Florida Republicans introduce two bills to allow umbilical stem cell therapy: Here’s what you should know
Following Utah’s bills allowing clinics to offer umbilical stem cell therapy in 2024, Florida looks to do the same. The two bills, SB 1768 and HB 1617 were introduced by Republican representatives Jay Trumbull and James Buchanan. If they pass, Florida will seemingly go against the FDA’s guidelines and allow for umbilical cord stem cell […]
Following Utah’s bills allowing clinics to offer umbilical stem cell therapy in 2024, Florida looks to do the same.
The two bills, SB 1768 and HB 1617 were introduced by Republican representatives Jay Trumbull and James Buchanan. If they pass, Florida will seemingly go against the FDA’s guidelines and allow for umbilical cord stem cell therapy starting July 1st.
You can view/download both of the bills at the bottom of this post.
At a glance, the two bills are pretty similar. If this passes, here’s what clinics will be able to do:
- Umbilical stem cell therapy: The clinics may implant, transplant, infuse, or transfer stem cells for use “including, but not limited to bones, ligaments, skin, dura matter, heart valves, corneas, hematopoietic stem or progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.”
- English? Florida wants clinics to finally allow stem cell therapy to a wide range of body areas. They do mention “cord blood” specifically in SB 1768, however, they also go on to say “and other ethically obtained human cells, tissues, or cellular or tissue-based products” (HCT/Ps), which seemingly would include Wharton’s Jelly.
- It does mention they may not manipulate the tissues, which likely indicates that they may not culture-expand them.
- No explicit mention of exosomes, but if they’re made in a non-manipulated way, this is likely allowed.
There are some guidelines that clinics must meet in order to be compliant with the bill:
- Ethically-derived: Both bills urge for ethically derived therapies, essentially saying not from aborted fetuses/embryos. No surprise here being in Florida. Additionally, fetal-derived stem cells may be very powerful, but besides the ethical dilemma, from what I understand, researchers have a hard time safely harnessing these cells as they can turn into many more things than a multipotent mesenchymal stem cell, like you’d find in Wharton’s Jelly. There are cases of tumorgenic risks with fetal-derived cells.
- Must be within a licensed physician’s scope: Licensed MDs and DOs may use stem cell therapies within their scope for orthopedics, wound, and pain management.
- Must be made in an FDA-certified lab with proper GMP standards: The lab must be registered with the FDA, follow Good Manufacturing Practices (GMP), and be licensed/registered with one of the following organizations
- National Marrow Donor Program
- World Marrow Donor Association
- Association for the Advancement of Blood and Biotherapies
- American Association of Tissue Banks
- Physicians must give notices to patients: It looks like it will require physicians to put up posters around the clinic, make disclaimers on any advertising, and have patients sign a consent form. This consent form must outline the following:
- Nature of the treatment along with the FDAs approval status for that treatment
- Anticipated results
- Alternatives to this treatment
- Potential risks, complications, etc.
- Lastly, it explicitly excludes the use of adipose-derived cells.
This is a very interesting move by Florida. You have many clinics in the state already offering these therapies, in rogue/under-the-table fashion, clearly, there’s a demand for the products. If this passes, which I imagine it will seeing as the boss of the boss of the FDA (Bobby Kennedy) appears to be pro-stem cell therapy and the feds lost the Chevron Deference last year (this weakened federal power in court), there will be a lot of winners including:
- Dr. Ian White, founder of Neobiosis, a Wharton’s Jelly lab in Gainesville, FL. I have a few interview videos with him that will be trickling out over the next few weeks. Here’s one about the FDA warning letter they received.
- ADIA Labs, who just announced they’ve already opened a stem cell clinic using umbilical cord blood in Winter Park, FL, planning on deploying the stem cells across the country using medical spas (here’s a video breakdown)
- Kwehealth, which manufactures exosomes outside of Gainesville, FL.
- U Miami’s Miller School of Medicine’s Interdisciplinary Stem Cell Institute, founded by Dr. Joshua Hare. They are seemingly already supplying clinical trials with umbilical cord stem cells.
- The various doctors who currently offer PRP, BMAC, and other autologous therapies who would like to try Wharton’s Jelly but don’t want to lose their license. They may have just added another tool to their toolbox, and if they’re a well-run clinic, they’ll have a patient registry to track results. Perhaps in a couple of years, we’ll finally get a side-by-side outcome analysis.
- As a side note, I have upper cervical spine ligament issues, which causes a whole host of other problems. I’ve done PRP 2x and BMAC 2x, which has helped, albeit limited, and still some systemic issues. I’d be very interested if this opens up a new option for me. If I can find a trustworthy lab & clinic, I may give this a limited shot. Will document this on the site if I do.
Given that umbilical stem cell therapy isn’t exactly proven, at least in the traditional clinical trial sense, is the cart before the horse? Yes.
I consider myself a stem cell accelerationist, I personally believe that people suffering at the end of the road should at least be allowed to try things that hold some promise, even if it’s limited. There are millions of people suffering from conditions like pain, neurological issues, autoimmune issues, injuries, and various other conditions with absolutely zero answers from the medical system. Stem cells may be that answer, but it needs to be done in a controlled, safe way by experts, and patients need to be completely aware of the potential risks, outcomes, and current science. With any new medicine, the reality is that we’ll 100% have patients injured, potentially killed. Once that happens, there will be a gigantic scare in the media, and bad news spreads fast. Depending on the net good to bad news ratio, it very well could flop the industry.
I applaud Florida for the move, and hope we finally get some really smart folks on the case to finally explore stem cell therapy.
For an even deeper dive, here’s a video:
