Upbeat prospects for some California clinical trial efforts from CIRM

Over at the California Stem Cell Report, David Jensen is reporting on some good news from CIRM for California on the stem cell clinical trial front.

Stem cell biotechs Asterias and Capricor have stem cell trials supported by 20+ million in CIRM funding each and have been hitting milestones. These trials are progressing and so far have good safety profiles. Asterias and CIRM have mentioned some possibly encouraging early hints at efficacy as well in its trial, and apparently there are hopeful hints from the Capricor trial too.

See the posts from CIRM here (a weekly summary kind of post that begins discussing Asterias) and here. For background, also see past posts I’ve done on both companies here and here in the archives, and see especially my interview with Asterias leadership from a few months back.

It’s early days for these trials and at these phases they are not really designed to look for efficacy so a conservative approach to discussing such trials is in order given the stage, but at this phase of the game for early clinical trials the news has been all one could hope for so far in both cases.

asterias-cells

Asterias cells

The Asterias and Capricor trials are for spinal cord injury and Duchenne muscular dystrophy, respectively. The latter trial utilizes the Capricor CAP-1002 product, which is a cool allogeneic cardiosphere technology made from donor human heart tissue. A beating cardiosphere from a different source (IPSCs) can be seen in the video above. Asterias’ trial employs their OPC product made from hESCs, which is also inherently allogeneic. The idea of potentially repairing the injured spine via stem cells is intriguing.

I’m hoping in the next month or so to do a broader update on the stem cell and regenerative medicine biotech arena. By way of disclosure, I do not have any financial stake in either company discussed here.

Good stem cell news on trials, FDA, cool new papers & more

pericyte-paper

Guimarães-Camboa, et al, Cell Stem Cell figure

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive.

The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile and additional hints at possible positive indicators of efficacy. With the usual, important caveats such as that this is early and it is not an RCT, the SCiStar momentum is positive. I’m excited to see what the future holds for this one including from an RCT. You can read my interview from last month with Asterias leadership here.

I remain very enthusiastic about ViaCyte’s trial as well using a stem cell capsule product for treatment of Diabetes. Their joining forces with BetaLogics a year ago just made their position even stronger.

I’m going to do a post soon on an analysis on the total number of stem cell and regenerative medicine trials compared to historical data I collected. Stay tuned on that. I’m guessing it’ll be good news.

Recently, we also saw evidence of fast action from FDA in response to the 21st Century Cures Act in terms of providing a clear document on Regenerative Advanced Therapy designations and applications. It’s still unclear how the Cures stem cell provisions will play out, but I consider quick, clear action from the FDA to be a positive. I wish they were this fast on other stuff like dealing with stem cell clinics marketing unapproved drug products.

There have been a number of cool papers recently that I recommend reading:

List of 11 stem cell good news or interesting stories

stem cells autism

UPI photo

Need a fix of some stem cell good news? I do.

It has been a bumpy 2016 so far for the stem cell field and many challenges have popped up.

So today at lunch and needing at least a short break from grant writing,  I went looking for stem cell good news including interesting studies, promising trials, and frankly things that just sound unusual or even weird.

I’ve listed these below.

Have a good weekend…you know what I’ll be doing: working on my grant.

If you know of other stem cell good news pass it along in the comments.

Researchers Develop 2D ‘Eye’ From Induced Pluripotent Stem Cells

Scientists find new stem cell target for regenerating aging muscles (by Karen Ring at the CIRM Blog)

San Diego gets new stem cell center

Stem cell modeling of autism.

Induced Microglia Make Debut at Keystone Symposium

Stem cell research aims to put an end to root canals (I went looking for actual data on this story has generated massive buzz, but couldn’t find any…so far. Unpublished but coming?)

Tattoo treatment could boost stem cell research

Continue reading

What are the top recent stem cell good news stories?

Sometimes there is so much craziness and outright bad stuff going on out there around the world related to stem cells that we can lose sight of all the good and encouraging developments as well.

I think the new paper (Chen, et al.) from a team led by Drs. Lane and Loring is good news.

I haven’t had time to fully read it yet, but it reports some encouraging results whereby human neural progenitors injected into the spine of mice with an experimental MS-like condition stimulated great clinical improvement. The cells seemed to reduce inflammation although they did not appear to engraft.

What do you see as the most promising positive developments on stem cells lately?

Let us know in the comments.

After nightmare stem cell week, some good news?

Nightmare

We in the stem cell field should call this past week

A Nightmare on Stem Street.

I can’t think of many weeks that have been worse for the stem cell field than this past one. I’m a new week is starting soon.

It was a real nightmare, although I wish it was just something fictional out of the movies (see movie poster from Wikipedia). What happened?

  • The STAP horror fest kicked it up a notch in providing pain to the stem cell field with a dramatic press conference from Dr. Obokata in Japan that was a toxic stew. More STAP press conferences are apparently coming….
  • Brigham and Women’s Hospital and Harvard Medical School took a stem cell hit with a paper retracted (by request from Harvard) from the outstanding journal Circulation. This paper from cardiologist Dr. Piero Anversa had claimed against all odds/previous data that the heart could quickly repair itself.
  • A second shot to the heart for the stem cell field came again from Brigham and Women’s Hospital and Harvard Medical School, as they face another burgeoning stem cell paper fiasco. The Editors of The Lancet published an expression of concern about another stem cell paper from Anversa.
  • And there was yet another high profile stem cell paper retraction, this time from Cell, was announcedThe compromised paper “Directed Conversion of Alzheimer’s Disease Patient Skin Fibroblasts into Functional Neurons” had reported some interesting direct reprogramming, but one author, Dr. Ryousuke Fujita, has reportedly fessed up to some serious shenanigans on the data. The retraction was at the request of the authors.
  • Finally, NIH CRM is finished. Finally, the chilling cherry on top of the stem cell week from hell was the news that NIH’s stem cell program, the Center for Regenerative Medicine (CRM) was closing up shop after only having funded one grant. Terrible news.

So how about some good stem cell news?

Any other stem cell good news recently?