Regenerative Medicine and Stem Cells Technologies

What will be the big developments in the stem cell and regenerative medicine field in 2018? Below are the top 20 predictions in no particular order. As usual, there is a combination of science and news/policy predictions.

1. Combo cell-gene therapy continues hot, but with both ups and downs. Combination cell-gene therapy makes more big news including probably additional FDA RMATs here and possibly 1 more drug approval. Some of this could be CAR-T stuff, but probably other work too in this area such as 2017’s epidermal regeneration. Hopefully more ups than downs.
2. At least 20 total FDA RMATs. The FDA continues issuing a steady stream of RMATs getting to a total of 20 or probably more (including those issued in 2017.) Does a dubious stem cell clinic-related biz get one in 2018? Possibly, but if so, I’d bet no more than one such firm and it has an IND first.
3. More IPSC movement in Japan. More IPS cell regenerative medicine progress in Japan including 1 new clinical trial/study beyond Masayo Takahashi’s work.
4. IPSC step forward in USA too. A major step forward for IPS cell clinical trial efforts in the U.S., probably at least 1 notable IND.
5. In utero experimental interventions make news. There is a lot of interest in having impact on developing fetuses during pregnancy including via stem cells. At least 1 high-profile study or news development
6. ESCR in USA funding stays OK. Assuming Trump is still president throughout 2018 and not Pence, we do not see any concrete restrictions (no new federal law or Presidential action) on embryonic stem cell research (ESCR) in the U.S. Trump just doesn’t personally care about it and Pence has little influence on social issues with him.
7. CRISPR human embryo news. More big new CRISPR human embryo news and/or pubs including at least 1 more “knockout” paper in viable human embryos, probably from Fredrik Lanner’s lab (see interview here). More from Kathy Niakan? See my review of her CRISPR OCT4 knockout human embryo work here.
8. Parkinson’s Disease advance. A major step forward on stem cell-based therapies for PD, possibly including 1 IND.
9. Dubious clinics’ MSM ads continue to flow. The trend of mainstream media ads for stem cell clinics continues in a big way. Anyone seen TV commercials yet?
10. Ma, et al. human embryo CRISPR pub arguments: limbo at best. The main conclusions of that Mitalipov lab Ma Nature paper on interhomologue repair in human embryos with CRISPR are not conclusively confirmed. They remain at best in limbo throughout most or all of 2018.
11. Clearer CIRM path to 2020 effort. CIRM supporters firm up plans for a new California state proposition effort for 2020, which probably includes a continued plan for an initiative for more funding.
12. At least one state steps up on dubious clinics. At least one state takes legal action on stem cell clinics in its borders. This could be a medical board or some other state governmental body.
13. Some unusual FDA action on dubious clinics. The FDA issues more than 1 warning letter to dubious stem cell clinics and/or takes some other bold action in 2018 such as an injunction or some other strong step that clearly breaks with what it’s done in the past.
14. Other Feds step in too. Some other federal body takes an interest in dubious stem cell clinics.
15. More patients sue. One or more new patient lawsuits against direct-to-consumer stem cell clinics.
16. Clinic strikes back, threatens suit. At least one clinic selling non-FDA approved stem cells threatens to (or does) sue a regulator, a patient, or other critic. We saw one such threat in the news in 2017 and there were more behind the scenes too in 2017 too.
17. Florida stem cell hot mess. The stem cell mess in Florida continues to heat up. Even though California has more clinics, Florida probably makes more news with problems.
18. Clinic leaks. An insider at a direct-to-consumer stem cell clinic leaks information or documents that aren’t flattering for the biz, or somehow such info comes to light, perhaps via a lawsuit.
19. A biotech gets a boost, but the bummer is that overall stem cell biotech stocks continue to struggle. As to the former, a well-known stem cell-related biotech is either acquired or has an IPO.
20. Anti-aging efforts spark more news and controversy. This could be young blood, specific anti-aging stem cell-related factors, and/or actual stem cells.

Reference: https://ipscell.com/2017/12/top-20-predictions-stem-cells-regenerative-medicine-2018/