Guest Post from the Maryland Stem Cell Research Fund

By Amritha Jaishankar

Happy Maryland Day from the Maryland Stem Cell Research Fund (MSCRF) at Maryland Technology Development Corp. (TEDCO)!

This year, here at MSCRF, we are skipping the crabs, old bay and beer and choosing instead to spend the weekend engaged in scientific review! As we commemorate the day the first settlers stepped on to Maryland soil, the MSCRF program steps onto new grounds as well!maryland-day blog FINAL

MSCRF was created to promote state-funded stem cell research through grants to public and private entities in Maryland. For the past nine years, MSCRF has invested in basic and translational human stem cell research spanning multiple tissue systems and a wide range of disease areas. We have brought together scientists in academic and industrial settings to innovate and combine cutting-edge technologies in biomedical research and engineering to push the boundaries of human stem cell-based disease modeling and cellular therapies. The progress made by the scientists we support exemplify our mission to advance human stem cell research and develop therapies.

As a program directed and managed by scientists, the value of basic discovery-based research will never be lost on us. However, the scientific progress we’ve seen in the last 10 years in our field and here in Maryland, have enabled us to launch new initiatives this year. The accelerating cures initiative is designed to help translate discoveries from the bench to the bedside through discovery, validation, commercialization and clinical programs.

Our inaugural cycle has proved to be rewarding- more faculty than ever seem open, ready and interested in moving through the program. We are excited to see the progression of previously funded basic discovery projects into validation and early product development. We look forward to helping more stem cell companies in Maryland thrive and expand. We continue to support high-quality clinical trials and we encourage continued innovation and discovery.

I can only speak for myself when I say I became a scientist to have an impact- to cure a disease and to improve human health and the only way to achieve this is by taking the research and innovation out of the lab and to the people! Be a part of the ongoing evolution- commercializing research does not mean you abandon science or fail as an academic, quite the contrary! There isn’t one model that fits all and no single path to commercialization, but we serve as translators and provide an interface and an ecosystem to translate your ideas into tangible products. The path is not easy, of course, for stem cell-based life science start-ups, which require a significantly higher investment of time and money, but the unparalleled potential these technologies offer to cure diseases and save lives make them worth the investment, at least to us.Amritha Jaishankar

We, at TEDCO, know that these first steps onto new land can be intimidating, but we are here to help. We have the expertise and a track-record of successfully partnering with our universities in Maryland to help spin-offs get off the ground. So embark on this journey with us and let us help you navigate, discover and settle on new territories…..go ahead, take that first step!! It’s a great time to be in Maryland!

About the author: Amritha Jaishankar, PhD, MSCRF/TEDCO. Amritha is the MSCRF Award Manager and prior to joining TEDCO was a scientist at The Johns Hopkins University School of Medicine.

Does stem cell clinic IRB approval mean much? Insights from blinding cases

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)?

More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it not being careful enough or even outright enabling risky behavior by those selling non-FDA-approved, experimental stem cell “treatments”?

It can be hard to really be sure. What makes this area particularly muddled is that most of what IRBs do is confidential. We in the stem cell community are as a result left with a bunch of questions in general and about specific cases such as the blinding of these women.

When things go wrong and patients have bad outcomes how much is the responsibility of an IRB versus the stem cell clinics doing the actual experiments? Stem cell clinics often point to their IRB-approved status as some kind of merit badge, but how much does that approval mean? My goal in today’s post is to tackle that last question.

stem cells eyes

Kuriyan, et al. 2017 NEJM Figure 2A showing patient with severely damaged eyes leading to loss of sight

Over at BuzzFeed reporter Peter Aldhous has been following the story of the three women who were blinded by experimental offerings of US Stem Cell, Inc. In Aldhous’ new article he focuses more on US Stem Cell’s IRB. This IRB was run by an organization called the International Cellular Medicine Society (ICMS), which in theory was responsible for overseeing work of US Stem Cell.

There are a host of questions about what happened leading to the women losing their vision and what if any role the ICMS IRB had in overseeing the experiments on these patients. Did US Stem Cell wander outside the scope of ICMS IRB oversight in this case? Could the ICMS IRB have done a better job? If the ICMS IRB did its job well here, I still wonder how they can help to prevent more bad outcomes like this from happening? Presumably the ICMS IRB is overseeing work by many other stem cell clinics as well. How much risk is there at those places? If a business doesn’t follow its IRB’s rules, what happens then? It’s hard to find answers to questions like these. Continue reading

A tale of two stem cell retractions: stark contrast between Macchiarini & Egli

A paper retraction is a major, painful step in science, but sometimes it is necessary and in the past few weeks we’ve seen news of two high-profile stem cell paper retractions. However, these retractions were handled entirely differently by those involved and were prompted by very distinct situations. Update: for some background on stem cell manuscript retractions more generally see from Retraction Watch here and from this blog here.

In the case of a JCI stem cell manuscript retracted by Dieter Egli’s lab, a central problem was with the cells used in the study. The IPS cells had major genomic abnormalities it turned out, prompting the retraction. Senior author Egli and first author Hailing Hua agreed to the retraction due to this problem and due to the fact that after Hua left Egli’s lab, the lab was unable to reproduce the results reported in the paper. As difficult as any retraction is, it seems like Egli handled it far better than most groups do.

Macchiarini retraction

In the second stem cell paper retraction case, we see quite a contrast to the first. Here we have former “star” surgeon Paolo Macchiarini retracting a paper from Nature Communications entitled “Experimental orthotopic transplantation of a tissue-engineered oesophagus in rats”. Retraction Watch has been on this case for some time and done a lot of other reporting on Macchiarini’s travails that involve investigations of other papers too. The Karolinska Institute (KI) dismissed Macchiarini amid accusations of misconduct. Continue reading

The Real Stem Cells of Beverly Hills?

They say a picture is worth a thousand words and with stem cell clinics and GoogleMaps, maybe it’s true.

When Leigh Turner and I published our stem cell clinic paper in Cell Stem Cell last year, Beverly Hills stood out as a top hot spot for these businesses selling non-FDA approved stem cells.

Beverly Hills Stem Cells

GoogleMaps results from “Stem Cells Beverly Hills” search

See the GoogleMap image from a search today above with the search terms, “Stem cells Beverly Hills”. According to GoogleMaps, just drive down Wilshire Boulevard through Beverly Hills and you could sample many of the stem cell businesses, some of which are just blocks from one another.

It’s like the stem cell direct-to-consumer epicenter of the universe.  

I’m not saying that everything or everyone listed in this map from GoogleMaps is a stem cell clinic, but many are. I recognize almost all of these entities, but I don’t recall Jian N. Ye as a stem cell provider.

There are so many entities on this map that Google couldn’t fit the names of all of them in there. There are also some others off the edge of this particular map but nearby. Continue reading

On St. Patrick’s Day, an update on stem cells in Ireland by Stephen Sullivan

Happy St. Patrick’s Day from the Irish Stem Cell Foundation (www.stemcell.ie)! I’ve included a few picture from the parade here in Ireland.

St. Patrick's Day Parade Ireland MusicianScientifically, Ireland is going through a lean period. The national science funding agency SFI is having its first grant call in 2 years. If recent history is a predictor, they are more likely to fund grants based on geography (which centre or college you are associated with) and how quick the perceived economic benefit will be. This means information technology (particularly areas like Fin Tech) are a lot more likely to get funded than long term pursuits like biomedical research. It is not surprising then that we see the national centre for regenerative medicine research (REMEDI) being subsumed by the centre for medical devices (CURAM) as there has been little evidence of an immediate economic return.

This move may actually might be a good thing for stem cell research in Ireland, as the centre has had a near monopoly of national funding for the last ten years or so, meaning if you were not a researcher at the centre, you weren’t likely to get stem cell work funded. There are researchers with stem cell expertise in other colleges and centres now who might be supported in the future. So we shall wait and see what happens.

St. Patrick's Day Parade Ireland Politically speaking, science is weaker in Ireland now than at any point in the last twenty years, Ireland has lost its national council for bioethics, its independent office of Chief Scientific Advisor (the public servant charged with dispersing Ireland’s investment into science, is now also charged with assessing its impact – an obvious conflict of interest). Worse again, we have no Government minister with Science mentioned explicitly in their brief. So as North American scientists mobilise against denial of Science in public policy or proposed funding cuts, it’s something we have struggled with in Ireland for some time.

Despite the climate, Irish stem cell researchers have to fight against misinformation peddled by scammers and the zealous. A recent discussion I partook in at the BBC shows the particular problems we face in Ireland with regard to stem cell research, often it with get rolled in with a lot of ancillary topics that the Irish Government has also not dealt with. Thus, it is our job to extricate all the different topics and show where the status of each truly lies.

The short discussion included topics as diverse as stem cell tourism, reproductive cloning, artificial embryos, embryonic- and induced pluripotent- stem cells, 3 parent IVF, IVF embryo storage, artificial wombs, and the history of ‘fake news’ in cloning: Dolly the sheep ‘eating shepards’, and stem cell derived-sperm and eggs.

Hard work and slow progress.

You can listen to it by clicking here and scrolling in 34 minutes into the program where our discussion starts. Feel free to tell us what you think at @irishstemcell on Twitter or via email info@stemcell.ie.

Stephen Sullivan PhD, CSO Irish Stem Cell Foundation