A new stem cell cosmetic cream, Stemáge, being pitched by former super model Kathy Ireland in YouTube commercials has made a number of claims.

They have also used suggestive language that they (or their apparently affiliated company Scharp Technologies) were collaborating with what is, in my opinion, one of the best research institutions in the world: Sanford-Burnham.

I have now got an official response from Sanford-Burnham regarding the company selling Stemáge stem cell anti-aging.

I heard from Deborah Robison, VP of Communications as follows:

“Sanford-Burnham is not collaborating with Stemage, has no relationship with the company, and has no involvement with the product or any commercial aspects.  The verbiage on the Stemage website was not approved by Sanford-Burnham.  Sanford-Burnham provides no endorsements with regard to commercial products.

Sanford-Burnham has a corporate sponsored research agreement with Sharp Technologies, Inc.; through the agreement Sharp Technologies provided stem cell material to the Institute and information regarding the biology of the stem cell activity is being shared with Sharp Technologies.”

I am attempting to find a way to contact Stemáge and Scharp Technologies for comment.

Today it is commenter Natalie DeWitt (see my earlier interview with her about her experiences at Nature’s The Niche) who has contributed a particularly insightful, knowledgable comment on my recent perspective piece the Cell cloning paper mishap.

Many in the stem cell field and beyond have been unsure how to take the news of the problems with the Mitalipov cloning paper in Cell.

Are these issues a big deal or not so much?

DeWitt provides some much needed historical context and wisdom for thinking about the Cell cloning paper mess:

Updated (May 23): note that preliminary word from Sanford-Burnham is that they are not collaborating on Stemáge.

I was alerted by a friend to the fact that there are now YouTube ads for stem cell products popping up.

One such ad features supermodel Kathy Ireland pitching for something called Stemáge Skin Care.

Today’s post is Part 1 of at least 2 on this Stemáge product.

I will post Part 2 soon that is a must read as it includes information my somewhat shocking phone conversation with a representative of the company regarding where they obtain the stem cells for Stemáge and more.

Why is a human stem cell-based cosmetic cream important?

Such a product can be considered a medical product subject to regulation by the FDA and the FDA also oversees the efficacy or safety claims made by sellers of such products. For example, in the past the FDA has sent a serious warning letter to L’Oreal/Lancome in the past (here). Such products also can potentially have health risks.

This Stemáge human stem cell-based cream claims to have anti-aging and other medically beneficial properties. It apparently contains human stem cell laboratory byproducts from other people’s stem cells that are to be used on your skin.

The prices range from about $50 up to around $130 per month. That’s a lot of money in today’s economy.

The company selling the product is Stemage Skin Care, LLC in Charlotte, NC.

Based on its description, in my opinion Stemáge might be a drug that should be evaluated by the FDA prior to any human use, but the company says in its FAQ section that no FDA approval is required. It also reports no side effects.

Is Stemáge a drug?

I don’t know, but it is certainly not your average skin cream that you can get at Walmart or order from QVC.

The Stemáge product is not just being pitched in YouTube ads, but also has its own YouTube videos featuring Ireland as well (see below).

One such video includes the following description as text:

The surgeon developed, adult, human stem cell derived full face and body skin rejuvenation system. Stemáge is supported by trusted advisor, user, and ambassador, Kathy Ireland, and featuring the innovation of Doctor David Scharp of Scharp Laboratories and his key active ingredient, MDFc19.

What is MDFc19?

California-based Sharp Technologies (apparently the same as or related to Sharp Laboratories?) describes MDFc-19 here this way :

(MDFc-19) is a new and important skin care component that contains a number of critical factors, which are produced by expanding adult human mesenchymal stem cells (MSCs).

As a formulation of human cellular factors, again I believe that it is at least reasonable to ask if this MDFc-19 product or other products such as Stemáge that include it are drugs.

The website goes on to say this about MDFc-19:

During our own cell culturing process, human adult MSCs readily expand and grow while releasing their growth and signaling factors into our proprietary media solution. When the stem cells are removed, these important factors are left behind, creating a critical new skin care component for skin care products (MDFc19). Clinical studies have shown that products containing MDFc19 can help reduce the effects aging skin.

What exactly are these clinical studies they claim? Hard to say.

On the clinicaltrials.gov website I found zero results for searches related to Stemáge, MDFc19, and David Scharp.

There was an MDFc19 Wikipedia page up until a few days ago, but Wikipedia editors deleted it. However, the cached page is still available here.

Interestingly, the removed Wiki page claims that they are collaborating with the very prestigious Sanford-Burnham Medical Research Institute.

Scharp Labs provides a  page of more info that makes the claims that MDFc19 does the following:

• Induces collagen production to increase skin thickness
• Reduce scarring
• Reduce inflammation and skin irritation
• Improve skin recovery time from laser treatments
• Reduce wrinkles

These are very impressive sounding, medical claims.

They also have a science page that is quite surprising.

For example, they again claim that Sanford-Burnham is a collaborator, providing “the core scientific analysis for Stemáge”

I emailed a few people at Sanford-Burnham inquiring about this.

No answers yet.

In the end there seem to be more questions than answers about Stemáge. I wonder if the FDA is really OK with such a product and its claims?

As a mixture of human growth factors, cytokines, and other elements made from other people’s stem cells, it seems to me to have many characteristics of a drug. Again, it is not my place to say whether it is a drug or not, but in this case there seems to be reason for at least some concern.

For example, there are possible safety issues such as the potential of the product to contain human viruses, prions, or other human molecules or cellular fragments that could be worrisome. If the human stem cells are grown in fetal bovine serum (FBS), there is also the possibility that customers could be adding factors via Stemáge from fetal cow blood to their face.

Not a very attractive idea in my opinion. Hopefully that is not the case.

I will post Part 2 on Stemage in a few days including quotes from my remarkable conversation with a representative of the company regarding where they get the stem cells and more.

You won’t believe it….or maybe these days you will.

“Say it isn’t so!”, is basically the universal reaction I’m getting from people in the stem cell field.

Well, sadly it seems to be so folks.

What’s going on?

Allegations have emerged on a website called PubPeer (a post-publication review kind of website) about the recent Cell paper by the Mitalipov lab on human therapeutic cloning.

A person called “Peer 1″ has pointed out alleged instances of image duplication and cropping in the paper. The story was also picked up by Retraction Watch. Science is on the story too. Just to be clear, I am not “Peer 1″ as some people have suggested.

A quick look at the paper would suggest there are indeed 3 separate instances of image duplication and images are cropped in various ways that make them look kinda different on first glance.

It makes one feel a bit queasy.

A fourth allegation of inaccurate representation of microarray data related to two panels in Figure S6 in the paper remains more difficult to confirm or deny to this scientist.

The other thing I’m hearing from readers of this blog and others is that they are astonished over the microscopic 3-day period (see image above from the paper) between when the journal Cell received the Mitalipov paper and when it was accepted. A leading stem cell scientist said to me, “Are you f’ing kidding me? 3 days for a human cloning paper?”

Given the 2004/2005 cloning papers by Hwang Woo-suk that proved to be bogus and the highly sensitive nature of human therapeutic cloning, an intense review of the paper before publication would indeed seem like it should have been a no-brainer, eh?

Another leader in the stem cell field told me that Cell should have had 5 independent reviewers look the paper over and have a highly detailed, methodical examination of the paper figure-by-figure, line-by-line, by at least two editors.

Now I’m hearing that we’ll see an announcement by OHSU and Cell as early as tomorrow about this, in all likelihood saying it was all a big innocent mistake.

Maybe it was. I’m betting that to some people though, there will always be doubts after this though.

These serious allegations claim that there are quite a number of images within just this one paper that are reused in cropped forms throughout:

“- Fig. 2F is a slightly cropped version of the cell microscopy image in Fig. 6D top left.

- Fig. 6D top right, the cell microscopy image is a slightly cropped version of supplementary Fig. s5, top right. The cells in 6D are labelled as “h-ESO-NT1 Ph” yet in figure s5 they are labelled to be “hESO-7″. We understand the former to inherit caffeine-treated somatic nuclei whereas the latter are original stem cells.

Under pressure to assemble the figures for rapid publication, one can understand making a cut and paste figure assembly mistake. Nevertheless it should be noted that image cropping does take extra work.

- Figure S6 top centre and top right are the same image.

- Figure S6 middle left and lower right are reported to be biological replicates of microarray expression quantitation. In those cases however the narrow spread indicates that the data are extremely similar and are only understandable as technical replicates (where the same RNA sample is hybridised to two different arrays). It is useful to do technical replicates to control experimental reproducibility, but biological replicates are more valuable when reporting results. They are not the same thing and should not be conflated. (For the record, we did check the microarray data deposited at Gene Expression Omnibus (GSE46397)).”

Cell is reportedly looking into the allegations.

Having looked at the paper again carefully myself just now, it does seem there are instances of image re-use.

If indeed accurate, this raises some doubts about the paper more generally.

Ed Yong appears to deserve a major hat tip for picking up on this and Tweeting it first. It was originally spotted by a commenter named “Peer 1″.

I both emailed and talked on the phone with the President of CAMR, Amy Rick (who by the way is also CEO of the Parkinson’s Action Network (PAN)). Below is a concise summary of our interview.

1. Why now? There are still battles to be fought and CAMR has been so important.  For example the human therapeutic cloning paper has already drawn calls for new legislation against SCNT.

The timing of this decision has nothing to do with the recent SCNT announcement but rather with the general direction of the science and the regulatory issues since the NIH Guidelines were finalized three years ago.  The CAMR Board has been analyzing this issue for months and came to the decision to transfer its mission during the course of this spring.  As I said in the email, the relevant policy issues now go well beyond what has traditionally been CAMR’s focus involving the FDA and CMS, and ARM is already doing an outstanding job advocating in those areas. 

We asked ourselves, ‘ is it really smart to keep it going just in case issues related to hESC research funding arise again?’ and decided it was not wise stewardship.

2. Are you confident that ARM will specifically support hESC research in the future as part of its mission?

We have no doubt that ARM will be just as strong an advocate for federal research funding issues and we hope that many of CAMR’s members will be involved with ARM.  We have consulted with many people interested these issues and there is strong support for this transition. ARM has committed to hESC research and basic research funding.

 3. What about the role of patients and patient advocates? Will they have a role in ARM moving forward after CAMR?

Yes, while ARM has historically not had as broad a representation of patient advocates as ARM, I expect a substantial role for patients in ARM. In fact, some organizations such as PAN are already part of ARM.

4. What can we expect moving forward?

One of the most important points is that when it comes to CAMR, the people are not going away. I expect many to be involved in ARM. As we were considering this change, our focus was on what would be the best way moving forward and I believe this change reflects that and the emphasis on translating therapies.

]]> http://www.ipscell.com/2013/05/interview-with-camr-president-pan-ceo-amy-comstock-rick/feed/ 0 http://www.ipscell.com/2013/05/stem-cell-field-shocker-coalition-for-advancement-of-medical-research-camr-to-dissolve/ http://www.ipscell.com/2013/05/stem-cell-field-shocker-coalition-for-advancement-of-medical-research-camr-to-dissolve/#comments Tue, 21 May 2013 17:59:50 +0000 admin http://www.ipscell.com/?p=15879 Continue reading →]]> The Board of Directors of the Coalition for the Advancement of Medical Research (CAMR) announced today that they have voted to dissolve the organization.

CAMR is effectively at an end.

The CAMR Board has decided, as described in an email, to “transfer its mission and its resources to an outstanding colleague organization, the Alliance for Regenerative Medicine (ARM).”

The press release (PR) from CAMR does not clearly articulate a specific reason for dissolving itself.

In the PR, CAMR president Amy Comstock Rick, J.D, is quoted as follows:

“Human embryonic stem cell research has grown and evolved to a point where it’s time for CAMR to hand off its mission to an organization that can advance policy initiatives to support where the science is now, and where it is headed”

I plan to comment on my thoughts on this development in a blog post later in the week.

This is a big shock for the stem cell field that such a wonderful and still highly relevant organization such as CAMR, after more than a decade of extremely important accomplishments for medical research and stem cells, would choose this particular time to put an end to itself. Another important question is how this event will impact ARM and its mission.

Michael Werner, J.D., executive director of ARM, says in the PR:

“In Washington, D.C., and around the world, researchers and policymakers alike have CAMR leadership and its members to thank for the federal funding guidelines that have helped foster an environment for advances in stem cell research in the past 12 years…We are honored to take on CAMR’s mission, meld it with our own, and continue to support the great science that is already contributing to live-giving advances in regenerative medicine.” 

I’d value the reaction of readers to this startling development. Please comment.

We had the big news last week that for the first time ever, human embryo cloning (aka “therapeutic cloning”) worked to produce apparently normal embryonic stem cells.

I posted about it a few times here, here, and here.

I have tried my best to be factual, open minded, and realistic about the issues.

Frankly, the stem cell field as a whole has done mostly a lousy job handling the human cloning dialogue sparked by the publication of the therapeutic cloning paper last week.

It was one of those classic challenges that was also an opportunity. Unfortunately that window of opportunity is closing, while the challenges will remain or intensify even.

Instead of being part of a rational, fact-based discussion of the ethics and policy issues that were raised, there seems to be a lot of wagon circling and group think going on within the stem cell field.

Some have gone so far as to contact me to say, in effect, “Cut it out!” regarding my open discussion of the cloning issues on this blog. They are not happy with me for my bluntness.

I must not have gotten the memo about the memes that good, well-behaved stem cell researchers are supposed to be sticking to, huh?

Openness and transparency on cloning is crucial, but that’s not what the stem cell field has been advocating in the past week.

What went wrong?

First of all, with all due respect I believe the authors of the paper should have included in their discussion section an overview of the ethical and policy implications of their work. Why didn’t this happen? I don’t know. To be clear, I liked the paper and found it fascinating, but it desperately needed more big picture context.

Second, the journal Cell should have included an accompanying preview and editorial also placing this major finding in the appropriate historical context online. Instead, nothing. Maybe something is coming for the print edition?

Third, the stem cell field should as a whole have been open to discussing the very real issues surrounding this complicated topic of therapeutic cloning and by logical extension the issues surrounding reproductive cloning. The two are at least somewhat linked. That’s a fact that we cannot pretend away.

Yes, cloning is a complicated, ethically challenging issue, but the stem cell field needs to be more open and genuine about talking about it or the field will continue to get criticized  by people on the other side. As a field we also do not engender public trust by futzing around the real issues.

Ethics and policy issues related to cloning should be discussed openly by the field and the leaders of the field have a particular responsibility in this area. I hope to see some of them step up to the plate and show true leadership by talking openly about this stuff.

Dr. Gil Van Bokkelen is Chairman and CEO of Athersys, Inc., a company that has focused heavily on stem cells and regenerative medicine for more than a decade. For more on Dr. Van Bokkelen’s background see additional bio section at the end of this post.

1. Why stem cells? Of all the biotech areas you could have worked on, what inspired you to work on stem cells? Was there a defining moment, for example, in school or during your experience in a lab, when you first heard about them that inspired you?

GVB: Actually, we didn’t start out with a focus on stem cells or regenerative medicine.  In fact, in the beginning we were more interested in the concept of non-viral gene therapy as a novel approach to treating disease.  The team of us that started Athersys were all interested in building a company committed to developing innovative products and technologies that could help us address areas of unmet medical need, and to doing great science.  We believed that by focusing on innovative and cost effective solutions to address big challenges, we could make a difference, and also be in the best position to build a great company and create value for our shareholders.  Initially, we were committed to be the first group to create a human artificial chromosome, essentially a synthetic and miniaturized version of a normal chromosome.  We envisioned this platform could be useful as a non-viral vector for gene therapy, and would enable us to address a range of genetic disorders.  When we published  our work, demonstrating we had established the ability to make synthetic microchoromosomes, it got a lot of scientific and media attention internationally.  That work also shaped our thinking several years later when we became aware of an important new discovery in the field of stem cell biology.  The defining moment for me, related to stem cells and the concept of regenerative medicine, really was meeting Catherine and doing a deep dive with our team looking at her work.  It became pretty clear to me that her team’s discovery had potentially enormous ramifications.  Namely, if one could produce a stem cell therapy in a scalable and consistent manner, that could safely be administered like type-O blood, and that could promote healing and tissue repair in multiple ways, it could transform medicine as we know it in a range of areas.

2. How’s Athersys doing?

GVB: Despite the challenging economic environment of the past several years, I think we’re doing great.  We’ve survived a lot of storms, our pipeline continues to grow and mature, and investors are beginning to recognize and appreciate the value creation potential from our portfolio of programs.  Now it’s largely about executing well, and making sure we have the resources to do what we need to do.  If we stay focused and achieve what we are capable of, I’m confident that one day we’ll be widely recognized as a global leader in the industry.

3. I was recently looking at clinicaltrials.gov and saw 5 Athersys trials listed*. Can you briefly fill us in on how these are going?

GVB: Right now we have 5 clinical stage programs – this includes three in the inflammatory and immune disease area (an ongoing Phase 2 trial to treat patients with Ulcerative Colitis, part of our partnership with Pfizer; a proposed Phase 2/3 trial for preventing GVHD in patients with leukemia or related conditions that is currently under review at the FDA, and a third program in the liver transplant support area). We also have an ongoing Phase 2 trial  in the neurological area (to treat patients that have suffered a stroke), and a Phase 2 trial authorized by the FDA for treating patients that have suffered an acute myocardial infarction (heart attack).    We’re very excited about the stroke and IBD trials that are ongoing and actively enrolling patients.  The trial with Pfizer is essentially a step on the way to evaluating MultiStem as a treatment for Crohn’s disease, which is where I expect the longer term focus to be in IBD.  But the stroke trial could be a game changer, in a lot of ways.  Unless you’ve had a family member or loved one that has suffered a serious stroke, it’s difficult to understand just how big an area of need it is. There are roughly 2 million people a year that suffer a stroke in the U.S., Europe and Japan, and very few patients actually get treated with tPA, the clot dissolving agent that has to be administered within 3 – 4 hours after the stroke.  That time frame is just too tight, and most patients don’t get to the doctor in time.  We and our collaborators have published work from preclinical studies that suggests that we can give MultiStem in more practical time frame following a stroke, perhaps several days.   If it helps patients recover, it could change stroke clinical care, and it’s also an enormous commercial opportunity – which is something that gets our shareholders very excited.  In addition to these programs, we have done a lot of exciting work in other disease and injury areas, especially in inflammatory & immune, neurological, and cardiopulmonary indications.  So we’re actually well positioned to advance quite a few other programs into proof of concept clinical trials when we have the resources to support all that activity.  We don’t expect everything to work, but if we are successful in even a few of these areas, it will be a big deal.

4. MultiStem seems like a “Renaissance” product that can do many things. Is there one particular application that it does best? Is there anything it can’t do?

GVB: The interesting thing about stem cells as therapies is that they can do more than just one thing.  Early on, everyone as thinking about cells simply as a replacement therapy.  However, our experience with MultiStem shows that these cells actually home to sites of tissue damage, inflammation and injury, by responding to certain cues in the body.  We also know they dynamically interact with other cell types and organs in the body, and can promote healing and repair in a variety of ways – primarily by producing multiple factors that enhance repair.  That represents a huge potential advantage over traditional therapeutic approaches, such as pharmaceuticals or biologics that typically only do one very specific thing.  We and our international network of collaborators have seen that MultiStem can reduce inflammatory damage, promote healing and repair through immunomodulatory mechanisms, protect “at risk” cells and tissue through cytoprotective, neurotrophic  or other effects, as well as promote formation of new blood vessels in regions of ischemic injury. That is a really powerful combination of effects.  I think it’s too early to say where the best clinical fit or biggest impact might be – clearly something like stroke could be one of them.  Working with a broad international network of collaborators, we’ve seen promising results in quite a few disease areas, but not everything we have tried has worked the way we hoped.  It is fair to say we’re incredibly excited about the potential across a range of areas. Ultimately, however, we have to determine where our best opportunities are by running rigorously designed clinical trials, that are properly controlled and adequately powered.  These types of trials are the best way to determine whether we are seeing a robust therapeutic effect, as well as consistent safety.  We’ve seen very good safety so far, and some promising signs of efficacy, but we can’t take that for granted.

5. I’m very interested in your work with ARM as Chair as well. What has that experience been like?

GVB: Serving as Chairman of the Alliance for Regenerative Medicine for 2 1/2 years was an extremely challenging and rewarding experience.  When the leadership of the Alliance first asked me to consider it, I was of course, honored.  I also had to think about it, because I knew it would be a lot of work, and I probably wouldn’t see much of my family for a couple of years.  I realized, however, that this was a rare opportunity to really help shape an emerging field that has truly transformational potential.  I was very happy to see the kind of growth we experienced, and the progress on multiple fronts, and I’m confident that will continue with the new leadership team.  When you think about the challenges we face as a society, in terms of areas of significant unmet medical need, an aging population that will require much more in terms of health care resources in the years ahead, and the financial pressures created by the growing demands on Medicare and Medicaid, it becomes pretty obvious that we need to do something. Otherwise, we’re left with a world of healthcare rationing, which nobody really wants.  In my view, technological innovation provides the ultimate solutions to the challenges we face, and in the health care area, I think regenerative medicine has more potential than anything else.  That’s why we need a national strategy, and why I think it makes sense to establish a national or even international initiative in regenerative medicine, that is tantamount to the human genome project.   It’s a strategic investment that could pay huge dividends for all of us.

6. I recently did a post arguing that stem cells are not a zero sum game. In other words, what is good for one type of stem cell (iPSC, adult, embryonic, and now we can add SCNT embryonic) is not necessarily bad for others, and vice versa. In fact, I see the knowledge and advances related to the different kinds of stem cells as being in certain cases additive and even synergistic. Do you buy my argument? Why or why not?

GVB: I absolutely agree.  I think this logic applies on multiple levels, including understanding basic biology, as well as development of technology related to cell therapy manufacturing and other areas.  It’s a bit naïve to think that only one approach will work, or adequately address all the areas of unmet need.  I believe that allogeneic, autologous, and a range of other approaches have tremendous potential. I also think that science has proven that it can help us overcome areas where society has concerns, or reservations about important issues.  A good example of this is the development of iPSC and related technologies, and the emergence of new technologies in the tissue engineering space.  All of these things are positive advancements, and can help us get to where we want to be as a society, and do so in a way where people are comfortable.    I see it as a “rising tide” phenomenon.  As we experience more and more success in various areas, it will generate more and more confidence and excitement.

7. Besides Athersys, can you give us one or two other stem cell-related biotechs that get you excited and why?

GVB: Wow.  I could give you a long list of things I’m excited about.  I’m excited by products that are already on the market and helping people, and the many things I see coming.  I think the next 50 years are going to be filled with exciting innovation in the cell therapy and tissue engineering space.  It would be very hard to pick just one or two.  The notion of being able to really help someone with a serious neurological condition like stroke, Alzheimer’s or Parkinson’s, heart disease or critical limb ischemia, traumatic brain injury, spinal cord injury, diabetes, or many other conditions  where traditional medicine doesn’t have an answer is pretty exciting.  It’s a long list of challenges and opportunities – and some will clearly be more difficult than others – but we don’t need to be successful in all of them in order to have a meaningful impact.

8. What is your perspective on the non-compliant operations out there? How seriously (or not) should we be concerned about them?

GVB: This is an area I worry about a lot.  The biggest thing I worry about is when a desperate family or individual buys into hype around an unproven treatment, and they then spend their life savings on a procedure based on the belief that they are going to be “cured” – when in fact there is no legitimate data to support that hope.  We have to be extremely vigilant about these types of activities.

9. What’s your view of compassionate use of stem cell-based therapies?

GVB:I very much believe that therapies that have a demonstrated record of safety can be appropriately advanced into compassionate use programs, provided there is appropriate regulatory oversight, and the patient or the family member or guardian making the decision on behalf of the individual provides informed consent.  Honestly, in many instances, that may the best way, if not the only way to effectively determine whether a therapy that has demonstrated safety can help someone that is desperately in need, and who may have no other option.   This is especially true in indications where running a traditional clinical trial may be very challenging, or even impossible.

10. What potential changes do you envision in the regulatory arena in coming years? Is there reason for hope for streamlining clinical development, particularly for treatment of patients with unmet needs? How do we balance innovation with safety? 

GVB: I think there are several reasons to be very optimistic, and multiple things are already happening.  Last year the Biotechnology Industry Organization (BIO) led the charge to work with the FDA to implement some important legislation, FDASIA (the FDA Safety and Innovation Act), which included a renewal of PDUFA (the Prescription Drug User Fee Act) and some important new regulatory reforms that will soon go into effect.  A lot of groups, like ARM supported this effort.  These reforms include things like a broadening of the Accelerated Approval pathway, the creation of a “Breakthrough Therapies” paradigm, and other initiatives that will meaningfully shorten development times in areas of unmet medical need.  Those are all really positive steps for the field of regenerative medicine.  Ultimately, however, we all have to remember that the FDA is committed to ensuring patient safety, and I believe we have to not only acknowledge and respect that, we should share that commitment.  But it’s also clear that given the magnitude of the need and the challenges we face, the FDA is now willing to think about things a bit more creatively, and we can work together in a collaborative way to make these new technologies a medical reality faster.  That’s a big step in the right direction.

*there are technically 6 trials listed, but one has been withdrawn.

More on Dr. Van Bokkelen. From 2010 through 2102 Dr. Van Bokkelen served as Chairman of the Alliance for Regenerative Medicine (ARM), the leading policy and advocacy voice for the field of stem cells and regenerative medicine. He is also the Chairman of the Board of Governors for the National Center for Regenerative Medicine, and serves on a number of other boards, including the Biotechnology Industry Organization’s ECS board of directors (from 2001 to 2004, and from 2008 to present), the McGowan Institute for Regenerative Medicine and the Regenerative Medicine Foundation. He received his Ph.D. in Genetics from Stanford University School of Medicine, his B.A. in Economics from the University of California at Berkeley, and his B.A. in Molecular Biology from the University of California at Berkeley.