Scientist in the garden: How to grow cool tomatoes

I’ve always grown tomatoes in my garden and I like unusual varieties. This year I’ve got a bunch of cool tomatoes growing out back. Some are now starting to ripen so it’s getting more exciting.

Growing tomatoes is not as hard as I thought originally, but there are some tricks. I’m going to do a separate post fully on tomato growing tips. Some key ones are pick the sunniest spot in your yard, work on the soil every year including via green cover crops, don’t over-water or over-fertilize, and mulch.

Below I’ve posted pictures I took just this week of some of my favorite unusual varieties. We just had some Lovers Lunch and Berkeley Pink Tye Die for breakfast today and they were amazing.

Lovers Lunch Tomato

Lovers Lunch Tomato

Berkeley Pink Tye Die Tomato

Berkeley Pink Tye Die Tomato

Lucid Gem tomato

Lucid Gem tomato

Bull’s Heart Tomato

Beauty King Tomato

Beauty King Tomato

FIX IT! SF Chronicle runs striking stem cell clinic ad with coupon

stem cell ad couponI’ve seen stem cell clinic ad after ad pop up in the mainstream media in my own hometown in The Sacramento Bee paper, but others are sprouting as well and a friend sent me a particularly striking stem cell advertisement from a recent copy of the San Francisco Chronicle.

Not only does this stem cell clinic say you can come to a free stem cell seminar, but also you get a free lunch and $1,000 off a stem cell “treatment” of some kind if you go to the seminar.

The clinic in question seems to be called Advanced Health Center. The providers mentioned are Dr. Max Wirjo, M.D. as well as Drs. Brian and Jeff Coyle, D.C., F.A.S.B.E. I’m not familiar with these folks, but looked them up on the web. Wirjo seems to be an anesthesiologist. The Coyles, perhaps brothers, are chiropractors. On a quick search I couldn’t find any other links between these three providers and stem cells on the web at least. What kind of stem cell experience do they have?

The ad makes a number of potential medical claims including that the marketed offerings can “fix” a number of medical problems (see the big “FIX IT!” in the ad). The offering is described as effective, which is a medical claim, and in fact is called “most effective”. There are also claims of “long lasting” results. It is at least indirectly implied that the stem cell therapy being marketed can grow new cartilage, ligaments, and muscle, which is a very big claim. On their website on the stem cell therapy specific page, claims are again made in videos from R3 Stem Cell.

Does this seminar being promoted fit into the category of what I call “stem cell clinic infomercials”, which I wrote about recently in a Stem Cells and Translational Medicine article here?

When I see an ad like this, other questions come to mind. What data if any is behind it? How many patients will be experimented upon? How much patients pay? What are the risks and potential negative outcomes? Have they talked to the FDA?

Have you all seen ads like these? If so please send my way. Thanks.

CRISPR, human genetic modification, & a needed course correction

Are designer babies made using CRISPR or other genetic modification technologies closer to reality today? If so, what exactly should we do about it?

Researchers can use CRISPR to genetically modify just about any organism or its cells, but targeting humans is the subject of the most intense discussion including using CRISPR in the human germline for heritable “editing” or genetic modification of humans. This could in theory be done via human embryos or human germ cells with mostly existing technology.cover GMO Sapiens

CRISPR studies on healthy human embryos are apparently now being conducted in the UK and Sweden by Kathy Niakan and Frederick Lanner and potentially others (see here and here) strictly for research (not reproduction).

I support the use of CRISPR for early human embryo research, but it needs to be done carefully and with proper bioethical oversight as well as transparency. To my knowledge to date, no team working on CRISPR in health human embryos has been willing to even say what genes they are targeting so that’s a problem in my view. I would guess at least one group is aiming to knock out key pluripotency genes such as OCT4 and NANOG in otherwise normal human embryos. Will we learn dramatically more about human early embryo development that is distinct from findings in mouse embryos on the same genes? I hope so, but you never know.

We also need to realize that the moment one of these studies on intentional genetic modification of healthy human embryos is published there is a good chance there will be a political firestorm in response from some quarters. This is in part why seemingly pro-heritable human modification arguments popping up need to be responded to and discussed as even the strictly research-focused CRISPR work in healthy human embryos will lead to invocations of germline human modification. Continue reading

Highlights of ISSCR2017 – A Biomedical Engineer’s Perspective

By Agnes SoosAgnes Soos

Amid the hustle and bustle of downtown Boston, nearly four thousand researchers and exhibitors gathered for the 15th Annual ISSCR Meeting. With presentations from over thirty plenary lectures, and dozens of others featured in concurrent sessions and the daily Innovation Showcases, there definitely was no shortage of exciting research to discover and discuss. There was a record number of exhibitors this year with over 150 companies set up in Exhibit Hall. Added to this, the always-busy Meet-Up Hubs, the job boards peppered with posted offerings, and the popular Meet-the-Experts luncheons and Junior Investigator Career Panel (both with full wait-lists) offered an array of networking opportunities that definitely did not disappoint!ISSCR2017-book&badge,closeup

Though the program broadly covered stem cells in development, disease, and their applications to human health, iPSC-related work featured prominently throughout the Meeting. Central to this focus on iPSC research – and quite popular among the attendees – was the plenary talk by Shinya Yamanaka. His lecture discussed the two major medical applications of iPSCs: cell therapy and disease model/drug development. Under the cell therapy topic, he relayed the high costs associated with autologous treatments and outlined the research that has gone into identifying HLA homozygous “super” donors to overcome the prohibitive nature of allogeneic therapies. Though a first transplant was successfully performed in March of this year, this work still faces some challenges. Namely, facility-dependent handling practices appear to impact the occurrence of mutations within cancer-driving genes of the iPSC clones, necessitating further study and perhaps tighter control of how these cultures are handled. On the topic of disease modeling and drug development, Yamanaka outlined early successes in using iPSCs to gain a better understanding of Fibrodysplasia Ossificans Progressiva and the effective use of patient-derived cultures to conduct in vitro drug screening.

Organoids and organogenesis was a hot topic at this year’s Meeting with dedicated plenary and concurrent sessions offering an array of excellent talks. Juergen Knoblich’s plenary lecture presented the advantages offered by 3D organoid cultures – namely, their ability to recapitulate features of brain development and disease which cannot be easily studied using animal model systems. For example, cerebral organoids have been developed using patient-specific iPSCs to model microcephaly. Knoblich also discussed some of the advantages of introducing bioengineered matrices to manipulate organoids, demonstrating improved organoid generation with specific scaffold materials. Although organoid ‘mini-brains’ to study neural development and disease were the topic of several talks, other areas of organoid research included intestinal epithelium (‘mini guts’), pancreas, kidney, liver, and lung.ISSCR2017-Overlooking (part of) Exhibit Hall

Other highlights included talks from the recipients of the McEwen Award for Innovation, Elaine Fuchs, and the Dr. Susan Lim Award for Outstanding Young Investigator, Jayaraj Rajagopal. Fuchs expertly summarized four decades of research on skin stem cells in a mere 20 minutes, covering the current understanding of stem cell activity and function in normal tissue, with aging, and in cancer, using the skin as a model system, with focus on cells within the hair follicle niche. Rajagopal lectured on the topic of airway epithelium and the interactions of three constituent cell types – a stem cell, progenitor cell, and post-mitotic differentiated cell. He presented the value of this model in studying regeneration and outlined the complexity of cellular interactions in this relatively simple cellular ensemble. Both of these talks were presented as part of the plenary session on Tissue Regeneration and Homeostasis.

Unsurprisingly, lectures in all sessions presented some very exciting science. Topics covered in the other plenary talks included: Chromatin and RNA Biology in Stem Cells, Stem Cells and Cancer, Stem Cells and Stress, Senescence, and Aging, and the Frontiers of Cell Therapy.

In addition to the above, perhaps the most memorable talk of the Meeting was the address by Sanford Greenberg on his quest to end blindness. Greenberg discussed his own experiences, relaying the struggles he faced when he become blind at 19 years of age. He outlined the goals of the Greenberg Prize, a $3 million award (in gold), which has the intent of rallying the international research community to focus efforts towards ending blindness by year 2020.

Developing effective treatments – or perhaps even cures – through clinical applications of some of the research presented at the Meeting does appear promising. This was exemplified by the work presented in the final plenary session by Masayo Takahashi on the successful use of iPSC for retinal cell therapy. However, although the results of this work are cause for excitement, Takahashi emphasized the importance of being cautious in our optimism. Though there may be progress, she is often faced with the challenge of being unable to accommodate all patients seeking treatment. Thus, she emphasized, although we must promote our successes, we should avoid placing too much emphasis on champion cases and avoid hype, so that together we may see healthy progress within the stem cell field.

US Stem Cell bid for FDA RMAT rejected?

Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up.

Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The company’s penny stock $USRM has been gyrating for months and I had earlier wondered if could be some fake news about it. The USRM news now seems real and not good on the RMAT front. Shares plummeted earlier this week (see earlier stock graph above).

US Stem Cell Inc.As to plans, here’s something from an apparent company PR:

“Until then, U.S. Stem Cell will focus on opening new clinics around the country to better serve patients in need. In addition to the original Sunrise clinic (that has successfully treated hundreds of patients and generated over $2m in revenues in the past 12 months alone), recent clinic openings include Miami and Palm Beach, Florida. Upcoming openings include Dallas, Texas (thanks in part to the early adoption of patient rights by the State of Texas), Chicago, Atlanta, and Denver – as well as other clinics in the northeast and the west coast.”

Opening more clinics…selling non-FDA approved offerings?

This may be what the company sees as a good business move, but in my opinion it puts more patients at potential risk and takes their money for “stem cell treatments” that are not conclusively proven to be safe or effective. I have not seen RCT data from USRM to support their commercial stem cell efforts.

What happened with the US Stem Cell, Inc. RMAT application? We may never know for sure, but rejection by the FDA is one possibility. Over at the RAPS site, a new piece on CBER has this to say (“Marks” refers to CBER Director Peter Marks):

“Thanks to the 21st Century Cures Act, FDA now has a new designation for regenerative medicines, known as the regenerative medicine advanced therapy (RMAT) designation. As of last week, Marks said there have been 19 requests for RMAT designations, 18 of which CBER has acted on, and four of which have been granted…’

Unless US Stem Cell, Inc. is the 1 out of the 19 applications on which the FDA has not acted, then it’s not looking promising for their RMAT just based on the odds. Another possibility is the FDA did not reject it, but asked US Stem Cell for a lot more data and that constitutes “acted on”.

It’s worth a reminder that this business was linked to the blinding of three patients in a presentation at a 2016 FDA meeting and in a NEJM publication. The company has had patient lawsuits too, which seem to have been settled out of court.

More broadly in the oversight arena, to my knowledge the FDA and CBER specifically have not issued any warning letters to or taken other actions (at least in the public domain) on stem cell clinics in ages despite hundreds of such businesses marketing unproven stem cell offerings without FDA approval. And whatever happened to those four key FDA draft guidances? Does CBER have enough funding and staff to tackle the burgeoning stem cell business arena? It remains unclear how the FDA and CBER will handle key challenges under the new Trump administration and with new FDA Commissioner Scott Gottlieb.