By | November 6, 2017

The emergence of regenerative medicine as an alternative to pharmaceuticals and surgery has created a new market now being filled by a growing number of doctors and health clinics. And like any other industry, market growth tends to lead to confusion as the general public learns about the new products and services being offered. Amniotic products, and the confusion surrounding them, are a perfect example.

Stem cell therapies for things like pain management, wound healing, and osteoarthritis treatment are becoming more common. More often than not, clinics offering such treatments use autologous stem cell material taken directly from the person being treated. Still, there are clinics that use donor material from other sources. Sometimes that material is amniotic material that should not contain live stem cells.

The problem with this material, according to stem cell training company Apex Biologix, is how the FDA classifies it. Despite what you may have heard in the mainstream media, regenerative medicine procedures like stem cell and platelet-rich plasma therapies are not completely unregulated. The FDA regulates how all human tissue can be used for medical treatments. Where regenerative medicine is concerned, doctors are most interested in those regulations pertaining to 351 and 361 biologic material.

The 351 and 361 Classifications

The 351 and 361 classifications pertain to how the FDA regulates the use of human tissues. Most amniotic stem cell products are classified as 361 products because they are tissue rather than actual live stem cells – or at least they’re supposed to be. If an amniotic product does contain live stem cells, then it is no longer a 361 product. Instead, it is a 351 product. There is a very big and significant difference here.

According to section 1271 of the FDA regulations, a stem cell product containing living stem cells marketed as having some sort of metabolic effect are classified as 361 products if they come from third-party donors (not autologous). Here’s the catch: such material is considered to be an investigational new drug (IND) by the FDA. It cannot be used for medical procedures unless and until it undergoes lengthy clinical trials.

So what does this mean for amniotic stem cell products? It means that such products, if marketed as containing live stem cells with metabolic benefits, either:

  • Don’t really contain live stem cells and are thus being misrepresented; or
  • Do contain live stem cells in which case they are being used in violation of FDA regulations.

Neither scenario is very good for the emerging regenerative medicine industry. This is why so many doctors and clinics are wary of amniotic products.

Good Products Out There

Apex Biologix maintains that there are good amniotic products out there. For example, they work with a biotechnology company to develop innovative products and therapies based on allograft tissue. Allograft tissues are amniotic tissues that contain bioactive substances like collagen, proteins, and growth factors.

Such material is permissible for regenerative medicine treatments because it is genuinely 361 material. It is tissue rather than live stem cells. Apex says that the allograft material they and their partner use is derived from living, healthy donors following a full-term pregnancy and scheduled C-section. Each donor is carefully screened to ensure the quality of the donated tissue.

There are doctors and clinics offering regenerative medicine treatments using amniotic products. As long as those products are classified as 351 rather than 361 products, they can be safely used. It is up to doctors to poke around to get all the necessary information about the products they buy so as to ensure the safety of their patients.