Stem Cell Blog Reader Survey, Free Swag

stem cell t-shirtEvery few years I do a survey of you guys so I can have a better sense of my blog’s readership. For that purpose, below I’ve got two polls to ask you (1) about your general backgrounds and (2) preferences about post content.

Because some people may want to vote more than once on the types of posts they like the most, I’ve allowed re-voting on that poll.

Free stuff? Those who participate and leave a comment or email me to indicate they did (knoepflerATucdavisDOTedu) will be entered in a drawing for one bundle of free swag: a stem cell t-shirt and signed copies of my two books.

New Yamanaka interview gives key insights into future of IPS cells

Shinya yamanaka

Wikipedia photo

Where is the field of IPS cells going and how will this impact the overall field of stem cell-based regenerative medicine?

Nobel Laureate Shinya Yamanaka, the discoverer of IPS cells, gave a really interesting recent interview to Nikkei that provides some fascinating insights into the future of this exciting technology that is now more than a decade old.

For simplicity I have indicated top highlights from the Yamanaka interview below as bullet points.

  • More IPS cell trials are on track to start as soon as 2018 in Japan.
  • Yamanaka said that trials for Parkinson’s, Spinal Cord Injury, and Heart Disease are amongst the planned IPS cell trials in Japan.
  • There are also plans for clinical studies on cancer and kidney disease, perhaps further down the road such as 2019-2020?
  • Immune rejection and cancer risks must still be evaluated, he said.
  • There are likely to be important differences in the new studies versus use in the eye.
  • CiRA has started working with Takara on QC of IPS cells and products.
  • Their main focus for all these trials still seems on allogeneic use from IPS cell banks.

It will be interesting to see how trials in Japan develop versus those in other countries such as here in the US where I know of planned autologous IPS cell clinic efforts.

3 Dangerous Texas Bills Would Boost Stem Cell Clinics

Texit stem cells

The Calexit and Texit state secession campaigns for California and Texas to leave the union, which are linked to Russian President Putin, are never going to be successful. However, if some Texas lawmakers and stem cell clinics there have their way, Texas would take a big step away from the rest of us on the stem cell front, endangering patients. Such a development would strongly contrast to all the great, cutting edge stem cell research going on in labs across that state. Somehow this major development has not been covered yet by national or even Texas media.

What’s the scoop?

Three bills are pending at the Texas Capitol that if passed and signed into law would pave the way for unproven, risky stem cell therapies to be sold much more readily to patients by clinics. The Texas stem cell bills include HB 661 and HB 810 by Rep. Tan Parker, and HB 3236 by Kyle Kacal. You can learn more about the bills by following direct links to each bill here, here, and here.

HB 661 seems to be a very loose kind of right to try effort that concerningly would extend it from restricted just to patients with terminal illnesses to also those with chronic conditions that could be just about anything. In a sense, a stem cell clinic’s own doctor perhaps could decide whether their patient/customer has a chronic disease that is eligible. How often would the clinic doctor say “no” since that would mean the patient would not get the treatment and so would not pay them big bucks?

Stem cell cartoon

HB 810 is a stem cell-specific kind of right to try bill that would greatly lower oversight standards and put patients at greater risks. The third bill, HB 3236, is what I call “Right to Profit” for the clinics because if that bill passes then the clinics would have free rein to make millions in profits from vulnerable patients. How would that be a good thing for most Texans? It wouldn’t. In fact, I see it as a consumer ripoff bill.

Other than stem cell clinics, it’s hard imagine many fans of these bills. Most people I have talked to strongly oppose them including top stem cell scientists in Texas. The organization Texans for Cures, which has been very balanced, sensible and supportive of stem cell-based regenerative medicine for many years, strongly opposes these bills too. Here’s a statement from its Chairman David Bales:

“After careful examination of HB 661, HB 810 by Rep. Parker and HB 3236 by Texans for Cures Medical Advisory Committee, which includes leaders like Dr. Doris Taylor and Dr. William Decker, we decided to vigorously oppose all three bills because they jeopardize patient safety and responsible research in the State of Texas”.

There’s broader opposition too. For instance, the largest global stem cell research organization, ISSCR, is opposed to these stem cell bills. You can read more about ISSCR’s viewpoints in a letter from its President Sally Temple to Texas lawmaker Todd Hunter. Here’s a big picture quote from the ISSCR letter:

“…these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”

What businesses exactly would stand to benefit mostly at the expense of patients? Continue reading

What is hardest thing we do with our brains in a lifetime?

brainatwork

Wikimedia open image

What’s the hardest thing we ever do with our brains on average during a lifetime?

Our brains are wonderful things that some have called the most complicated structures in the known universe, but what exactly do we do with them? Do we tax them fully during our lives?

The old cliché that we only use 1% of our brain or some approximation thereof is malarkey in my view, but how hard is it for the average person’s brain to watch a boring YouTube video? Not very. On the flip side, what do we do with our brains that is incredibly hard? The hardest thing for the average person in their life? Continue reading

Big change for stem cell field with FDA quickly issuing RMATs

The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation.

I don’t think anyone was sure how this would play out in terms of how quickly the FDA would give RMAT designations and to how many investigational products. Already it’s clear the FDA seems to be embracing the spirit of the Cures provisions as it has given out quite a few FDA granted RMAT designations and done so quickly.

The first that I could see was given to Humacyte, which has an artificial vessel research program (see image). The artificial vessels become colonized with endogenous stem cells after implantation.Humacyte

Keep in mind that RMAT designation does not equal FDA-approval overall, but it should mean the investigational therapy has solid data behind it and is promising, together equaling a faster FDA review and then potentially in the future approval should future data be strong. If some of the RMAT therapies are ultimately proven to be safe and effective, and via RMAT they were able to get to patients and help them more quickly, with few failures amongst the RMAT group, then the RMAT regulatory experiment will be proven a big success.

Here are the approved RMATs I could find so far:

  • Humacyte (Vascular Access for Hemodialysis)
  • Enzyvant (DiGeorge syndrome)
  • jCyte (Retinitis Pigmentosa)

There may be more already given, but not yet in the public domain. If you know of others please comment on the post to let us know and I’ll add them.