NIH Releases Draft of Embryonic Stem Cell Guidelines- Overly Restrictive, Overly Permissive, or Just Right?

April 23, 2009 by Ryan Ward

A requirement of President Obama’s Executive Order which removed limitations of NIH funding for human embryonic stem cell research was for the Secretary of Health and Human Services to provide guidelines describing what kinds of human embryonic stem cell research should and shouldn’t be funded. Just recently a draft version of these guidelines was released for public review. Though not yet finalized, this draft provides the framework for the public consultation process (now ongoing) which will ultimately direct the NIH regarding the types of embryonic stem cell research that are within its mandate to support.

Very briefly, the current draft proposes that the NIH only support human embryonic stem cell research if it meets the following criteria:

The embryonic stem cells were derived from human embryos that were created for reproductive purposes, but were no longer needed for this purpose;
The embryonic stem cells were obtained consensually, without coercion or remuneration;
The embryonic stem cells were donated for research purposes, and for which the proper documentation can be assured (further details regarding proper documentation).

Importantly, the current guidelines would prohibit the NIH from funding human embryonic stem cell research if:

The research involves introducing human embryonic stem cells or human induced pluripotent cells into non-human primate blastocysts (the structure that gives rise to the embryo and placenta:);
The research includes the possibility that human embryonic stem cells or human induced pluripotent stem cells may contribute to the germ line (sperm or egg) of a non-human animal;
The embryonic stem cells are derived from other sources, such as somatic cell nuclear transfer, parthenogenesis, and/or in vitro fertilized embryos created for research purposes.

These guidelines try to strike a balance between scientists and the anti-embryonic stem cell position: on one hand allowing research involving cells destined for destruction, on the other limiting funding when it comes to other sources of human embryonic stem cells.

There is no question, however, that these guidelines will allow the NIH to fund human embryonic stem cell research, and not surprisingly there is some objection from the political right. In a press release the President of the Family Research Council stated: "The research that President Obama supports is not sound science and will destroy human life.”

These guidelines would also restrict funding for scientists pursuing research involving embryonic stem cells derived from non-reproductive in vitro fertilization, or somatic cell nuclear transfer (the cloning technology that brought us Dolly the sheep). Again, not surprisingly, these limitations have provoked objections from stem cell biologists who argue that these technologies are important therapeutic avenues for the development of disease-specific human embryonic stem cells.

As mentioned above, these guidelines are now open for public consultation (comments to be mailed in the next 30 days to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997).

To quote the fictitious President Josiah Bartlet of NBC’s The West Wing, “Decisions are made by those who show up”. So, if you feel strongly about human embryonic stem cell research, either pro or con, get out your pen and start writing. It’s time to get involved.

Written by Ryan Ward · Filed Under Home Blog 1, Research

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Rett Syndrome and induced Pluripotent Stem cells goes “Green”

June 17, 2009 by Aaron Cheung

Stem cell researchers at The Hospital for Sick Children have now devised a method, reported in the scientific journal Nature Methods, that will facilitate the generation of induced Pluripotent Stem (iPS) cells. I have previously blogged about the promise of iPS cells (see related articles). iPS cells are cells which have been reprogrammed from a differentiated somatic cell (such as your skin cells) to a pluripotent stem cell (like an embryonic stem cell, only that you don’t need to use embryos!). The generation of iPS cells is inherently very rare which occurs at a frequency of about 0.01% meaning you can generate about one iPS cell line out of hundred thousand cells. Out of which, many lines fail to satisfy the different rigorous tests necessary to be given the prestigious name of “iPS cell”.

A group led by Dr. James Ellis, and lead author Dr. Akitsu Hotta, at The Hospital for Sick Children has generated a reporter, named EOS, that will facilitate the generation of iPS cells for both mouse and human. The reporter has DNA elements (called promoters) that will drive the expression of a fluorescent protein (GFP) and an antibiotic resistance gene (puromycin) that will only turn on in pluripotent stem cells, but remain off in differentiated cells. Therefore, scientists can now generate iPS cells from different sources and the iPS cells will literally “light up with a green colour” once reprogramming has been achieved. Furthermore, by adding puromycin to your culture, it will keep the iPS cells in a pluripotent state as iPS cells will normally spontaneously differentiate.

To demonstrate the applicability of EOS, Ellis also derived iPS cells from patients who have a neurodevelopmental disorder called Rett Syndrome. Rett Syndrome is an Autism Spectrum Disorder which affects almost exclusively females at an incidence of 1 in 10,000 and is one of the leading causes of mental retardation in girls. These Rett Syndrome iPS cells were green when placed under a fluorescent microscope and Ellis demonstrated that neurons can be generated from these Rett Syndrome iPS cells, the cell type affected in Rett Syndrome.

In conclusion, the EOS reporter will facilitate the generation of iPS and will be particularly useful for new labs going into this rapidly developing field. Furthermore, Rett Syndrome iPS cells that were also generated in this study will be invaluable for future drug screens that may be beneficial to those with Rett Syndrome.

Article:
Hotta, A. et al. Isolation of human iPS cells using EOS lentiviral vectors to select for pluripotency. Nature Methods 6, 370–376 (2009).

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