ISSCR Draft Guidelines for Stem Cell Science and Clinical Translation

As a community body the International Society for Stem Cell Research provides leadership and guidance on all matters related to the research and development of safe and effective stem cell science. It's mandate speaks to not only supporting discovery but also to the sound translation of ethical research into potential treatments for those in need.

The below draft on new guidelines was presented last June and has since received comments and has been edited into a final format which was recently published

To prep the release of the new guidelines a Nature Comment article co-authored by an ISSCR guideline task force scientist Insoo Hyun on embryo research  was released entitled "Embryology policy: Revisit the 14-day rule" and referred to the then pending final guideline document.

In addition to the above editorial piece a number of related article were published to support the release of the guidelines, as referred to by the ISSCR.

- "Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines" Stem Cell Reports

- "Policy: Global standards for stem-cell research" Nature Comment

- "New ISSCR guidelines: clinical translation of stem cell research" The Lancet

- "Confronting stem cell hype" Science

An additional overview piece in Nature News captures the essence of the sector's intent on self-regulation with regard to gene-editing, entitled:
"Human-embryo editing now covered by stem-cell guidelines"

Please see below the ISSCR final version, the draft document and my submitted comments as an advocate.



Note: to read the full text boxes in certain sections of the above "Comments" please download the document directly from "In" SlideShare


Crowdfunding > Is it the LSD Science Needs to Engage?

Coming up with a way to sustain science innovation in an ever increasing competitive funding environment is one of the keys to unlocking the potential for next generation treatments and increasing the number of active research projects in-play.

One such method is crowdfunding science projects. A topic that has been in the news on and off for a couple of years but which is now gaining deserved traction.

WALACEA crowdfunding video for Worlds first LSD Brain Imaging Study

To further illustrate, ran a successful fund raising campaign recently for Batten Disease and more than doubled the target sum of $1m with donations of $2.6m. Other recent examples in the 6 to 7 figure tier can be found via the Cambridge, UK based campaign platform, notable for their range of cell based offerings. These types of early development stage sums, if indicative of the trend moving forward, bodes well for participatory science and can have a meaningful impact on progress in the field. 

Some new entries have appeared in the space lately which are geared mostly to smaller scale investigative projects which often go unfunded but which nonetheless have merit and may further the knowledge pool or even bring new treatments that much closer to patients in need.

One stat which was associated with a recent crowd funding start-up from Australia called Researchable noted that 86% of all government applications for funding in Australia are left without resources to proceed. This sounds similar to other stats I've seen elsewhere with regard to funding ratios. 

To be able to tap the public directly for specific projects that interest them is a novel and socially dynamic method of outreach and engagement at the most fundamental level. Tying in a support network of individuals can propel science forward in breath and scope. 

Crowdfunding generally reflects on the successful and privileged world of "angel investing," which looks to individual investors for capital in entry level rounds for new companies. However, in contrast to the selective world of angel investing the advent of online media platforms, with reach to the general public, leverages an ever increasing stream of interest in scientific engagement and furthers the development of potentially impactful progress for the benefit of all. 

This development can work in a non-profit or for-profit manner and therefore can be geared towards independent, institutional and commercial projects, while the data generated can serve as a model for open access feedback.

Scientists that have been unable to fund promising lines of investigation can now look to a new window of opportunity with a view to driving outreach and public benefit education.

This shift is being supported by new laws that allow for more individual participation in the support/investment arena and as a result the potential for successful direct marketing of project funding through the internet is becoming real, albeit on a relatively modest yet growing scale.  

Some of the current names in the crowd funding biotech scene are:

Funds4Research :
Creo en tu proyecto :
Wellfundr :
Aescuvest :
As with all sectors the impact of the how-to evolution via plural open market dynamics associated with technology adoption opens up new doors to move ahead. 



The Blastomere Foundation - A Strategic Approach

Much has been written about the moral dilemma we face as a human race as we rush forward seeking answers and developing in the name of progress. One such debate has been about science and the role of human biology as a means to empower the medical community to treat and cure those that suffer and are in need.

How far do we go in search of such a noble pursuit?

Clearly the world in it's current state have mixed feelings about cloning and embryonics as it touches at the very essence of beginnings of life. Where does life begin and end is a natural question and one we unfortunately can't answer at present - perhaps some day we'll all be illuminated. Until then we must show a degree of respect for the subject IMO - hence Dr. Lanza's work to create Blastomere technology...
The Blastomere Foundation concept is simple.
Create a non-profit foundation to hold and license a number of healthy cell lines derived using this non-destructive embryonic process. All scientific researchers would be welcome to apply for access to this  HESC Stem Cell Bank for FREE without restriction FOR RESEARCH purposes.
IF these researchers and/or their partners wish to commercialize their innovations and products using cells derived from these hesc lines then a standard cell line type FOR CHARITY License fee and royalty structure  would be applicable.
ALL PROCEEDS would be used to help funds treatment for under-privileged children and adults in need through registered non-profit programs at international hospitals and clinics.
This would be run by as a professional non-profit and in it's Charter would be stipulated that no expenses beyond the bare minimum would be allowable to maintain the service.
The Blastomere Foundation is about helping and serving the community for which the technology to treat and cure originates. A few cell lines and the world would open up to the possibilities - especially in Europe and the US where the moral debate has created an unnecessary impediment to progress using our most precious and powerful or natures gifts - our mother cell - without harming it's origin.
Why do this?
HESC needs to break free and assert it's role in a positive way - by empowering science through the adoption of non-destructive Blastomere technology FREE to the community rather than controlled it allows the science foundations to expand faster than it has been able to and as a result ALL will benefit.
ACTC's programs and the other hESC treatment pioneers will be regarded in a new light if we empower others to adopt a Non-Destructive base technology...
Controlling the use of a Middle-Way Non-Destructive Blastomere Technology may produce results down the road but ACTC will be able to do that anyway with a FDA approved NED lines and advanced therapies using those cells... what I'm talking about is clearly a Leadership move to open up the field and empower the adoption of the technology... sort of like allowing the motherboard to be used and duplicated that will enable the software folks to test, treat and cure with intelligent cell systems... 
The more cell system solutions that emerge the more they will be required and the whole infrastructure to support them in the community will be adapted to accommodate....    
I see no reason to not do this and many more reasons to do it... 


(I first Published this in Nov 2012 on iCell)

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