of the body, and used for anything other than homologous use (more on that later), it no longer meets guideline criteria. [Source: Rosenthal] So are stem cells drugs? No, but when the rules of a 361 qualification are not met, trouble lurks. This is what the FDA has their eye on and for good reason!

 

Let’s break it down. Stem cells are all throughout our bodies. They are the pre-existing building blocks of signaling the body to heal various ailments. In our case, orthopedic conditions. The medical community has never classified our own biologics to be a drug until regenerative treatments were introduced. Removing stem cells from the body is not the issue, placing them in an orthopedic joint or intervertebral disc is still not a concern; it all goes back to how it fits the 361 guidelines and how it is administered. Manipulation, Adipose, IV administered stem cells and placental tissue or amniotic fluid are four major areas that do not meet the FDA’s guidelines and therefore are not compliant.

 

Manipulation

Minimal manipulation of the cell is important. Once it’s manipulated, according to all the guidelines in place, you’ve created a drug. So how is this measured? When you take a natural biologic and relocate it without manipulation through infusing with other products (biologic or not) it’s considered minimally manipulated. Manipulation is simply altering original relevant characteristics. This is why the FDA has considered adipose, IV administered, and amniotic placental stem cell therapy to not be compliant to their guidelines.

 

Adipose (Fat) Derived Stem Cell Therapy

There are two main reasons why adipose has fallen into the drug category. First, the stem cells that are in fat are hard to isolate from the fat tissue. In order to separate, it’s introduced with a chemical enzyme. At this point, the tissue has been manipulated. Second, fat and tissue provides structure, padding, and cushioning. If you isolate cells from adipose tissue, thus turning it into a liquid form, you are manipulating that said structure.

 

IV Administered Stem Cells

This is the process of extracting stem cells from adipose or BMC then administering those stem cells though an IV. This is generally performed to “treat” various non-orthopedic aliments. Claims of treating such diseases as MS, ALS, Parkinson’s, COPD, Crohn’s etc. Why is this not compliant? One, there is very little research in this department of regenerative medicine. Two, no clinical evidence of success and three, does not fall into the category of homologous use (extremely important when regarding the FDA’s guidelines). Homologous use means that the transplanted matter must perform the same function as it previously resided. For example, stem cells that are in bone marrow repair and regenerate bone marrow stroma. [Source: Rosenthal]

 

Amniotic Tissue

Where to begin with this one? If you’re still reading at this point, you’re going to see how this one is a long shot from the guidelines discussed. Amniotic tissue is amniotic fluid of a human placenta frozen in a vial. Stored, shipped, frozen and then thawed easily qualifies as manipulation. This product does not fall into the category of homologous use or autologous use due to it being transplanted in an area that does not perform the same functions and is not from the individual themselves.

These are the ones that are currently getting away with misinformation and threatening the overall integrity of the regenerative medicine field. They claim that there are live stem cells in the product. If that is the case they are violating the FDA’s 361 guideline. However, a recent study conducted by the Interventional Orthopedic Foundation determined that there are no living stem cells in these products. Could it contain growth factors? Probably, but that’s not what is being sold. What’s being sold are stem cells. When you claim a product is something that it is not, that’s not only a distrust to a patient, but highly fraudulent.