Each year towards the end of December I make predictions for the coming year as I did for 2015. In the past I usually make a top 10 prediction list, but for this year I made 20 predictions. Admittedly some of them may have been more hopes than predictions.
At mid-year today on June 30th, how am I doing? See below. Note that of course for some the jury is still out.
BTW, stay tuned for more on an upcoming update on the Japan IPSC macular degeneration trial where there seems to have been a (hopefully minor) hitch.
- FDA ‘breakthrough’ on stem cells. FDA grants an investigational stem cell biological drug therapy the breakthrough status designation. Status: so far no luck, but still hoping.
- Adult & pluripotent stem cell advances both impress. More encouraging publications and news on the clinical and translational fronts for both pluripotent and adult stem cell drug development including MSCs. Status: Definitely correct.
- Doc training in stem cells. More new academic-related training programs for doctors to be true stem cell and regenerative medicine specialists. Status: so far no luck, but still hoping.
- Big pharma’s big interest in stem cells grows further. Big pharma’s interest in stem cells & regenerative medicine continues to grow including at least one major development that might be takeover of a stem cell biotech or something else. That are some small stem cell biotechs that seem ripe as takeover targets. Status: Mixed bag. Both some positive and some negative signs on this.
- RTT spread. At least one more state (and probably more) pass Right To Try (RTT) laws setting up a collision course between state and federal laws on investigational drugs including stem cell products. Status: Definitely correct. Tons of states moving on RTT.
- Pro sports gets a bit more serious about dubious stem cell “treatments”. A pro sport players association or league acknowledges growing and difficult stem cell issues for players. Status: Mixed bag.
- More high-profile stem cell paper problems. At least one and probably more major stem cell paper problems pop up and could include retractions. Status: Yes, unfortunately (just see Retraction Watch on stem cells)
- The UK Parliament OKs 3-parent baby tech. The parliament approves 3-parent/mitochondrial transfer technology, but more steps are required before it is practiced in humans. Status: Correct
- Stem cell clinic chains Cell Surgical Network and Stem.md continue to grow for at least the first half of 2015 and probably beyond. They operationally challenge recent FDA draft guidances on adipose and minimal manipulation. Status: Correct
- STAP-related news on the American front. We learn something on the US side of the story of the retracted STAP cell Nature papers. Status: Not yet, but stay tuned.
- Muddier stem cell waters. More mixing of “legit” stem cell companies and researchers with the non-compliant side of the tracks. Status: Unfortunately correct
- More stem cell paper debates and developments on PubPeer. A volatile situation continues with notable twists and turns. Status: Yep.
- IPSC RPE safety. The IPSC-based RPE trial for wet AMD in Japan continues in 2015 without a reported safety hitch. Status: Probably Wrong (again stay tuned, but don’t freak out).
- A stem cell biotech finds itself in a hairy situation. What a tangle. Status: stay tuned.
- At least one patient is harmed or files suit for a dubious stem cell clinic treatment. This is a sad prediction, but unfortunately I think it is likely. Status: publicly not yet.
- VSEL hell. There will be even more bad news for these Sasquatch of stem cells after the Weissman lab paper that seemed to refute these “very small embryonic-like” stem cells in 2013. What does this mean for NeoStem ($NBS) now known as Caladrius? Status: Nothing public yet, but I still expect it to be a bad year for VSELs. For Caladrius, I’m thinking the impact is minimal since their focus seems elsewhere under new leadership.
- Celltex is going for an IND. This is an interesting development. Status: not publicly.
- GOP on stem cells. Republications make some noise on stem cells or personhood. Status: not yet, but they are on CRISPR as my old soccer coach would say when I was a kid “like a duck on a june bug”.
- FDA back in the game of taking action on dubious stem cell clinics. After a long quiet period in 2014, the FDA takes some action on dubious stem cell clinics. Status: depressingly, not yet.
- Stem cell-based organs. The red-hot trend of bioengineering organs and tissues in part using stem cells as a material continues to develop. Status: Yes, organs and organoids are one of the hottest trends of 2015.