IVF embryo donation approach gives donors privacy, time

A new paper by CIRM grantees at Stanford University is reporting on an innovative way of ensuring that people considering donating left over in vitro fertilization embryos to research make the best possible decision for themselves. The paper was published on April 8 in Cell Stem Cell.

People who undergo IVF are often left with excess embryos after they complete their families or abandon the process. Storing these embryos in nitrogen comes with a monthly or yearly cost, which is why many people choose to stop storing, which destroys the embryo, donate to another couple or donate to science. In some cases, donating to science includes donating the embryo for stem cell research.

The Stanford group developed a procedure for ensuring that people considering donating to research do so in privacy and aren't influenced by the scientists who could benefit from the research. A Stanford press release describes the procedure quoting senior author Christopher Scott:

In the two-part procedure described in the study, which is now used routinely at Stanford, information about potential donation for research is included in the normal embryo-storage bill from the clinic. “At that point,” Scott said, “the recipients are free to throw the information away or put it on the coffee table to consider and talk about.” Only after the couple has made the initial decision to donate do they interact with Stanford biobank staff members, who use a script to confirm donation choices and answer any questions the potential donors may have.

Specifically, people who indicated that they would like to donate were sent an informed-consent packet outlining the types of research that could be done with the embryos, such as creating embryonic stem cell lines or studying human development. (Research into human development typically occurs during the first 12 days of culture, after which the embryos are no longer grown. Embryonic stem cell research entails creating stem cell lines that can be propagated indefinitely in the laboratory and may be used for both research and therapy.)

Once the potential donors had time to review the material, they then participated in a phone interview with staff members at Stanford’s biobank who were unconnected with either the original in vitro fertilization clinic or the researchers who might use the embryos. Staff members followed a script to confirm the donors’ preferences and make sure they understood their options — including whether they wanted to be notified if the research unearthed any genetic information that might affect their health or the health of their relatives.

People were equally likely to donate to the creation of new stem cell lines or to studying human development. Interestingly, the study found that most donors were primarily concerned that their donated embryo not be used to make a baby for another person.

My colleague Geoff Lomax heads CIRM's Standards Working Group, which sets CIRM regulations for embryo donation for creating embryonic stem cell lines. He told me, "The study results demonstrating differences in research preferences reinforces the need for comprehensive consent for research. I'm glad that development of a safe and supportive stem cell research environment in California can contribute to innovative practice supporting research ethics."

The Stanford press release quotes Stanford biobank research manager and study first author Tasha Kalista:

"Many couples were very relieved to have the option to donate their embryos for research and to participate in the field of stem cell research.”

In some states, people would not have the option of donating embryos and would instead have to destroy the embryo or donate for adoption if they could not or chose not to pay the storage fees.

CIRM Funding: Renee Reijo Pera (CL1-00518-1)
Cell Stem Cell, April 8, 2011

New disease-specific embryonic stem cell lines from Michigan

Stem cell scientists at the University of Michigan and in Detroit have created two embryonic stem cell lines that contain disease-causing mutations: Hemophilia B, a hereditary condition in which the blood does not clot properly and Charcot-Marie-Tooth disease, an inherited disorder leading to degeneration of muscles in the foot, lower leg and hand.

For the first time, scientists will have a way of studying cells that carry the causing mutation and understanding how the disease arises. When the mutation is in embryonic stem cells, it is then carried by any cell type emerging from that line. Maturing the hemophilia line into blood cells, for example, could provide insights into genetic factors associated with disease. These cells also provide a way to test possible therapies in human cells rather than in animals that mimic the disease.

The cells came from embryos created through in vitro fertilization that were determined by preimplantation genetic testing to carry a disease mutation. A few cells from the 3-5 day old IVF embryo are sent to the clinic, and the parents can choose which embryos to implant based on the results. Embryos with possibly lethal disease mutations are generally destroyed as medical waste. Donating t research gives couples an option other than simply destroying the embryos.

The Detroit News wrote about the new lines:

U-M will soon be submitting these disease-specific lines to the National Institutes of Health to be placed on the Human Embryonic Stem Cell Registry. Researchers across the country will be able to use the lines for federally funded research. Of the 91 lines currently on the registry, three are disease-specific stem cell lines submitted by Harvard and Stanford universities.

In the story, Bernard Seigal, executive director of the Florida-based Genetics Policy Institute that hosts the World Stem Cell Summit (to be co-hosted this year by CIRM) said this discovery is a direct result of the passage of Proposal 2, a constitutional amendment that allowed for embryonic stem cell research in Michigan.

The passage of Proposal 2 wasn't just a political statement," Siegel said. "This has been followed up with real, tangible research and real results that have the potential to impact human health. It portends very well for the future of stem cell research in Michigan."

CIRM funds several awards to grantees who are developing embryonic stem cell lines that were found to carry disease-causing mutations through preimplantation genetic testing. These include Julie Baker at Stanford University and Amander Clark at UCL.

- A.A.

New poll finds widespread support for stem cell research

A new Harris Interactive/HealthDay poll came to the not-so-startling conclusion that most Americans support using embryos left over from in vitro fertilization for research purposes, including human embryonic stem cell research.

According to the report, Humphrey Taylor, chairman of the Harris Poll that conducted to online survey said:

"Even among Catholics and born-again Christians, relatively few people believe that stem cell research should be forbidden because it is unethical or immoral."

The process of in vitro fertilization (IVF) can result in ten or more embryos. If a woman gets pregnant quickly, then the remaining embryos stay in a freezer until the couple decides they no longer want to pay for storage. At that time, the couple can either put the embryos up for adoption (an option rarely chosen), discard the embryos — destroying them — or donate them to research. In order to donate those embryos to research rather than discarding them, a couple must give full informed consent that they understand how the resulting stem cells will be used. The NIH will only approve lines for funding that have clear consent and were derived from excess IVF embryos.

One telling finding from the survey was:

Seventy-three percent (versus 72 percent in 2005) believe that stem cell research should be allowed "as long as the parents of the embryo give their permission, and the embryo would otherwise be destroyed."

A recent post on the Baker Institute blog had a nice analysis of the relationship between IVF and stem cell research. In it, the authors write:

With such wide support for IVF, it is remarkable that there is still such a public outcry in the United States over the use of leftover embryos for scientific research. From a moral standpoint, one can argue that in both cases an embryo is destroyed and the destruction of an embryo is always wrong. But isn't it worse to discarding an embryo than to use the embryo for research and development of treatments for currently incurable diseases? Embryonic stem cell research has the potential to bring relief to people suffering from diseases such as Parkinson's disease, muscular dystrophy and diabetes, as well as catastrophic injuries including those to the spinal cord.

Federal agencies such as the NIH can only fund research with already created embryonic stem cell lines. They cannot fund the creation of new lines from discarded IVF embryos. This work is often funded by private agencies or organizations such as CIRM. Here’s a list of all CIRM-funded grants for the creation of new lines.

A.A.

Nobel-winning IVF work laid groundwork for stem cell research

On Monday the Nobel Prize in Physiology or Medicine went to Robert Edwards for his efforts to make in vitro fertilization a reality. The Nobel Prize-winning discovery not only allowed millions of couples to start families, it opened up the field of stem cell research.

According to the Nobel Prize press release:

Approximately four million individuals have so far been born following IVF. Many of them are now adult and some have already become parents. A new field of medicine has emerged, with Robert Edwards leading the process all the way from the fundamental discoveries to the current, successful IVF therapy. His contributions represent a milestone in the development of modern medicine.

Alan Trouson, CIRM president, was in the thick of the early IVF work. He led the team that produced Australia's first IVF baby -- the third in the world. He went on to develop ways of using fertility drugs and freezing embryos to increase the success rate of IVF. He was also among the first to realize the possibilities of taking stem cells from the unused embryos to create cells with the potential to become every cell in the body.

As a sign of how far the IVF field has come, on the same day that Edwards won his Nobel Prize researchers at Stanford University published work showing a technique for selecting which embryos have a 90% chance of resulting in a healthy blastocyst -- a stage of development at about 5 days old, when the embryo is implanted into the mother's womb.

According to a Stanford press release, about 2/3 of embryos created through IVF normally die. Improving those odds could greatly increase the rate of successful IVF pregnancies. The work was led by Renee Reijo Pera, who is also a CIRM grantee (Comprehensive Award and New Cell Lines Award). The release goes on the say:

“It completely surprised me that we could predict embryonic fate so well and so early,” said Reijo Pera. If an embryo’s values fell within certain windows of time for the three predictive parameters, that embryo was more than 90 percent likely to go on to develop successfully into a blastocyst.

Being able to predict which embryos will survive greatly improves a woman's chance of getting pregnant. Riejo Pera is quoted in the release as saying:

"Women, their families and their physicians want to increase the chances of having one healthy baby and avoid high-risk pregnancies, miscarriages or other adverse maternal and fetal outcomes. It’s truly a women’s health issue that affects the broader family.”

Reijo Pera stressed the importance of the work in understanding the earliest stages of human development, where many developmental anomalies are though to originate. It could also be important for the creation of new embryonic stem cell lines, which come from embryos that are discarded from IVF clinics.