Doctors transplant windpipe with stem cells

The Big Issue is a magazine sold by homeless people throughout the UK on registered street pitches. Given the termination of our Big Issue pitches (see blog of 11 November “Letter of complaint to the chair of The Big Issue Foundation Charity”), we are pretty much unable to keep our account in the local internet café (£3 for seven hours) going and are now restricted to the 3-hour maximum computer use per day at Idea Store Whitechapel library that our local council imposed on each of our membership cards on 1 February. I have had to adapt my blogs accordingly: the emphasis now is on the product of my research into the field of human embryonic stem (hES) cell research and therapeutic cloning, also known as somatic cell nuclear transfer (SCNT) – conferences, news, reports, discoveries and applications, major research institutions throughout world, joint international efforts, bloggers, etc – so that as soon as I have a laptop I am in a position to build within two weeks a website for our campaign in support of hES cell research and SCNT.

Claudia Castillo received trachea grown from her own cells

British newspapers report this morning that surgeons replaced the damaged windpipe of Claudia Castillo, a 30-year-old mother of two, with one created from bone marrow stem cells grown in a laboratory at Bristol University – Declan’s petition to the UN on therapeutic cloning has had 11 signings from Bristol University, and would have a lot more if the vast majority of emails I send to scientists and academics on his behalf were not going to spam boxes, or to cyberspace (see previous blog; on the subject: yesterday, after I posted the blog, I sent 163 emails to the United States, received two out-of office autoreplies, and not unsurprisingly no one signed – to date the petition has been signed by 583 scientists and academics, including 24 Nobel Laureates).

Britain’s top stem cell expert, Professor Stephen Minger of King’s College London (an early signatory of Declan’s petition) told the Evening Standard that the cutting-edge collaboration, involving doctors from Spain, the UK and Italy, was hugely important for future disease treatments. As the first scientist in the UK to grow human embryonic stem cells, he said: “This is a lovely example of how basic stem cell biology continues to yield new, exciting and clinically important treatments. I commend this international research team for such a co-ordinated and successful treatment approach.”

Professor Colin Blakemore of Oxford University, a former chief executive of the UK Medical Research Council (and another signatory of Declan’s petition), has a piece in today’s Times titled “An event that might really deserve to be called a breakthrough”. He writes that advances such as this trachea transplant “are the kind of encouragement that we need to have hope that stem cells and tissue engineering will eventually deliver the promised revolution in medical treatment”. Commenting on hES cell research, he writes: “At the much earliest steps on the ladder to treatment, researchers are now trying to grow entire organs – hearts, kidneys, pancreases – from embryonic stem cells, in test tube conditions. The capacity of embryonic stem cells to turn into virtually any other kind of cell obviously gives them the most potential for organ and tissue replacement. But there is much to learn about how to grow and control them and prevent them being rejected, before they are likely to be widely used.”

In the United States, the Wisconsin State Journal reports today that last week, President-elect Barack Obama’s transition team named a prominent University Wisconsin-Madison researcher - Alta Charo, a bioethicist and law professor who studies issues surrounding embryonic and other stem-cell research – to a panel reviewing federal health policy, including funding hES cell research. Obama has pledged to lift federal restrictions on the research. USA Today comments that Obama “could reignite an emotional national debate over the promise and the perils of medical research using cells taken from human embryos”. It adds: “The United States Conference of Catholic Bishops is warning that Obama will alienate millions, and abortion opponents are bracing for a fight.”

Yesterday I had the time to google the Sanford Consortium for Regenerative Medicine, an alliance of four San Diego research powerhouses: University of California, San Diego, The Burnham Institute, The Salk Institute and The Scripps Research Institute. The consortium renamed itself in September, after announcing a $30 million donation from South Dakota philanthropist T Denny Sanford. Sanford’s funding has been combined with a $43 million grant from the California Institute for Regenerative Medicine to build a four-story facility on North Torrey Pines Mesa for research in regenerative medicine. The new research center is expected to be open by 2010, with groundbreaking set to begin this January. The Consortium coordinated a one-day forum on 7 November at the Salk Institute which attracted several hundred biomedical researchers (Bruce Bigelow reported on the event on Xconomy and Science Network says that videos of the event will be available on its website soon).

Hunting medicine's holy grail

Since Monday I have emailed 402 scientists and academics inviting them to sign Declan's petition to the UN on research cloning of embryos and stem cells (last week it was one signature from 1,072 emails). As usual, the vast majority of the emails were dumped straight to spam boxes or to cyberspace (see blog of 4 September “Obama: Yes to stem cells, funding”) – probably cyberspace because yesterday I included bogus emails (for example, I added an extra “u” to “uk”) and none were returned as undelivered. It may explain why yesterday, out of a total of 173 emails, I only got five out-of-office autoreplies, and just one signatory. Never mind that 59 went to The Wellcome Trust Sanger Institute in Cambridge and 64 to the University College London Medical School – we have several distinguished signatories from each. There is a pattern starting to emerge: signatories come from emails sent either immediately before or after an autoreply – such was the case with two out of the four signatories on Monday.

Spam is not the only difficulty. We also have problems with internet access and computer bookings in our local council’s flagship library, the Idea Store Whitechapel (see blog of 13 October “Letter to the Leader of Tower Hamlets Council”). Only yesterday there was almost no internet access for near on three hours; my booked computer automatically shut down and restarted six times (not even a member of staff could explain why); and in my third and final hour I couldn’t log in for fifteen minutes (this has been happening for some days now) – since 29 January, we have been restricted to a 3-hour maximum computer use per day on each of our membership cards, despite that for several months previous we were given “additional time” subject to computer availability in accordance with the council's then and current “Idea Stores PC Usage Policy”.



World-renowned biologist Alan Trounson, President of the California Institute for Regenerative Medicine (and an honorary associate of NAC), was a guest speaker at AusBiotech 2008, Australia’s biotechnology conference, which took place in Melbourne this week (26-29 October). He discussed worldwide optimism in respect of human embryonic stem cell (hESC) research, pending human clinical trials and the potential of stem cell therapy. In his only interview while in Australia, he told the Sunday Herald Sun: “The world is incredibly optimistic about the use of stem cells, embryonic or other. There will be treatments, there will be cures. We can see the light at the end of the tunnel.” (The CIRM provides the world’s biggest source of funding for hESC research, with a budget of more than $3 billion.)

The stem cell pioneer said that hESC research was ready to prove its potential. “There have been tremendous clinical advances using human embryonic stem cell therapy,” Trounson said. “Things are moving very quickly.” He said scientists working with US biotech company Geron would begin human clinical trials within months following the success of testing the therapy on rats with injured spinal cords. It will be the first time hESC therapy has been tested on patients.

He said more human clinical trials were also imminent. They included testing the ability of hESCs to repair damage to the retina causing blindness (see blog of 26 August “Fighting for the Right to Clone”) and, within two years, overcoming diabetes by using the cells to mature into pancreas cells to produce insulin. “There is a myeloprolific condition that ends up multiplying red blood cells and becoming a preliminary to developing leukemia,” he said. “The scientists were able to block that using a human embryonic stem cell drug and it is now in early trials.”

Stem cell critics are now using the recent advances in adult stem cell research to forward a political agenda, says the International Society for Stem Cell Research (ISSCR). On 22 October, the ISSCR published an open letter in support of all forms of stem cell research, which has been signed by more than 375 of its members. From the introduction to the letter: “As scientists, we are concerned that efforts to favor one arm of stem cell research at the expense of another are based on unsound interpretations of scientific discoveries. Therefore, the ISSCR joined with other leading scientists to issue an open letter to reiterate the urgent need for support for all types of stem cell research, asking members to endorse this open letter.” From the letter (para 2):

Recent exciting advances in the reprogramming of cells in adult human tissues, to convert them into cells that resemble embryonic stem (ES) cells (induced pluripotent stem cells, iPS cells), or to redirect cell fate to enhance tissue repair, have captured the imagination of the scientific community worldwide. Many scientists are very optimistic about the future of this new research. Unfortunately, some in political circles have interpreted this enthusiasm as a verdict that research on human ES cells is no longer necessary. This conclusion is premature and is not scientifically justified.

Meanwhile, the Detroit News reported on Saturday that Michigan voters appear to have growing doubts about Proposal 2, the 4 November ballot proposal that would loosen restrictions on embryonic stem cell research in Michigan (see, for example, blog of 17 October “Stem Cell Research: Five Basic Things To Know”). In an emotional struggle, supporters and opponents have committed $10 million, according to campaign reports filed Friday. A new, Detroit News/WXYZ Action News poll shows the initiative, Proposal 2, leading by 46-43 percent – within the 5-point error margin. A month ago – before a saturation campaign of advertising paid in part by $2.79 million from the Michigan Catholic Conference – it was favoured 50 percent to 32 percent, reports the News. According to one pollster, when a ballot proposal has less than 50 percent support this close to Election Day, it usually is rejected because undecided voters typically vote against ballot proposals. (See here for a series of videos from the University of Michigan in support of hESC research.)

As I wrote in the previous blog, our campaign in support of hESC research and therapeutic cloning, also known as somatic-cell nuclear transfer (SCNT), has been greatly simplified; and that the serious threat to hESC research of the “non-material neuroscience” movement will be dealt with in “Embryonic stem cell research” under “Ethics”. Well, material in an article I have come across in the New York Times by Yale psychologist Paul Bloom (a signatory of Declan’s petition) will likely feature prominently in promulgating the view that the brain is no place to invoke the ‘God of the gaps’ (see blog of 23 October “Creationists declare war over the brain”). Bloom writes: “When people wonder about the moral status of animals or fetuses or stem cells, for instance, they often ask: Does it have a soul? If the answer is yes, then it is a precious individual, deserving of compassion and care.” He concludes by stating: “The great conflict between science and religion in the last century was over evolutionary biology. In this century, it will be over psychology, and the stakes are nothing less than our souls.”

2008 GOP platform calls for total ban on embryonic stem cell research

Although I spend most of my time trying to keep Declan's petition to the UN on research cloning of embryos and stem cells going, the fact is that I believe that most of the emails I am sending to scientists and academics inviting them to sign the petition are still ending up in spam – it would explain the low number of out-of-office autoreplies I continue to receive. (Our local council's Idea Store Whitechapel library has imposed on both our membership cards a maximum of 3 hours of PC access per day since 29 January, despite that for several months previous we were given "additional time" subject to computer availability in accordance with "Idea Stores PC Usage Policy".) On Wednesday I emailed 105 scientists from the Department of Molecular & Cell Biology at the University of California, Berkeley and got six autoreplies (from 2nd, 15th, 22nd, 42nd, 70th and 83rd emails); on Thursday it was 95 emails to the American Association of Anatomists which yielded five autoreplies (from 21st, 22nd, 30th, 47th and 74th emails). On Friday I sent 175 emails for five autoreplies: 14 to the Paterson Institute for Cancer Research in the UK, one autoreply (1st email); and 161 to the Association of Medical School Microbiology and Immunology Chairs, four autoreplies (none before the 78th email). It doesn't surprise me then that on Wednesday night I woke up to a London corporation worker hosing me as well as the pavement (I sleep on the outside; Declan on the inside with our well-tied bags) – a first since we started sleeping in the two-step porch back in November 2006. He looked at me impassively when I sat up – I was quite visible in light which shone through the glass porch door – and continued his hosing. He won't have an excuse next time though: since Friday night, down-light from two overhead bulbs makes the porch feel like an operating theatre – another first.

St Paul, host to the Republican National Convention

The 2008 Republican (GOP) Platform Committee has voted to ban embryonic stem-cell research, including privately funded research using frozen embryos from in-vitro fertilization (IVF) clinics, reports the National Review on Wednesday under the title "Going Out With a Bang". The GOP platform, which states "We call for a ban on human cloning and a ban on the creation of or experimentation on human embryos for research purposes", was passed by state delegates on Wednesday and will be adopted at this week's Republican National Convention in St Paul, Minneapolis.

Ken Blackwell, a former Ohio secretary of state who served as a vice chairman of the committee, said he took particular interest in the subcommittee working on values, which addressed the issue of embryonic stem-cell research. "I think science and history have bridged the different perspectives on that," The Blade reported him as saying. "It's clear to me that breakthroughs in adult stem-cell research make the issue over embryonic stem cells less controversial. This was a discussion driven by the exploration of facts." He said presidential nominee Sen John McCain's advisers and staff were represented throughout the platform-drafting process and that the differences between his beliefs and those of the committee are not indicative of a party divided.

As a senator, McCain has voted in favour of allowing research on human embryos left over from fertility treatments. Nonetheless, advocates of greater federal funding of embryonic stem cell research are worried he will do "an about-face" on the issue if he wins the presidency, says The Hill in an article dated 12 August titled "Stem cell backers doubt McCain's support". McCain's presidential campaign has sought to win over religious conservatives and other factions, including activists who oppose stem cell research. Rep Mike Castle (Del), the chief Republican sponsor of the 2006 and 2007 stem cell bills vetoed by President Bush, told The Hill he wasn't sure whether a President McCain would sign stem cell research legislation. "The question becomes: Will the pro-life movement be able to persuade him otherwise between now and the election?" said Castle.

National Right to Life Committee Executive Director David O’Steen said anti-abortion rights activists think they can turn McCain to their way of thinking on stem cells. "We’d be hopeful that he’d leave [President George W Bush’s] policy in place," O’Steen said. What McCain might actually do, he cautioned, is "an open question". McCain’s campaign did not respond to The Hill’s questions or numerous attempts to obtain a comment for their article. In February, the campaign issued a statement to the Wisconsin State Journal standing behind his record but containing the language O’Steen quoted as evidence of McCain’s flexibility on the issue. "John McCain does support federal funding for embryonic stem cell research," the February statement says in part. "[H]e believes that recent scientific breakthroughs may render this debate academic," according to the statement. "I don’t think he’s ideologically committed to embryonic stem cell research," O’Steen said of McCain. "While Barack Obama is ideologically committed to it, John McCain has indicated that [embryonic] stem cell research is, in his words, 'academic'," he said.

Scientists at Japan’s National Institute of Advanced Industrial Science and Technology, which is funded by the government, announced on 22 August that they had successfully made stem cells from wisdom teeth that had been frozen for three years after being removed from a 10 year old girl. The Baptist Press commented on 26 August: "The developments seem to provide further evidence that advances in such therapies can be accomplished without the unethical step of extracting stem cells from a five- or six-day-old embryo, an action that results in the destruction of the tiny human being." (The BP was formed in 1946 by the Southern Baptist Convention, which is America's largest evangelical denomination with about 16 million members in America, making it the second largest Christian denomination in the United States after the Catholic Church.)

Meanwhile, research published on 27 August in Nature by a team lead by Doug Melton at Harvard Stem Cell Institute that showed it is possible to take a type of adult pancreas cell that doesn't normally produce insulin and reprogram them to produce insulin, prompted Richard Dorflinger, deputy director of the Secretariat of the pro-life activities of the US Conference of Catholic Bishops, to argue that the discovery was the latest evidence that research involving human embryos is no longer necessary. "This adds to the large and growing list of studies helping to make embryonic stem cells irrelevant to medical progress," Doerflinger told the Washington Post. The California Institute for Regenerative Medicine (CIRM), the state stem cell agency, stated the following regarding the research (the full statement, titled "CIRM Applauds the Reprogramming of Pancreas Cells to Produce Insulin Saying It Points to the Value in Pursuing All Research Paths in Regenerative Medicine", can be read here):

CIRM applauds the creativity and value in the research reported and shares the excitement in the promise it might hold. However, it emphatically refutes assertions by opponents of embryonic stem cell research that this new study proves embryonic stem cell research is not necessary. In fact, the Harvard study poignantly points out the value of embryonic stem cell research. Asked if his new findings eliminate the need for work with hESC and iPS cells, the lead Harvard researcher, Doug Melton, said: 'This is a point I want to stress: We are continuing to do research using human embryonic stem cells and iPS cells. We would not be where we are today without having worked with human embryonic stem cells. These unique cells provide a window into human development, and disease development, that is needed if we are to make further progress in understanding and treating chronic diseases. They remain the key to long-term progress in regenerative medicine.' The research reported in Nature is a major advance but it has significant limitations.

Embryonic stem cell research should not be held hostage to politics or religion, argues Nancy Falchuk, the national president of Hadassah, the Women's Zionist Organization of America, in a piece that appeared in The Jewish Daily Forward on Thursday titled "Support Stem-Cell Research". She writes: "Droves of members of both major political parties support the research, evidenced by the congressional passage in 2006 and 2007 of bipartisan bills that, had they not been vetoed by President Bush, would have lifted the federal restrictions. Similarly, support for stem-cell research is not defined by religion. Millions of Americans with strongly held religious beliefs support stem-cell research, a position backed by all major streams of Judaism."

Steven Pinker, world-renowned thinker and Johnstone Family Professor in the Department of Psychology at Harvard University - and an honorary associate of NAC and early signatory of Declan’s petition – wrote in an article for The New Republic, titled "The Stupidity of Dignity", that "the [Catholic] Church's franchise to guide people in the most profound events of their lives - birth, death, and reproduction - is in danger of being undermined when biomedicine scrambles the rules". Well, it’s no wonder that for the Christian right "breakthroughs in adult stem-cell research make the issue over embryonic stem cells less controversial". This is a discussion hardly "driven by the exploration of facts". ("The Stupidity of Dignity" article can be read here; alternatively, see blog of 23 May "The Stupidity of Dignity".)

Therapeutic cloning: Researchers back bid to pay egg donors

The California scientists most likely to receive grants for making new cell lines were those who proposed comparing embryonic stem cell lines and induced pluripotent stem (iPS) cell lines, says Nature Reports Stem Cells in a piece dated 2 July (“What got funded: statistics on California’s new stem cell line grants”).

None of the grant applications submitted to the California Institute for Regenerative Medicine (CIRM) that sought to make lines using human eggs were funded, including three applications that proposed SCNT (somatic cell nuclear transfer), also known as therapeutic cloning. For SCNT applications, reviewers worried that researchers couldn’t get enough human eggs. (SCNT involves transferring the nucleus from an adult human cell into a human egg with the intent of creating stem cells from the resulting embryo. Such cells could potentially serve as a therapy genetically matched to the person who donated the adult cell.)

Somatic Cell Nuclear Transfer illustrated

On 11 June, Nature reported in an article (“Egg shortage hits race to clone human stem cells: Researchers back bid to pay donors”) that US stem cell researchers are calling for changes to state laws that prohibit compensating women who donate eggs for research. It took Kevin Eggan and Douglas Melton, of the Harvard University’s Stem Cell Institute, two years and US$100,000 in local advertising to secure a single egg donor for their attempt to develop embryonic stem cell lines to model diseases such as amyotrophic lateral sclerosis. Eggan says that although Harvard's highly publicised egg-donation programme received plenty of responses, many women decided against donating for research when they were informed that a fertility clinic would compensate them for the same procedure. Currently, laws in California and Massachusetts – two leader states in stem cell research – prohibit compensation for eggs. But with a shortage of available human eggs for research purposes, the issue remains a national sticking point to the progress of stem cell research and cloning science. (Time published an article dated 6 June 2006 titled “Why Harvard is Recruiting Egg Donors for Stem Cell Studies” which can be read here.)

The Scientist also took on this pressing issue when it reported on 27 March that the CIRM may be looking for ways to pay women for their eggs for stem cell research. The article (“CIRM to pay for eggs?”) says one idea that arose at a meeting of CIRM’s Standards Working Group on 28 February was to subsidise the cost of fertility treatment for women donating eggs, as is currently done in the UK. However, Eggan, a member of the CIRM standards group, told The Scientist that he doubts that CIRM can do much in its role as a regulatory agency within the existing legislation. He called on the US National Academy of Sciences (NAS) - which in 2005 recommended in its "Guidelines for Human Embryonic Stem Cell Research" that no payments should be provided for donating eggs, sperm, or blastocysts for research - to revisit the issue, stating that women should be compensated for providing eggs for stem cell research, just as they are for donating eggs to treat infertility and as they were in the early days of IVF research. "Clearly that's the expectation of these women for egg donation," he said. "Human research donors, which is what these women are, should be compensated for their time, their effort, and any duress they incur."

On 26 January 2006, The New England Journal of Medicine reported that Jonathan Moreno, the cochair of the National Academies committee and a professor of biomedical ethics at the University of Virginia, said in an interview that the NAS recommendations were justified by the sensitivity of egg donation for stem cell research and by uncertainties about the actual risk of severe complications in donors; but that John Robertson of the University of Texas School of Law at Austin (and currently chair of the Ethics Committee of the American Society for Reproductive Medicine) said the committee "made a political choice to get the field moving, not an ethical one grounded in sound analysis". Nature points out that Alta Charo, a lawyer and bioethicist at the University of Wisconsin Law School in Madison (and a member of the CIRM standards group), who liaised with the NAS committee that set the donor-compensation guidelines in 2005, says the move “was as much political as ethical”.

A Nature Special Report dated 10 August 2006, titled "Ethicists and biologists ponder the price of eggs", reveals that on 30 June 2006 the International Society for Stem Cell Research (ISSCR) task force released draft guidelines at its annual meeting in Toronto. The guidelines embrace most of the principles proposed by the National Academies in 2005. But differ on the issue of egg donation. The task force leaves the door open for a more liberal policy on compensation by stating simply that stem-cell research projects should be reviewed by a local oversight body, which must ensure "there are no undue inducements or other undue influences for the provision of human materials". What constitutes 'undue' is left to the local oversight bodies. (The ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research can be read here.)

In respect of the UK, in July 2006 the Human Fertilisation and Embryology Authority (HFEA) granted the North-East England Stem Cell Institute (Nesci) - a collaboration between Durham and Newcastle universities - permission to recruit human egg donors; the donated eggs are being used in SCNT experiments to derive embryonic stem cell lines from patients with incurable diseases such as Parkinson's or Alzheimer's. Women donate eggs in return for cut-price in-vitro fertilisation treatment at the Newcastle Fertility Centre. The egg sharing programme has been criticised by opponents of embryonic stem cell research for creating disparity in the quality of care available to people who don’t have the money to undergo fertility treatments; but its supporters say it provides access to such treatments for more people. Alison Murdoch, who is leading the project at Nesci (and is a signatory to Declan’s petition to the UN on therapeutic cloning), said: "Nobody has done nuclear transfer and successfully made stem cell lines yet because of the difficulties of getting hold of human eggs." Nature Reports Stem Cells says Murdoch has so far collected more than 100 eggs.

As Declan and I have been sleeping in the same porch since 3 November 2006, despite that every night now we are under threat of arrest (see blog of 25 June “Police ‘No sleeping’ sign in the porch”), I probably sound too confident but I believe that our international campaign on therapeutic cloning and human embryonic stem cell research is in a unique position to call on the US National Academy of Sciences to revisit the issue of egg donation for research: the justification being that the NAS donor-compensation guidelines have a negative impact at an international level on progress in the field; and can be used by opponents to further restrict and prohibit this life-saving medical research – never mind the Centre for American Progress reporting on 16 July that “80 percent of the public wants medical researchers to have significant influence (39 percent “a great deal”/41 percent “a fair amount”) on stem cell research decisions”. My model for this letter will be a letter to the British Government dated 21 January published in The Times (“Stem cell research is vital and can save lives: The use of lawfully-obtained, anonymised cells must be permitted”), which was signed by almost 60 biomedical researchers and administrators, including four Nobel laureates (many of whom have also signed Declan’s petition).