Amniotic Stem Cells for Sale Online?

• Musculoskeletal and Spine 
• Orthopedics & Pain Management
• Wound Healing Issues
• Hair Restoration
• Cosmetic Indications
• Systemic Issues

Depending on how you read this, this product is being offered to treat at least 5 or 6 to 20 or more medical indications. Again, all claims that for an FDA-regulated product transform it from a 361 tissue into a 351 drug.

Now that we know that this product is not a loosely regulated tissue but instead a controlled drug, the big problem becomes that this drug product has no FDA approval. Since this distinction is where both physicians and patients get confused, let’s delve a little deeper into the differences. The gulf between what a 361 tissue registration entails and a 351 drug product needs for approval is broad and deep.

The ad copy claims that this product is FDA regulated, but while that’s technically correct, when you understand cell drug regulation, it’s deceiving. The 361 tissue registration filed for this product is an online form that’s filled out by the manufacturer. There are no clinical trials required nor drug approval process. Submit the form, and you’re done.

Contrast that simple 361 registration to a highly complicated, expensive, and time-consuming FDA cell drug approval. For the latter, there are preclinical experiments in animals that must be performed costing $1–3 million. Then the manufacturer must file for a biologics license, which will easily cost another $2–3 million. Then phase-1 trials will run another $1–3 million, phase-2 trials another $5–20 million, and phase-3 trials yet another $20-300 million. All of this takes somewhere around a decade to complete.

Also, while the physical site where these amniotic products are processed may have an AATB (American Association of Tissue Banks) registration, that means nothing to FDA if this tissue is considered a drug product. That’s because drugs are manufactured under much more stringent cGMP (current Good Manufacturing Practices). Any AATB site would fail a cGMP inspection across the board, as these drug-manufacturing regulations are far more extreme than a tissue processor could handle. Also, any surgery center or hospital would also fail.

In summary, the simple online registration that this amniotic product claims pales in comparison to an actual drug approval. Once this product is determined to be a 351 drug and not a 361 tissue (the existing voluntary registration), it needs a separate, full 3-phase and hugely expensive drug approval trial for every medical indication listed!

Why This New Trend Is Not Good for the Field

Physicians who are legitimately trying to use the patient’s stem cells or other autologous tissues to help patients have long argued that this is the practice of medicine and that the FDA has no right entering the regulation of medical practices. Many credible and compelling arguments can be made that the FDA is overstepping the law by regulating autologous tissues used by doctors as drugs. In fact, an impressive array of luminaries and experts showed up at the FDA hearing last month to argue just that. However, this new ploy to sell unapproved allogeneic stem cell products direct to physicians gives the FDA exactly what it needs to render meaningless all of the hard work that went into the effort to support a patient’s right to use his or her body parts. Why? While there is little doubt that the FDA doesn’t regulate the practice of medicine, there is also little doubt that it does control allogeneic tissues and cells. Hence, an entrepreneur trying to sell unapproved cell drug products online to any willing buyer gives the FDA the high ground in the argument against allowing any stem cell treatments to be performed. Why? They can now point to an area they clearly regulate and say with a straight face, “Look at how out of hand this stem cell treatment space has become.”

The upshot? This online amniotic tissue sales scheme is a new twist in the never-ending saga of consumer-level fraud that’s occurring with amniotic products. On the one hand, these products may contain important growth factors and may work more or less like an expensive PRP shot. On the contrary, they’re clearly not stem cell products. Now, by selling these products directly to physicians online and claiming that they have live cells that are effective for many indications, a new bright line has been crossed. No longer is the issue the physician’s right to use the patient’s cells the universal and compelling rallying call. Instead, the FDA has been provided with ample evidence that tighter regulation is required to rein in an “out of control” free-for-all stem cell treatment space.