Showing posts with label Embryo. Show all posts
Showing posts with label Embryo. Show all posts

First Babies Born Using Genome Editing Technology During IVF


Further to the National Academies report on human genome editing, published in 2017, the self-monitoring governance directive on the sicence to resist human clinical trials for the moment has been challenged by a Chinese scientist who has announced the birth of twins genetically modified to resist HIV infection.

See the following announcements and media coverage on the development:

The National Academies - organizing committee statement
The National Academies - President's & Chinese Academy editorial statement 

The Niche
Science - George Church, geneticist, interview

At the conclusion of the 2nd Human Genome Editing Summit, where the above referred to announcement was debated, a statement by the Organizing Committee was made on the science (here).

Related Blog posts on the developing technology can be found on the Genetics page - specifically Germline Science & Embryo Use and The Rise of Germline Science

Cheers

The Coming of Age of Pluripotent Science & Musings on a Sonogram

usnews
One of the most memorable images I can recall on the effect of catalytic dynamics for me during these years of scientific curiosity was the explosive result of sperm enzyme successfully impacting a human egg - almost Big Bang like in all its microscopic potential.

One can now extend that impact phenomena analogy to the very pertinent research and translational effect Induced Pluripotent Stem Cell (iPSC) technology has had on the field of molecular biology and regenerative medicine.

Nature - Andy Potts
It’s been ten years since Shinya Yamanaka and Kazutoshi Takahashi opened the portal to a whole new way of thinking and practicing the Art of Stem Cell Science by announcing that embryonic like properties could be regained in adult cells through molecular reprogramming.

Royal Society
Much has been written about this apex moment of foundational innovation which ushered in the era of mainstream adoption of reverse engineering techniques on human cells but as we celebrate the ten year anniversary of iPSCs the opportunity presents itself to reflect and celebrate the coming age of Pluripotent science, specifically iPSCs.

Signals of Canada, a leading destination for "insiders’ perspectives on the world of regenerative medicine and stem cell research, written by scientists and professionals in the field" is hosting a "Blog Carnival" of which this article is one of a number being written covering the iPSC anniversary topic. Please click here to read what other bloggers think.

Inherently complex the various Pluripotent states and the multitude of their progressively differentiated descendants, as they relate to human biological microsystems, have only begun to be explored and understood. The inherent processes by which these interconnected derivative cells work and communicate are by and large just now being decoded and mapped. Although it’s been only ten years since the discovery of iPSCs and nearly 20 years since the human embryonic stem cells were first isolated the progress made to-date in translating Pluripotent science into real world clinical programs is very much the focus now of countless labs in the field, thanks in large part to the advent of “open source” iPSC technology. 

Prior to iPSCs the use of hESCs and the technology associated with its clinical translation was largely a specialty area limited in scope by funding, rules, regulations and IP. The advent of iPSCs changed that and with it the stem cell industry added a universal layer of potential. Whether it be using Pluripotent derived cells as tools or more notably to develop therapeutic cell candidates for clinical use those researching and developing applications using these cells are pioneering the way forward for the emerging era of next generation stem cell products.

To put not too fine a point on it, we have only scratched the surface and in the next ten years I expect there will be a number of Pluripotent treatments on the market in various countries and many many more still in the clinic moving towards approval with positive results over standard of care or filling-in where there is currently nothing to offer patients in need.

The topic of what can we expect to see on the frontline of the developing therapeutic market using Pluripotent derived cell products is often highlighted as a discussion point and rightly so given the limited public depth of awareness on the subject and the long standing promise by the sector as a potential basis for effective treatments.

Below are some of the targets and iPSC programs representative of the state of play in the field to look out for:

TARGET - COMPANY/INSTITUTION - LEAD SCIENTIST(S) - CELL - 
DISEASE - AUTO/ALLO*
EYE
Riken/HealiosMasayo TakahashiiRPE++Wet/Dry AMD++Auto>Allo
     Notes: Program will address many disease states of Retina/Eye
Astellas RegMedLanza/MacLareniRNP++Dry AMD/RP++Allo
     Notes: Program will address many disease states of Retina/Eye
UWisconsin WaismanGamm/MeyeriRNP/RPEStargardt+Allo
     Notes: Representative of next gen concept using eye "organoids" 
NEI/CDI-FujiBharti/MilleriRPEDry AMDAuto
     Notes: US Govt backed program 
Cedars Sinai/CIRMShaomei WangiRNPRPAllo
     Notes: Advanced status w/ IND enabling studies 
BRAIN
Kyoto UnivJun TakahashiiNCPakinsonsAllo
     Notes: Leading iPSC Parkinson program due to start in 2017
Sloan KetteringLorenz StudereNC/iNCPakinsonsAllo
     Notes: Top tier US hESC/iPSC lab moving to clinic
Scripps/CIRMJeanne LoringiNCPakinsonsAuto
     Notes: Bringing it home full circle w/ CIRM onboard 
IMMUNE
CynataSlukvin/U WisconsiniMSCGvHD++Allo
     Notes: Entering clinic later in 2016 w/ solid pre-clinical data
Astellas RegMedRobert LanzaiMSCSepsis, Lupus++Allo
     Notes: Multiple targets across board w/ pre-clinical hPSC data
BLOOD
Megakaryon-Kyoto/Tokyo+Eto/Nakauchi/DaleyiPlateletsCancer/Surgery++Allo
     Notes: Leading Japanese program poised to enter clinic in 2017
Novosang-Roslin/SNBTS++Marc TurneriRBCThalassaemia++Allo
     Notes: Leading UK Consortia looking to clinic in 2017
Inserm/PlatODDominique BaruchiPlateletsCancer/Surgery++Allo
     Notes: Leading French program nearing clinic in 2017 
Astellas RegMedRobert LanzaiPlateletsCancer/Surgery++Allo
     Notes: Had a leading program using research grade iPSC line in 2013
Players in CAR/Immuno SpaceiBloodCellsCancer/ImmuneAuto>Allo
     Notes: Auto/Allo B, T, NK, DC+ benefits 4 immuno product requirements


*The above listing is representative of the sector and is not at all comprehensive. Apologies to the many great programs that should be there also.

hiPSC science has industry wide support globally and is a mainstream technology acceptable in jurisdictions in which other ES methods face challenges. Translational hurdles for hiPSC are specific to their reprogramming and to the adult to youthful conversion which forms the basis of the applied technology. This presents an additional safety component to the already strict regulatory oversight applied to the clinical translation of Pluripotent programs now and in the future. 

Will they be highly successful and achieve revolutionary paradigm shifting status and establish new standards of care in their go-to-market quests? 

That is a subjective question for each and every program and one which you could speculate on, yet it would be Hype to suggest definitively without established patient data. However, the indicative MOA and technology basis of those programs on the list point to a sound foundation to work from. 

In my opinion, Pluripotent science, specifically hiPSCs as a universal technology, has the very best chance to score across the board wins for the patient in areas of unmet medical needs. 

Why? 

Some of the reasons I have doggedly believed that lie in the very nature of the plasticity of the sources, youthful phenotypes, cell expression and innate modulatory properties. Other reasons specifically relate to the field’s capacity to precisely derive and modify them in-vitro while perfecting their required derivative purities and expandability to consistently replicate them indefinitely in volume under strict quality control for regulated mass market applications. 

This potential, if successfully delivered together, will usher in a new Pluripotent Era in the Stem Cell Story. 

Commentary

Are we at an inflection point?

pavasoni
Certainly the perceived slow pace of translational activities has been a media drag on the sector, irrespective of the actual comparative timelines to move from bench to bedside. In retrospect there are still only a surprisingly small number of clinical programs in trials worldwide using Pluripotent derived cells, due in large part to stricter preclinical and regulatory standards applied to safety issues associated with these cell sources. So one would say we’re definitely due some momentum building inflection points….  

Human embryonic stem cell trials were initiated in the US some 6 years ago on the basis of only research cell lines after lengthy preclinical research and safety checks. Subsequent small studies in Europe and Korea using hESCs added additional safety data. These trials paved the way for iPSCs yet still today the only enrolled clinical trial for iPSC derived therapeutics is in Japan. This pioneering trial had been on hold for over a year as the cell source analysis flagged possible genetic instability issues and was switched out from an autologous approach to a recently approved allogeneic cell line and is due to resume in 2017. The one patient to-date receiving the iPSC based iRPE cell sheet for Wet AMD has been reported to be in good condition with no apparent safety issues associated with her procedure.

The rigorous standards of the need to use an NIH approved clinical grade cell line in the US has delayed the start of US trials on iPSCs and only just recently has one been announced as available. Pre-clinical lab work one would assume would now need to be done using that line for the clinical trial programs wishing to enter the clinic sometime in the future (yrs) or approval sought and granted for proprietary lines already used for clinical prep on existing developmental programs. This safety issue, albeit necessary and prudent, has forestalled the advancement of Western work and raised the bar from where hESCs entered the clinic.

When discussing timelines and where this segment of the sector is headed it’s important to factor in these types of regulatory hurdles one must overcome on the road to a Pluripotent IND, clinical trial approval and human phased testing. Trial design considerations require stringent oversight monitoring of Pluripotent trials and have and will slow down the translational best efforts of those academic and commercial players entering the space.

Generally if it takes longer that the average drug development process to see stem cell based products enter trials and progress through the Phases and a therapeutic emerge from any stem cell specific regulatory approval pathway people will continue to be disappointed. A scaled approach to the sector’s product entry and exit criteria seems reasonable given the variance of risks associated with different stem cell products under some form of adaptive umbrella.

Safety is of the essence and the nascent SC sector requires everyone err on the side of caution. This is the mantra I hear regularly and I can’t really say it’s not appropriate to a great extent. However, it is this writer’s opinion that the priority should not be overly weighted towards the slowest approach to protect the sector at the expense of patients willing to engage in regulated, open and comprehensive phase development programs designed to enroll and prove the science. Sufficient data can only be generated from a participatory system that is adaptive and accommodating not restrictive and burdensome by design or intent.

A Quad Pregnancy demands care & attention.

lifesitenews
Ashley Gardner Quad IVF Reaction cnn
When I recently scanned the Pluripotent sonogram I saw some Art where 4 heads appeared! Unlike our shock horror double take when 2 appeared in my wife’s scan, I was glad to see the 4 represented there, happily squished together and well. One seems to be growing bigger at the expense of a couple of the others but by and large it’s a Bridge Gang willing and able to take on the challenges when alive and kickin. I personally look forward to seeing them all born healthy and grow, in addition to their Olympic caliber Adult cousins. That would give us semi-oldies the best chance when it´s our turn to ask for help from those wise and experienced in the Jedi ways of healing. This is where Advocacy for Cures comes in. 

buzzfeed
Hope is a powerful force and will always be there for patients in need. Unfortunately the reality is that most next generation Pluripotent cell solutions are still a few steps away, if not more, for those that suffer. High science, low science, no science - too many people continue to be excluded, lack alternatives, suffer & die from disease. Stem Cell Science offers potential solutions and requires stakeholders to rally around programs and data that deliver real world results, even marginal benefits over existing options while awaiting more advanced solutions.

To conclude I have reported on the stem cell industry, specifically the Pluripotent segment for many years, and it has been easily influenced by sentiment and competitive currents rather than sharpening its aim on achieving sector growth. What we all care about most are real solutions for the long list of conditions that continue to ail us and for those that we love. Rather than future technology leading, current programs built on the foundation of pioneering efforts in both the Adult and Pluripotent fields need to be clinically accessible and then successfully delivered widely. Supporting and driving all safe and effective stem cell solutions will propel the entire sector forward.

Safety with pace, open and inclusive. Driving patient centric solutions forward as a community, in a modernized regulatory environment, by design and for the people.

Advocacy for Cures. 

Cheers



Refs:

Cell Press Nucleus - "iPSCs: A Decade of Discovery" (comprehensive review issue)

Cell Stem Cell Editorial: "10 Questions: Clinical Outlook for iPSCs" Cell Stem Cell, Vol 18, Issue 2, 170-173, DOI: 10.1016/j.stem.2016.01.023 (included in review issue ref above)

Ilic, D. and Ogilvie, C. (2016), "Human Embryonic Stem Cells — What Have We Done? What Are We Doing? Where Are We Going?". Stem Cells. doi:10.1002/stem.2450

The Niche, P.Knoepfler: "Yamanaka's baby turns 10 so here's a top 10 list of IPS cell hot button bullet points"  

Progress and the Circle of Scientific Medical Innovation

Designing an adaptable system without the known variables is often an exercise in caution, unless of course you have been down a similar road before and can rely on established templates for creating repurposed guidelines. In some cases however old parameters simply don't fit any longer and the opportunity to engage in the development of more flexible rules with the benefit of hindsight becomes a net positive in the never ending cycle of innovation driven progress.

A series of high profile developments along this path have taken place of late on the topic of genetics and the advent of gene editing technologies that have the potential to alter the fate of human disease and the burden it represents to society. These policy reviews and the resulting position statements have been brought on by concerns that human gene editing presents a challenge to the perceived boundaries by which scientific discovery and possible therapeutic interventions are applied. 

However, as we have seen knowledge trumps and is critical to all human endeavors, given information is paramount to decision making. Accumulating scientific data in the unknown cause and effect realm of biological systems provides the fundamental opportunity to address the task of solving real world problems. This is the tenant by which translational science has always operated and without which we wouldn't have made profound human advances to our condition.     

Existing legislation in Western countries has provided a basis for clarification on the scope of scientific and translational activities, as reviewed here. Europe expressly prohibits at present germ line editing for reproduction. The UK has always had a pro-knowledge framework for discovery using early stage fertilized pre-embryos up to 14 days. The US presently restricts Federal Funding on embryo creation for research and when destructive practices are employed in the lab. 

What is apparent now is the scientific community's consensus on the inherent value of lab study of early embryonic state development using genetic tools to advance knowledge through research while adhering to the principals of caution in progressing any attempts to implement the alteration of the germ line for reproductive purposes. This was the Middle Way path.

The US National Academies summation of their International Summit on Gene Editing affirmed the above in early December last year and called for an ongoing forum to further the dialogue on the topic as the science develops with a view to establishing new recommended guidelines if and when appropriate. The fluid nature of the science requires such and was therefore prudent to set this investigative precedent for all respective regulatory bodies to consider, including the US. 

Previously the UK reaffirmed its position as a leading member of the international scientific community by being the first country to consider Mitochondrial DNA replacement therapy for families with genetic disorders wishing to have a baby free of the diseases associated with such inherited problems. Most recently the UK has agreed to allow genetic research on fertilized pre-embryos for infertility studies without intent to implant for reproductive purposes and always adhering to the prior 14 day limit on embryo development. A modification to the UK law was required for the Mitochondrial DNA therapy to proceed to review stage, while the research on early pre-embryos was already allowable under existing legislative framework which required prior approval and strict oversight.

Following on from the UK's position on Mitochondrial DNA therapy the US National Academies earlier this week announced its recommendation on this genetic intervention procedure for germ-line modification application. The result being an additional affirmation of the scientific potential to alleviate disease through continued research and potential use of the technology in the US. Notable was the necessary recommended investigational support for early pre-embryo studies. Current congressional restrictions inhibit actual Federal support for such studies on viable early stage pre-embryos. This may change in the fiscal year 2017 appropriations Bill as the restriction is not permanent. Support for non-viable pre-embryo research was expressly noted in the US National Academies recommendation paper.           

Both the ISSCR and CIRM have previously stated that they support research on early stage pre-embryos for scientific purposes and have reiterated that position also this week while calling for renewed study of the societal implication of gene therapy and germ line editing.

Commercially the recent change in the position of the European Patent Office on the acceptable use of non-viable pre-embryos methods via germ-line modification brings the alignment closer together and bodes well for the application of various stalled avenues of translational science for the benefit of patients in need. 

Coming around full circle, there would be little progress without the support for all forms of scientific innovation.

Advocacy for Cures.

Cheers

Refs:

1. International Summit on Human Gene Editing Washington DC - "On Human Gene Editing: International Summit Statement" (Dec. 3rd 2016)
2. UK "Scientists get 'gene editing' go-ahead" (BBC Feb. 1st 2016)
3. The National Academies "Clinical Investigations of Mitochondrial Replacement Techniques Are ‘Ethically Permissible’ If Significant Conditions Are Met, Says New Report" (Feb. 3rd 2016)
4. California Stem Cell Report items by David Jensen re: CIRM (1,2) & ISSCR (3) (Feb. 5th 2016)
5. Related blog posts: 1, 2, 3, 4

Naїve Human Pluripotency & The Broad Shoulders of Science

Stevenage, UK BioScience Campus
Scientific debate in the pursuit of knowledge by way of accumulated evidential data is fundamental, just as socio-economic competition is needed to spur innovation, product development & growth in commercial business. Distinct and largely operating on their own, these two worlds have now collided and become integrated in a synthetic process that is driving 21st century evolution.

As a pillar of progress and community success, medical science is a central focus of tomorrow’s design. One in which the health and well-being of society can be calculated and factored into the spreadsheets of sustainability. The footnotes in such macros are bolded as requirements to achieve, yet are a challenge to deliver.  

Salk iPS_Ruiz-StemCell
Given this backdrop the nature of a pluripotent cell, with its ability to generate all tissue types, has been a hot topic of debate and investigation for many years. Its potential is often cited but the field remains a few steps away with many questions still to be answered. 

Source, Stability and Scale – the trinity of our destiny caught in a matrix of possibilities where clarity of method is needed. 

Science knows no bounds when it comes to unresolved issues of definition and process, so the discussion continues. However, with advents in genomic analysis the cell systems of our inner being are becoming clearer and these new insights are helping to provide the answers. 

The human "naїve" cell state in the earliest stages of human embryogenesis is one such focus. The identification and establishment of cell lines along the pluripotent continuum has been a foundational endeavor of the community. Ever since the mouse modelling proved the existence of these powerful engines of growth have the leading labs sought to isolate and engineer the human equivalents. This ongoing work has inspired the field to challenge each other to discover and answer the unresolved questions that will unlock the full potential of pluripotency. 


Whitehead Institute MIT
In its so called "naїve" state the pre-programming of the early cell development machinery hasn't kicked off yet and committed to its natural tissue generating pathways, hence the terminology. The use of cells at this early moment in the cycle could alleviate some of the drawbacks of the standard later stage "primed" version, allowing for more efficient homologous recombination in a therapeutic setting using reprogramming technologies. The naїve state also has a greater proliferation capability and can differentiate more effectively into all desired tissue types. In addition, these cells are able to form inter species chimeras for research and tissue engineering, a highly valuable addition to the toolbox.    

Over the years I have looked for data on early stage embryonic states, specifically any variations in the genetic profiles of pre-compaction blastomeres and ICM hESCs. The Galan, Á. et al (2010) Valencia paper was one such document I found. Of note here in the more recent research done on early human development was that the variation in profiling was correlated to naїve at a specific stage of human embryogenesis at around the 8 cell stage (referred to in Q&A). This moment evidently coincides to the withdrawal of maternal influence yet prior to the blastocyst wave of fate expression.  

Benjamin Dodsworth
I touched on the pluripotent topic during my interviews in Sweden during this year’s annual ISSCR 2015 conference and followed up by reading a then just published paper entitled “The Current State of Naїve HumanPluripotency¹.Benjamin Dodsworth of Oxford co-authored the work with his colleagues Rowan Flynn and Sally Cowley (team leader and head of the James Martin Stem Cell Facility, affiliated to the Oxford Stem Cell Institute, at the Sir William Dunn School of Pathology, University of Oxford).

Sally Cowley Ph.D
The passage in the paper's abstract about the naïve state not being an “artifact” caught my attention and intrigued me given the differing opinions on the subject, the extent to which mouse modelling is representative of human developmental biology and the evolving genetic data analysis of early stage embryonic cell states.

I connected with Ben in a Twitter exchange and he was open to doing a Q&A on the topic, which we started prior to some subsequent developments in the area (iPS “2C” totipotent reprogramming² and the Karolinska paper³ on early human development). Comments on the 2C paper are included in the interview below in [brackets]. 

Thank you Ben for your feedback & good luck with your research.

Cheers

Q&A:

M - With regard to the human Naive state generally and attempts made to create hNaïve cell lines, are we really mainly discussing iPS reprogramming techniques to revert to an earlier point of embryogenesis or would you envision a new methodology for ICM hESC cell lines with them being converted backwards post extraction also? If so do you envision any technical issues associated with than or in their maintenance?

B - Very good point. There are clear parallels to iPS reprogramming techniques. We are currently looking at a method to convert already established human pluripotent stem cell (hPSC) lines to the naïve state. However, if the naïve state is indeed as useful as we anticipate and becomes our new standard, I would expect the emergence of protocols to generate naïve induced pluripotent stem cells directly from primary cells (such as fibroblasts) which skip the primed state. If this holds true, I do expect technical issues. Many protocols for handling hPSCs have been optimised for cells in the primed state. These will not be ideal for naïve cells. Maintenance of naïve human cells might also be challenging and current standard operating procedures will have to be adapted.

M - You mention hESC differentiation pathways that are unreachable - which are those?

B - Endodermal and germline lineages are difficult to access with our current primed hPSCs. This means that although possible, it is inefficient. The Hanna lab have actually used naïve cells to generate primordial germ cells (PGCs) very efficiently. In comparison, primed cells do not efficiently differentiate into PGCs.

Just as important as accessing these differentiation pathways is the maturity of the cells we then produce. Maturity is the extent to which their functions resemble the in vivo cell type. Naïve hPSCs might increase the level of achievable maturity (for example of hepatocytes).

But what I find a lot more interesting is that we have excellent protocols for the differentiation into cells (for example dopaminergic neurons) which work robustly with some hPSC lines but not with others. This heterogeneity could be removed with a protocol which uses cells that are developmentally at the same starting point and without epigenetic bias. The naïve state could deliver on both of these aspects.

M - Has there been any focus on comparative analysis done using hESCs derived from various cell stages of the early human embryonic Blastomere cell stages 2, 4, 8, 16?

B - To my knowledge this has not been performed using hESCs derived from different developmental time points. However, a very useful direct comparison of current naïve and primed hES lines to early human embryonic blastomere cell stages has been performed using single cell transcriptomics by Huang, Maruyama, and Fan (go directly to Figure 2B). They used datasets from Vassena et al., 2011, Xie et al., 2010 and Yan et al., 2013 and compared gene expression to various naïve cells.

M - Why is the Naive state also referred to as Ground State? Is there any technical reason? 

B - Ground state and naïve state both describe the earliest accessible and unbiased cellular state. These terms are interchangeable.

M - Do you believe the reprogramming concept being studied will ultimately be pursued to the point where reversion produces a Totipotent state in order to fully map the process?

B - Possibly, but there are many technical hurdles to overcome and ethical issues to consider.

[M - Do you have a as follow-up comment on this point with regard to the recent Inserm Totipotent development?

B - The 2C paper is indeed a very interesting piece of work which I have been following closely. However, I would like to see more evidence for totipotency, in particular higher efficiency differentiation down difficult lineages such as PGCs. There is not enough evidence to show that these cells are indeed totipotent. For our lab, totipotent cells are unnecessary and we won’t be using these.]

M - Do existing techniques adequately result in Pluripotent cells able to be scaled and applied effectively to therapeutic programs?

B - Current techniques allow the production of induced pluripotent cells to be scaled up. However, before iPS cells can be used therapeutically, the field needs to overcome some fundamental issues. Two main challenges revolve around the host eliciting an immune response to hES or iPS cells even when sourced from the same individual and on the other hand, pluripotent cells have been changed to allow proliferation. This raises concern that these cells could be more susceptible to becoming cancerous. There is a lot of preclinical work to be done.

M - In your conclusion you point to the protocols yielding different results which has yet to be interpreted conclusively, as well as the transient nature of the actual biological moment in-vivo which it may occur. In addition you point to the possibility of a scale of different states along the defined continuum. In that respect would you say any in-vitro activity to reproduce these embryo-genesis states are by defacto man made events and the best we can expect ultimately is a "like" status?

B - Absolutely. Any cell grown into the lab is unlikely to be exactly the same as the in vivo counterpart. As long as we keep this in mind and factor it into our data interpretation, this is not a problem.

M - The data you cite regarding the primate transcript HERVH indicates that mouse systems are distinct to that of primates in this specific area (at least that monkey species). This would indicate that aspects of the human embryo-genesis system are biologically different to that of mouse, in certain ways. Does that perhaps also apply to cell prodigy behavior in your opinion?

B - The paper discussing HERVH is an excellent piece of work which shows compellingly that pluripotency networks are indeed different between human and mouse. And you are right, we can also see these differences in the cellular behaviour. Mouse and human ES cells cannot be cultured in vitro in the same way. The networks which allow capture of naive pluripotency in mouse are not identical to the human system.

M - The utility advantages you mention of Naive versus Primed indicate manufacturing bias towards use of Naive in the future. Can you outline the utility issues specifically for naive cell use and do you view this for specific clinical purposes or for certain discovery processes.

B - Although some labs are currently working on clinical applications, we are focusing on using hPSCs for modelling only. The human naive state promises a lot of benefits – if it is indeed similar to the naive state in mouse. Extrapolating from the mouse, homogeneity would be expected to be improved in naive cell populations. This means that cells are held not in a spectrum of states but all at exactly the same developmental time point. Differentiation protocols could be a lot more effective when applied to a uniform starting point. Other benefits include higher cell yields due to faster doubling times and easier handling.

M - The statement that "TGFβ might not be essential in the human system" caught my attention. Can you elaborate on that in light of published data.

B - In the past, TGFβ signalling was required to maintain hPSCs in culture. However, the requirement of TGFβ signalling is a trait associated with the primed state. In addition, the inhibition of TGFβ signalling increases efficiency of mouse iPSC reprogramming. This is why it would be interesting if we can culture hPSCs without TGFβ.
##

[Follow-up Q relating to the Karolinska analysis paper³ on early human development was left unanswered prior to publishing]

Q&A Refs:

1. Dodsworth, B. et al. (2015). The Current State of Naïve Human Pluripotency. Stem Cells. doi: 10.1002/stem.2085

2. Ishiuchi, T. et al (2015). Early embryonic-like cells are induced by downregulating replication-dependent chromatin assembly. Nature Structural & Molecular Biology 22, 662–671 (2015) doi:10.1038/nsmb.3066

3. Töhönen, V. et al. Novel PRD-like homeodomain transcription factors and retrotransposon elements in early human development. Nat. Commun. 6:8207 doi: 10.1038/ncomms9207 (2015).

4. Huang, K. et al. (2014). The Naïve State of Human Pluripotent Stem Cells: A Synthesis of Stem Cell and Preimplantation Embryo Transcriptome Analyses. Cell Stem Cell 15(4): 410-415.

5. Vassena, R. et al. (2011). Waves of early transcriptional activation and pluripotency program initiation during human preimplantation development Development 138, 3699–3709

6. Xie, D. et al. (2010). Rewirable gene regulatory networks in the preimplantation embryonic development of three mammalian species" Genome Res. 20, 804–815.

7. Yan, L. et al. (2013). Single-cell RNA-Seq profiling of human pre-implantation embryos and embryonic stem cells. Nat. Struct. Mol. Biol. 20, 1131–1139.

Selected Other Refs (in no particular order):

Takahashi/Yamanaka review of the iPS reprogramming pluripotency

Takahashi,K., et al. A developmental framework for induced pluripotency. Development 2015 142: 3274-3285; doi: 10.1242/dev.114249 
______
Salk paper on region specific PSCs (2015):

Wu, J. et al. An alternative pluripotent state confers interspecies chimaeric competency. Nature 521, 316–321 (21 May 2015) doi:10.1038/nature14413
_______
Genomic analysis using single cell RNA (2013)

Xue, Z. et al. Genetic programs in human and mouse early embryos revealed by single-cell RNA sequencing. Nature 500, 593–597 (29 August 2013) doi:10.1038/nature12364
_______
Naive cells in hESC culture using a HERVH promoter & gene analysis of ICM & early embryo cells

Wang, J. et al. (2014). Primate-specific endogenous retrovirus-driven transcription defines naive-like stem cells. Nature 516, 405–409, doi:10.1038/nature13804
_______
1st Naive Paper MIT (w/ Hanna now in Israel, Weizmann)

Hanna, J. et al. (2010). Human embryonic stem cells with biological and epigenetic characteristics similar to those of mouse ESCs. Proc Natl Acad Sci U S A. 2010 May 18; 107(20): 9222–9227.
_______
A.Smith Cambridge downstream transcription factor Tfcp2l1 in Naive conversion

Martello, G. et al (2013). Identification of the missing pluripotency mediator downstream of leukaemia inhibitory factor. EMBO J. 2013 Oct 2; 32(19): 2561–2574. doi: 10.1038/emboj.2013.177
______
Singapore use of 3iL creates a closer native epiblast state of pluripotency "Naive" (rewiring of regulatory circuitry)

Chan, Y-S. et al. (2013). Induction of a Human Pluripotent State with Distinct Regulatory Circuitry that Resembles Preimplantation Epiblast. Cell Stem Cell. 2013 Dec 5; Vol 13, Issue 6. doi:10.1016/j.stem.2013.11.015
______
Hanna Weizmann Institute use of 2iL & in-vitro derivation of mouse like naive cells capable of forming inter-species mouse–human chimeric embryos

Gafni, O. et al (2013). Derivation of novel human ground state naive pluripotent stem cells. Nature. 2013 Dec 12;504(7479):282-6. doi: 10.1038/nature12745.
______
Seattle Washington alternative derivation method to Naive state

Ware, C. et al. (2014). Derivation of naïve human embryonic stem cells. Proc Natl Acad Sci U S A. 2014 Mar 25; 111(12): 4484–4489. doi:10.1073/pnas.1319738111
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Whitehead MIT Talen mediated reporter system for naive derivation medium 5iL (R. Jaenisch)

Theunissen, T. et al. (2014). Systematic Identification of Culture Conditions for Induction and Maintenance of Naive Human Pluripotency. Cell Stem Cell doi: 10.1016/j.stem.2014.07.002
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A. Smith Cambridge team uses simple transient expression of two transcription factors to rewire back to Naive

Takashima, Y. et al (2014). Resetting Transcription Factor Control Circuitry toward Ground-State Pluripotency in Human. Cell, Vol.158, Issue 6, 2014 Sept 11. DOI: 10.1016/j.cell.2014.08.029
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Valencia early embryo gene analysis

Galan, Á. et al (2010). Functional Genomics of 5- to 8-Cell Stage Human Embryos by Blastomere Single-Cell cDNA Analysis. PLOS | One 2010, Oct 26. DOI: 10.1371/journal.pone.0013615
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Developmental biology focus on human tissue

Gerrelli, D. et al. (2015). Enabling research with human embryonic and fetal tissue resources. Development 2015, Sept 15. doi: 10.1242/dev.122820
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Harvard led w/ Daley/Jaenisch/Rossant - Comments by Hanna

De Los Angeles, A. et al (2015). Hallmarks of pluripotency. Nature 525, 469–478 (24 September 2015) doi:10.1038/nature15515