Top 20 Stem Cell Predictions for 2017

stem cell crystal ball

Stem cell crystal ball

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.

What will 2017 bring? Below are my top 20 predictions in no particular order except starting with a few hopeful visions for the coming year.

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About that Athersys stem cell stroke clinic trial PR…

AthersysThere has been a lot of excitement this week about a press release from stem cell biotech Athersys that reported that treatment of stroke patients with its product MultiStem was associated with a statistically significant improvement at 1-year.

This sounds encouraging and the stock has spiked up as a result.

However, there are some naysayers including long-time stem cell biotech critic Adam Feuerstein, who today painted the Athersys press release as little more than spin.

Feuerstein went through a list of what he describes as negative clinical trial results for MultiStem, particularly at earlier time points after stroke. For instance, he asks essentially, “how could MultiStem fail to help paints earlier in the recovery phase and then suddenly help them at 1-year?” His answer is that it couldn’t and he compares the stem cell product as well as its reported positive results at 1-year to the Titanic in some biting analogies.

I feel like I need to dig more into the this before having a good sense of what the real deal is here. By the way I’m no fan of Adam’s and for some unknown reason he still has me blocked on Twitter.

What do you all think about this Athersys press release and the prospects for the company? If you disagree with Feuerstein, why is he wrong?

What is the top stem cell biotech of 2014? Take our poll

What is the most exciting, important, promising, all-around awesome stem cell biotech of 2014? Vote and tell us why in the comments.

Top 10 questions for stem cell field bouncing around on a Friday morning

top ten listWhat are the most interesting questions for the stem cell field in 2014 right now?

What’s on your mind?

I’m not going to give this deep thought, but rather just list those questions bouncing around at the moment in no particular order. You can see a lot of translational/clinical things are on my mind. I’ve put possible answers, but these are highly speculative and/or based on hope in some cases.

  • What’s next for ACT’s hESC-based clinical trials and Takahashi’s iPS cell-based clinical study for macular degeneration? I’m optimistic on safety for ACT and hopeful on efficacy, while it’s harder to predict for the iPS cell study.
  • How will ViaCyte’s new early hESC-based trial for Diabetes go? I’m cautiously optimistic.
  • In a year, where will the iPS cell IP/patent arena stand and who is BioGatekeeper? I expect no more clarity in a year overall, but BioGatekeeper will be outed by then or much sooner.
  • Will the trend of for-profit networks of stem cell clinics exploding across America continue? Unfortunately, yes.
  • Is the FDA planning to get back into the ballgame of regulating such stem cell clinics or has it punted due to (fill in the blank: budget problems at the agency, other priorities, a change of philosophy, etc.) Who knows? It’s been a disappointing year for the agency in this area.
  • Will the FDA apply Fast Track, Accelerated or Priority Review or Breakthrough Therapy Designation to any emerging stem cell products? It’s about time. They should.
  • What will the impact of the likely growing number of state Right To Try laws be? I expect it will increase both risk and innovation, but unfortunately much more of the former than the latter.
  • Was the flood of very high profile stem cell paper retractions so far in 2014 an aberration or will it painfully continue? I hope it does continue, but it’s a worry as the field needs public trust and respect.
  • Will a big pharma acquire a small biotech like Athersys, ACT, StemCells, Inc., Neostem, in the coming year? More money is sure flowing from big to small (witness ViaCyte’s new influx of money) and we saw this with happen California Stem Cell. I think we’ll see this trend of money flow or even acquisitions accelerate although there are structural obstacles to being acquired for certain companies.

What questions are on your mind right at the moment related to stem cells and regenerative medicine?

Note this post is simply informational and is not financial advice. Only make financial decisions after consulting with a certified financial planner, which I am definite not. I hold no stake in any of the companies mentioned.

Book Excerpt: Top 4 Stem Cell For-Profit Good Citizen Biotechs

The below is an excerpt from my book, Stem Cells: An Insider’s Guide.

I hope you enjoy this excerpt and the book, which I think is a really good deal at under $27 paperback or under $17 for E-book version.

Having our innovation and ethics too

In the stem cell field you can have it both ways. As a company, you can be ethical and help patients. There are many examples of stem cell-related corporations doing “the right thing” when it comes to developing therapies based on growing stem cells in the lab. Below I discuss a few of these companies (Disclosure: I have no financial interests in these companies, which are listed in alphabetical order).

Advanced Cell Technology

As one example, let me mention a company called “Advanced Cell Technology” or ACT. I would argue that, especially in the last half dozen or so years, the company has been a model citizen in the for-profit stem cell field.ACTC

ACT’s most advanced product in the pipeline toward the clinic is an embryonic stem cell-based therapy for macular degeneration, the leading cause of blindness. ACT grows the embryonic stem cells in culture and differentiates them through a complex process into special cells called retinal pigmented epithelial cells (RPEs). Macular degeneration robs people of their sight because their endogenous RPEs die off. Therefore, the principle behind ACT’s therapy is to replace the endogenous RPEs with exogenous ones. So far, ACT has reported no major negative outcomes from its trials of transplants of embryonic stem cell produced-RPE. I am discussing ACT here because it follows FDA rules and works in an ethical manner to protect patients. It publishes its data and engages patients.

Athersys

Athersys is an adult stem cell company developing allogeneic products to treat a number of important human diseases. The company has five clinical trials listed in the government database. AthersysThe target diseases include stroke, heart attack, blood cancers, obesity, and ulcerative colitis. Their top-line product, MultiStem, is described by the company in one of their clinical trial write-ups as follows:

“MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing.”

Athersys has a good reputation in the stem cell field for transparency including regularly publishing their data and following FDA regulations.

Mesoblast

Mesoblast is another good citizen in the stem cell field and has an unusually large number of stem cell products in the pipeline. Their work is based on a type of cell that they call the “Mesenchymal Progenitor Cell” or MPC. Interestingly, while typically progenitor cells have less potency than stem cells, as we discussed earlier in this book, Mesoblast’s MPCs are not your ordinary progenitor cells. 

Mesoblast_Ltd

I recently heard a talk by Dr. Paul Simmons of Mesoblast who reported that MPCs are in fact more potent than MSCs, which is an interesting paradox of nomenclature. Mesoblast is conducting FDA-approved clinical trials for a host of human diseases. I found 9 clinical trials listed for Mesoblast including for conditions as variable as spinal disc injury and heart attacks.

NeuralStem

NeuralStem is a fourth good citizen in the stem cell for-profit world. They are a model citizen for the field when it comes to transparency says Alexey, who I trust on this a great deal, publishing data and even publicly releasing their patient consent form, a rarity in the stem cell field. NeuralStem currently has four clinical trials listed in the database: two on depression, one on spinal cord injury, and one on Amyotrophic Lateral Sclerosis (ALS; Lou Gehrig’s Disease).NeuralStem

The key, positive roles of investors in good-citizen companies

It is important to also highlight the crucial role of investors in making safe, effective, ethical, and compliant stem cell treatments a reality. For-profit stem cell companies including the good citizens of the corporate stem cell world need large amounts of cash to make stem cell-based medicine a reality.

The money comes from investors, who are hoping that some of the exciting stem cell biotech companies become profitable. I know from talking with many of the investors that they are choosing to invest in the stem cell companies not just because they believe that they will be profitable, but also because the stem cell products of those companies will potentially help people suffering from diseases and injuries. I believe that the investors in publicly traded stem cell companies fulfill a key role in accelerating stem cell cures. They tend to be a highly educated, engaged group of people as evidenced by their posts on a website for stem cell investors where I sometimes blog as well.

Investors in privately owned companies can also have positive roles, but I am concerned that in that context the lack of transparency may lead to a more complex, potentially ethically problematic influence.

The main overall challenge in a for-profit setting is to create a business regulatory environment in the stem cell field that enables good actors to succeed.