20 stem cell & regenerative medicine predictions for 2019

For a long time at the end of each year, I’ve been making stem cell predictions for the coming year. Most often I’ve been making a “top 20” list of predictions and today’s post has my list for 2019.

You can see how I did for 2018 here, which might have been my best year ever for predictions. We’ll see if I can match that here for 2019. I doubt it. However, I do think my prediction that 2019 will be the worst year ever for snake oil stem cell clinics will be spot on.

I make these prognostications based not on a stem cell crystal ball (although I like to joke about that) but rather via a combination of information found both inside and outside the public domain. It generally ends up substantially better than a coin toss in terms of outcomes.

Here’s the list of predictions for 2019. As usual it’s a mix of expected upbeat and bad news. Some predictions are combinations of related predictions.

1. Organoids. The upper size limit of organoids such as brain organoids will continue to grow as vascularization and other related work moves forward. This advance will enable more cool research, but keep raising tough ethical questions too related to this so-called human “mini brains”. The recent report of fetal human brain wave-like activity in organoids is relevant here.
2. Parkinson’s Disease. More concrete reasons for hope on clinical stem cell clinical for Parkinson’s Disease. The news of the 1st patient transplanted in Japan via an IPS cell-based product in 2018 is encouraging. Not a prediction exactly, but I’m hoping to see more IPS cell good news, possibly on PD, in the US too.
3. Two biotechs on the move. Some major twist for the stem cell biotech ViaCyte including not just science-wise, but also or instead potentially talk of an IPO or an acquisition. Most likely this is good news. I hope! A second biotech, Athersys, has some much-needed good news. Further, unfortunately, on the whole the stem cell biotech arena doesn’t do great in 2019.
4. Trump-Pence. The Trump administration (including most likely VP Pence) at least talks about restrictions on embryonic stem cell research. I hope this doesn’t get ugly.
5. CIRM. A formal announcement of either a 2020 state proposition for more funding for the California Stem Cell Agency, CIRM, or a major private philanthropy plan.
6. CRISPR babies A. Two opposing developments.  Supposed claims of independent confirmation that the CRISPR baby guy He Jiankui did make mutations in human babies (e.g. an independent lab such as George Church’s analyzes the sequencing data), but probably also news that He didn’t actually make the mutations he said in the twins. Confusing, right? Unclear if anyone including the Chinese government will have access to independently (and ethically) sample the twins and parents for their own analysis of the data for real confirmation.
7. CRISPR babies B.The Chinese government will announce some kind of punitive action against He Jiankui. Could it end up being too harsh or just largely symbolic?
8. The FTC will take some further action on one or more stem cell firms in the US.
9. The FDA will issue at least 3 warning letters to stem cell businesses in 2019. It’ll do more on other stem cell fronts too I’m guessing.
10. State Medical Boards. One or more state medical boards will make news on action on stem cell clinics (I’m hoping including here in my state of California). The recent news of a California Medical Board task force makes this more likely.
11. State Attorney Generals. At least one state Attorney General office will take legal action on stem cell clinics. It could even be two. There may also be local law enforcement action on stem cell clinics.
12. State law. At least one more state will have a bill emerge related to stem cell clinics, possibly Florida again.
13. Two big federal court cases. The FDA will win the initial rulings in its lawsuits against U.S. Stem Cell (USRM) and Cell Surgical Network/California Stem Cell Treatment Center. It’s possible that both the cases won’t be entirely resolved by year’s end though, pending appeals.
14. U.S. Stem Cell metamorphosis. Despite the appeals in the suits mentioned above in prediction 15, USRM will undergo a dramatic change most likely involving either no longer being a U.S. publicly traded stock/FEC action, moving a sizable chunk of its focus overseas (maybe mostly in the Middle East), or shifting away from fat products. I’m not formally predicting this, but it’s also possible that in the next 12-24 months USRM may no longer exist.
15. Cell Surgical Network 2019 predictions. This clinic chain will exhibit shrinkage of its affiliates or other related negative news. They could also move a chunk of their work overseas.
16. Stemgenex. The proposed class action suit against Stemgenex either gets its class status or continues to heat up.
17. Bad actor chiropractors. At least one and probably more chiropractors find themselves on the hot seat because of their stem cell business, potentially facing criminal action or temporary loss of their licenses.
18. Birth-related “stem cell” products & clinics take a hit. The unproven birth-related (amniotic, placental, umbilical, Wharton’s jelly) unproven clinic and supplier arena, intimately tied to chiropractor firms, finds itself in more hot water. I don’t think it’s a good year for supplier Liveyon.
19. Exosome hype. More clinics sell sketchy unproven, non-FDA approved exosome therapies.
20. Multiple sclerosis (MS). Ending on a more positive note, more encouraging news on the legit front of stem cells for multiple sclerosis (MS) most likely via HSCT combined with some kind of immunoablation. Many of us are eagerly awaiting a new paper on this front in 2019.