Federal Judge ruling: using patients' stem cells to treat medical conditions does NOT fall under FDA jurisdiction

Good news for cell based therapies in the US?

Landmark case: US federal judge rules that using patients’ stem cells to treat a variety of medical conditions does NOT fall under the FDA’s regulatory jurisdiction.

The lawsuit was brought on by the US FDA in 2018 against California Stem Cell Treatment Center (CSCTC) in an effort to assert regulatory authority over stem cell therapies.

This is a huge ruling in favor of patients seeking to utilize their own stem cells as part of a medical treatment.

In a mass email distributed by the Global Stem Cell Group:

" This news opens up the possibilities and sets an important precedent for clinics in the United States to use autologous cellular treatments derived from adipose tissue, giving patients the right to use their own tissue to enhance regenerative processes and fight disease."

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This sounds good but I’m sure the powers that be will create laws that will give the FDA regulatory jurisdiction over stem cell treatments. It’s just a matter of time.

Also, the major players in hair regeneration now - are not just “using patients’ own stem cells”, but actually manipulating somatic (body) cells to create new induced pluripotent stem cells (Stemson) or directly reprogramming somatic cells into new hair follicle stem cells (dNovo). Yes, they get the original cells from the patient’s own body but then they transform those cells into another kind of cell. In both cases, they’re also using these newly grown cells to form follicles outside the body, which are then implanted at an early stage into the skin. I’m not sure if this will qualify to avoid some level of FDA review because they’re adding one or more steps of biochemical manipulation to the cells they originally harvest.

But for all those clinics that are doing things like harvesting adipose tissue and extracting stem cells, then injecting the stem cells into the scalp, this will probably remove all regulatory review. It should be very easy for them to operate now, not just for hair growth but to treat a whole range of degenerative conditions, such as arthritis, eye conditions, skin wrinkles (maybe), hormonal and gland conditions (maybe) and even spinal cord injuries. For hair growth, the problem is these direct harvest-and-inject procedures offer much less clear cut results than what is envisioned by Stemson and dNovo.

On the positive side, in theory, this MIGHT help the FDA review process for Stemson and dNovo move faster because it’s an acknowledgment that at least part or parts of their procedures may now be considered relatively safe.

The problem with the FDA is those in charge are forced to follow outdated policies. That is the problem with government as whole. Technology is advancing very fast while the FDA is moving at the speed of a turtle. This is really good news!!! Many of these studies are similar yet they all have to go through the same process. If one part has already been proven safe why does the next research group have to prove that it is safe again?

I agree but if some patients die or get injured from stem cell treatments there could be calls for laws giving the FDA jurisdiction over stem cell treatments. The deaths/injuries wouldn’t even have to be because the tech is dangerous. It could be because some labs/technicians do shabby work but deaths/injuries could prompt the govt to give the FDA jurisdiction over the technology. It would be nice if the stem cell industry got together and produced a governing body of their own so they could inhibit the proliferation of charlatan stem cell clinics. If the industry is smart that’s what they’ll do.

@jarjarbinx what you described can happen with any medical procedure and would fall under medical malpractice lawsuit.

The truth is that there is virtually ZERO, i mean a negligible, statistically insignificant, risk of cancer from extracting a patient’s own stem cells and then putting them back into the same patient’s body. And that’s why this court ruling makes total sense. They just affirmed the obvious.

In this case nothing is being done to alter the stem cells, they’re the exact same cells that were taken out of the body. The only differences are that they’re in more concentrated form (for example from centrifuging adipose tissue), and are being placed back into a different part of the body.

What people might be getting confused about is other experimental procedures involving drugs that might affect the proliferation of stem cells (or other kinds of cells) while INSIDE the body. Like for instance the Janus kinase inhibitor drugs that Dr Christiano has been experimenting with.