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).

Scientists Urge President-Elect Obama to Restore US Funding of Stem Cell Research

2008 World Stem Cell Summit in Madison, WI, 22-23 September

Advocates of stem cell research are counting the days until the swearing-in of President-elect Barack Obama, reports the Los Angeles Times. Although President George Bush has strictly limited stem cell research from cell lines derived from human embryos, Obama has long favoured such research and is likely to put a quick end to the federal ban that limits funding of research. Obama has pledged full support of stem cell research, stating recently:

I strongly support expanding research on stem cells. I believe the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations.

As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines … and I will ensure that all research on stem cells is conducted ethically and with rigorous oversight.

The Vancouver Sun reported on Thursday that researchers attending a stem cell conference in Canada were elated with Obama’s win. Clayton Smith, an American researcher who moved to British Columbia five years ago to perform stem cell research, and now heads a lab at the BC Cancer Agency’s Terry Fox Laboratory, told the Sun: “Watching the election last night was a singular event, like watching the Berlin Wall fall.” USA Today reported that people attending the annual fundraiser benefiting the Michael J Fox Foundation in New York Wednesday night were giddy over Obama’s win. “In all fairness, Sen McCain has been supportive of our foundation in the past and supportive of research. But I think this administration will really embrace it,” said Fox, who has Parkinson’s disease. Researchers are hopeful that stem cell research could eventually yield a successful treatment for the disease.

In a press release issued on Thursday the International Society for Stem Cell Research (ISSCR), which represents the world’s leading stem cell scientists, has urged Obama to restore federal funding for embryonic stem cell research in the first 100 days of his presidency. “On August 9, 2001, President Bush declared an executive order banning funding for certain kinds of stem cell research on ideological and religious grounds, not on the basis of the promise of such research for advancing medical knowledge and therapies,” ISSCR President-elect Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine (and a signatory of Declan’s petition to the UN on therapeutic cloning), is quoted as saying in the press release. He added: “This was a dangerous precedent of politicisation of biomedical research, perhaps the first ideological ban of a type of research in America. We urge President-Elect Obama to return to the former policy of investigator-initiated research in all areas of stem cell biology and medicine, overseen by the kinds of safeguards we have advocated in the ISSCR’s Guidelines for the Conduct of Human Embryonic Stem Cell Research.”

According to the Wisconsin Technology Network, to reverse the President Bush’s stem cell policy, which he has pledged to do, Obama does not need an act of Congress or to have his aides prepare an executive order for his signature. He only needs to give a simple order to the director of the National Institutes of Health. Alta Charo, a Warren P Knowles Professor of Law and Bioethics at the University of Wisconsin-Madison Law School, indicated to WTN News that it would be very simple for President Obama to make federal funding available to more embryonic stem cell lines. “Bush’s policy was just that, a policy; that is, a direction given to his NIH director,” Charo wrote in an email. “So Obama can simply direct his NIH director to feel free to fund research on newer lines. No executive order or Congressional action needed.” Charo noted that the only time Congressional action would be needed is if the new President wanted to change the legislative prohibition on using federal funds to work directly on embryos (eg to derive new lines). That’s a reference to the so-called Dickey-Wicker Amendment, said WTN.

Reporting on Friday’s annual stem cell conference at the Salk Institute, La Jolla, CA, the North County Times said that stem cell researchers expect a surge of funding, an easing of restrictions and accelerating scientific progress in turning stem cells into disease treatments. The “Stem Cell Meeting on the Mesa” was presented by the Sanford Consortium for Regenerative Medicine, an alliance of four San Diego research powerhouses: UC San Diego, The Burnham Institute, The Salk Institute and The Scripps Research Institute. Philanthropist T Denny Sanford, after whom the consortium is named, was attending the conference. In September, he gave the consortium $30 million to advance stem cell research. Sanford was optimistic about the prospects for stem cell research, which he called “the medicine of the future”, and the incoming Obama administration’s support of it. “Everything that I’ve heard thus far is that Obama certainly is behind stem cell research, he’ll lift the restrictions currently in place [on federal funding of embryonic stem cell research], so it adds that much more excitement to the field,” Sanford said in an interview before the conference began. (Several distinguished scientists from the Sanford Consortium have signed Declan’s petition.)

The Harvard Crimson quotes Brock Reeve, the executive director of The Harvard Stem Cell Institute (and another signatory of Declan’s petition) as saying: “I think it’s a great moment for the country because one of the things that Obama is doing is placing a greater emphasis on science and relying on different experts in different fields. He’s definitely making science and investment in general a much higher priority.”

According to a report by the nonpartisan Citizens Research Council of Michigan, it is regenerative medicine that is driving the life sciences business sector in Michigan, the United States, and the rest of the world. The report says: “Stem cell research, including human embryonic stem cell research, is seen by many as vital to advancing regenerative medicine. According to a 2006 US Department of Health & Human Services report, a conservative estimate of the worldwide market for regenerative medicine by 2010 is $500 billion. The projected US market is $100 billion.”

Our campaign in support of embryonic stem cell research and therapeutic cloning will argue that stem cell research, including human embryonic stem cell research, is not only vital to advancing regenerative medicine, but has the potential to be an economic boon for countries throughout the world and to lower overall domestic health care costs (see blog of 1 November “Can a cell have a soul?”). And we will voice strong support for researchers and research institutes doing breakthrough work - such as, for example, the Japanese scientists from the Riken Center for Developmental Biology who announced on Thursday that they have been successful in creating a cerebral cortex from embryonic stem cells, thus boosting the possibility of future treatment of brain-related diseases; and the Scottish scientists from the MRC Centre for Regenerative Medicine of Edinburgh University who have been turning embryonic stem cells into a cell type lost in Parkinson’s patients. We will also report on joint international efforts on embryonic stem cell research and applications.

Issues Surrounding Leftover Embryos

The vast majority of emails I am sending to scientists and academics inviting them to sign Declan’s petition to the UN on research cloning of embryos and stem cells are still being dumped to spam boxes (or to cyberspace, see blog of 4 September “Obama: Yes to stem cells, funding”). On Tuesday I sent a total of 304 emails but only received ten out-of-office autoreplies. I emailed scientists and academics at Princeton University, University of Wisconsin, Stanford University, University of Washington, Cold Spring Harbor Laboratory, Burnham Institute, Bristol University and University of Manchester (we have signatories from each of these institutions). I think this is pretty much one autoreply per institution. Yesterday I sent 95 emails to US scientists and academics, received zero autoreplies, and no one I emailed signed yesterday or today.

The Big Issue is a magazine sold by homeless people throughout the UK on registered street pitches. As stated in the blog of 7 October “Letter to the Founder and Editor-in-Chief of The Big Issue”, Declan was informed in writing on 6 October that if we haven’t purchased 40 magazines each week this month, from 10 November we will not be able to have a registered pitch. Yet, I have been waiting four days now for a new badge – all vendors have been re-badged until the end of February 2009, including Declan – despite that Declan was told on Monday I wasn’t allowed to purchase or sell the magazine without it (see email presented below).

Infertility patients are in favor of using leftover embryos for hESC research

One of the three sections of our campaign in support of human embryonic stem cell (hESC) research and therapeutic cloning is “Religion in Public Life” (see blog of 5 October “Next President to Reshape US Supreme Court”); for example, we will monitor Roe v Wade in this section (see blog of 9 October “The fate of Roe v Wade”). Following a recent article in the Los Angeles Times, we will also monitor in this section the key issue for hESC research of leftover embryos from in-vitro fertilisation clinics in the United States.

According to the Times, couples with some of the estimated 500,000 frozen embryos in the US leftover from fertility treatments are “finding themselves ensnared in a debate about when life begins”. About half of couples who have in-vitro fertilisation procedures end up with at least one embryo that is frozen and not transferred to the uterus. According to the Times, such couples have three choices: discard them, donate them to research or donate them to another couple for potential pregnancy. However, the Times reports that measures in several states that seek to protect embryos “could ultimately winnow these options” and potentially limit future fertility treatments, according to some physicians and consumer advocates. “This is taking a pretty private decision and placing it squarely in the public’s eye,” says Nanette Elster, director of the Health Law Institute at DePaul University in Chicago.

Such initiatives include a ballot measure in Colorado that would define a fertilised egg as a person in the state constitution and a proposal by Indiana lawmakers that would allow leftover embryos to be adopted for implantation by another couple. New Jersey legislators have proposed allowing unused embryos to become wards of the state, and Georgia and West Virginia are considering legislation that would grant embryos “personhood status”. Most of these proposals are made by abortion rights opponents, according to the Times. Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison, says banning abortion is the motivation for such measures, adding: “If the Supreme Court allows states to declare embryos as personhood, you would be in a position to say immediately that all abortions have to stop.” By assigning rights to the embryo it would probably make both abortion and human embryonic stem cell research illegal (see blog of 28 September “New Scientist: Their Will Be Done”).

The federal government of the United States supports funding only for one option in dealing with leftover embryos – adoption to another couple for pregnancy. However, research by Anne Drapkin Lyerly, an associate professor of obstetrics and gynecology at Duke University, as well as other surveys, have found that most families prefer not to donate embryos for adoption. In a paper published last year, of 1,020 couples with frozen embryos, 22% said they were somewhat or very likely to donate to another couple. Slightly more said they would probably thaw and discard them. Almost half said they would donate them for research - an option that is often complicated by a lack of research programmes or state restrictions on embryos. No federal funding is available for human embryonic stem cell research using new stem cell lines, and only eight states fund the research – New Jersey, California, Connecticut, Illinois, Maryland, Massachusetts, Wisconsin, and New York.

The Times reports that fertility clinics lose contact with about 15% to 25% of families with frozen embryos. According to the American Society for Reproductive Medicine guidelines, a clinic can consider embryos abandoned and dispose of them if five years have passed without contact with the couple and if significant efforts have been made to reach the couple. Richard Paulson, chief of reproductive endocrinology and infertility at University of Southern California's Keck School of Medicine, said few physicians dispose of leftover embryos. “To my knowledge, no one in the United States has ever done that,” Paulson said, adding: “We’re all paranoid that a couple will show up the next day and say they want their embryos” (Roan, Los Angeles Times, 10/6).

For more information on proposed bills that would change the legal status of frozen embryos, see The Seattle Times under the heading “Embryo legislation”.

This is the email Declan sent this afternoon to the Big Issue outreach manager for London:

Subject: The Big Issue

Dear Mr Paul Joseph

I refer further to your email of 6 October confirming that if my wife and I do not purchase a minimum of 40 magazines each week this month, from 10 November we will no longer be able to have a registered pitch (we "will be allowed to carry on selling but not have priority on any pitch").

On 13, 14 and 15 October I emailed you in respect of my wife's new badge (no. 1170), which, being unavailable for collection at head office on Monday, was due for collection by her at your distribution point at Liverpool Street on Tuesday, then Wednesday, and then today. I can confirm that at 12.15pm today your co-ordinator Renato (1273) reconfirmed that this badge should be available for her to pick up from 1.00pm this afternoon.

I reconfirm that on Monday at head office - following my own re-badging to end of February 2009 and the validation of our pitch authorisation slips until end of Tuesday next week - I was told by your outreach worker Martyn Kalnins that my wife could not purchase or sell The Big Issue without her new (blue) badge.

As I have explained in my previous emails to you, as well as to Martyn on Monday, we cannot afford a second trip to the Big Issue head office this week. Indeed, I can still barely afford to buy two Big Issues. (As you are aware, last week culminated in the so-called "Black Friday" crash; this week shares around the world have continued to tumble, particularly in London; and our pitches are located in the heart of London's financial district.)

Yours sincerely
Declan Heavey
Badge no. 1163

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).