In December of each year I make a list of stem cell predictions for the coming year, and I made 20 such predictions for 2017 so I’m wondering how I’m doing so far on these now that it’s June. Below is my work-in-progress scorecard for these so far.
Positive news from Asterias on trial for stem cell-based therapy for spinal cord injury. Status: Correct, trial looking encouraging.
Upbeat news from ViaCyte on stem cell-based therapy trial for diabetes. Status: Correct, raising $10M and things looking promising.
More positive news from the old Ocata now under Astellas umbrella on trial use of stem cell-derived RPE for Macular Degeneration. Status: Not Yet.
Good news on the adult stem cell front on trials for one or more major diseases. At least one and probably more positive developments here. Status: Correct, lots of good news. The potential for stem cell generated blood is just one example.
Fake news hits stem cell arena. Stem cell clinics use fake news. For instance, this might be a media mouthpiece for one or more stem cell clinics actively using fake news-like approaches to promote them. Status: Correct, unfortunately.
More clarity on clinics: data. More academic publications on the practices and outcomes of stem cell clinics are published, bringing greater clarity to what is going on with actual data. Status: Not Yet.
More lawsuits against stem cell clinics. There has been a lot of buzz on this behind the scenes already and cases popping up in 2016. This is going to grow in 2017. Status: Not Yet.
Concrete clinic harms. We learn more about additional examples of patient who feel they’ve been harmed by American stem cell clinics including in particular alleged clinic-caused blindness. Status: Not Yet.
Some other federal agency besides the FDA makes news on stem cells. This may not be until 2018, but we’ll see. Status: Not Yet.
At least one FDA guidance is finalized. The FDA finalizes at least one of its four recent stem cell-related guidances, but probably not all four. Status: Not Yet.
More than one warning letter. The FDA issues more than one warning letter to stem cell clinics in this year. Will it still be a drop in the bucket or some kind of decisive action? The FDA may have more difficulty taking action within the Trump context and much will depend on who is the new Commissioner. Status: None Yet.
Japan IPSC trial starts. Great news as at least one IPSC trial begins in Japan. Maybe two. Status: Correct.
Cures yields regen med IND. The FDA takes at least one accelerated stem cell-related IND action traceable to the Cures Act related to a promising new stem cell/regenerative medicine therapy. Hopefully no direct to consumer businesses try to tap in. Status: Looking correct based on many RMATs granted.
Athersys, Cytori, and Mesoblast have some ups & downs amongst them. Status: Correct.
Prop 71 2.0. CIRM and/or Prop 71 supporters start more openly talking about a new round of CIRM funding. This may include mention of Trump as problematic for the stem cell field and the continuing need for California to take the lead. . Status: Correct. Will they pull the trigger though this year?
Trump somewhat, but not entirely limits ES cell funding. The Trump administration probably does not outright ban federal funding of embryonic stem cell research, but there may be some effort to limit it in some way such as not supporting generation of new lines perhaps à la Bush. Status: Not yet.
Fetal tissue research restriction effort. The Trump administration and/or the GOP attempt to restrict human fetal tissue research. Status: Not yet.
CRISPR of human embryos is blocked or limited in some way in the U.S. (e.g. FDA is not permitted to review applications related to this area as was the case with the rider on spending bill for 2016). Status: Not yet.
Trump creates something like Bush’s President’s Council on Bioethics. It’s packed with conservatives including someone tied to the Witherspoon Institute. Deja vu all over again. Status: Not yet.
Florida acts on clinics. The state of Florida takes some action on stem cell clinics, which are out of control there. Things are a mess clinic wise here in California too, but I’m not so sure the state will do anything helpful to deal with it. Status: Not yet.
Overall, I’m doing OK so far, but much is up in the air for the final 6 months of the year.
I’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive.
I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or email me. Ideally, you would indicate if you have an investment in these stocks for the publicly-traded ones. Don’t restrict yourself only to stocks traded on US markets necessarily and private companies like ViaCyte are exciting as well so should be included.
It’s also interest to see how these lists change over time reflecting shifts and trends in the industry. For instance, Ocala (fka as ACT) is gone. StemCells, Inc. is gone. CDI is gone as an independent entity at least.
Look for a future post with a stem cell/regenerative medicine biotech list. If you invest in this sector be aware it is extremely risky and over the years most of these kinds of stocks have tended to go down more than up.
Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.
You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.
Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong.
Overall, I did better than most past years with only having entirely blown it on four.
Stay tuned later this week for my 2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine.
The Score Card on 2016 Predictions
Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Grade: Some acquisitions, but not huge news.
Charging patients for clinical trial participation, particularly in Japan due to the new policy and here in the US related to predatory clinics remains a hot topic. Grade: Correct.
Stem cell clinics and doping in sports flares up more. Grade: not really the two together.
Organoids continue to excite. Grade: Correct.
Bioheart and some other small stem cell companies struggle. Grade: Correct.
Stem cell stocks overall have a bad year. Grade: Unfortunately, generally correct.
Stem cell clinics ever more aggressively use celeb clients for PR and marketing. Why? It is powerful, effective, and essentially free advertising. Grade: Correct.
More news on human-animal chimeras. Grade: Correct.
FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Grade: Sadly correct.
Pressure from industry and some academics on FDA to not regulate adipose products as drugs and/or to not enforce some other draft guidances including at the public hearing on the draft guidances. Grade: Correct.
FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Grade: Correct.
One or more lawsuits against a stem cell clinic. Grade: Correct in a big way. E.g. versus U.S. Stem Cell, Lung Institute, and Stemgenex.
A new stem cell scandal pops up related to publication issues. Grade: Correct. You just have to go visit Retraction Watch (e.g. the Spain mess), For Better Science, or PubPeer, and then also see the continuing Macchiarini debacle in particular.
Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Grade: Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention.Remarkably, nevertheless UK folks are going forward with it in humans anyway.
The trend last year of increasingly blurred lines between legit research entities such as universities and dubious stem cell enterprises continues. This is worrisome. Grade: Correct. For instance, see Rasko paper.
Stem cell-derived human germ cells stay in the headlines. This has exciting potential for providing new windows into human development and tackling infertility, but also raises thorny issues such as human genetic modification. Grade: Correct.
ViaCyte has some big news. Grade: Not yet…
High-profile developments on veterinary use of stem cells. Grade: Correct.
Animal cloning, particularly in China, continues to proliferate. Grade: Correct.
More rumblings on possible human reproductive cloning attempts. Grade:Some here and there, but not much.See this pieceon cloning focusing on 20th Anniversary of Dolly.
CIRM announced recently the funding of a number of exciting new studies.
ViaCyte received additional funding to support its development of its hESC-based pancreatic progenitor cell product PEC-Direct clinic trials. This work is very promising. CIRM also funded additional diabetes-related research by Humacyte on engineering blood vessels for use in dialysis, which is very creative.
I was happy to see that my colleague here at UC Davis School of Medicine, Professor David Segal, received funding for a cutting edge grant on using gene editing for Angolan Syndrome. The grant is entitled, “MSC delivery of an artificial transcription factor to the brain as a treatment for Angelman Syndrome”.
This funding along with a new grant for Jeanne Loring on stem cells for Parkinson’s came via CIRM’s new basic biology type of funding mechanism. A number of other cool projects got funded via this RFA including one by David Schaeffer at Berkeley on stem cell-produced oligodendrocyte precursor cells to treat neurological injury.
This all is very good news for the stem cell field.