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Researchers have announced the birth of three unusual, though healthy, baby monkeys. They are the first non-mouse chimeras—creatures made up of cells from multiple other parents—to be created by science.

Making chimeric mice is a time-consuming but fairly routine part of biology these days: embryos are injected with modified cultured stem cells containing the traits the researchers desire (like glowing in the dark). Those embryos grow up into mice who have some glow-in-the-dark cells and some normal cells, called chimeras. These chimeras are useful because if any of them have glow-in-the-dark sperm or eggs, they can be bred with each other to produce babies who are 100% glow-in-the-dark.

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Cardiomyocytes damaged by a heart attack

What’s the News: Scientists are devoting countless research hours to treatments based on embryonic stem cells, differentiating these blank-slate cells from embryos into brain cells, light-sensing retinal cells, blood cells, and more to replace damaged or destroyed tissues in the body. Now, a new study in mice shows such that nature has arrived at just such a solution, too: When a pregnant mouse has a heart attack, her fetus donates some of its stem cells to help rebuild the damaged heart tissue.

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Neurons damaged by Parkinson’s disease

What’s the News: Scientists have reversed Parkinson’s disease-like brain damage and motor problems in mice and rats using neurons grown from human embryonic stem cells. The new technique, described online in Nature earlier this week, brings scientists closer to similar treatments for people with Parkinson’s.

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The stem cells formed a sac that then folded in half
a couple days later (see image above, courtesy of Nature),
forming the optic cup.

What’s the News: Give a blob of cells the right environment—lots of nutrients, special chemical signals, and a comfy gel cushion—and they just might grow you a body part. In a feat of bioengineering, scientists at the RIKEN Center for Developmental Biology in Japan have grown a retina from mouse embryonic stem cells. Remarkably, much of the development happened spontaneously, indicating that even undifferentiated cells have a blueprint in mind. Researchers hope the work will someday yield transplantable retinas for people with diseases like retinitis pigmentosa.

“When I received the manuscript, I was stunned, I really was,” commented human molecular geneticist Robin Ali (via Nature News). “I never though I’d see the day where you have recapitulation of development in a dish.”

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Embryonic stem cell treatments are edging closer to mainstream medicine. An experimental treatment just approved for clinical trials may provide hope to the 10 to 15 million elderly patients in the United States who suffer from a common form of macular degeneration, which causes gradual blindness.

The biotech company behind the treatment, Advanced Cell Technology, Inc., previously won FDA approval to try an embryonic stem cell treatment on patients with a rare, juvenile form of macular degeneration. The new FDA-approved trial will use similar techniques, but targets a much broader patient base.

“ACT is now the first company to receive FDA clearance for two hESC (human embryonic stem cell) trials, and is now a true translational leader in the field of regenerative medicine,” said chief executive Gary Rabin. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques.” [AFP]

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Embryonic stem cell treatments are finally breaking out of the lab and arriving in the clinic. In October, the first federally approved trial of a treatment derived from these controversial cells got underway in patients with spinal cord injuries. Now, the FDA has approved a second trial, this one to test a treatment for a rare disease that causes serious vision loss or blindness.

The company behind the trial, Advanced Cell Technology, will test the safety and efficacy of the treatment on 12 patients.

The trial will examine the safety of a therapy for Stargardt’s Macular Degeneration, an inherited juvenile eye disease affecting an estimated 1 in 10,000 young people in the US. As the disease progresses, a layer of the retina called the retinal pigment epithelium (RPE) degenerates, causing vision loss. It’s hoped the new therapy would also work for other types of macular degeneration, a widespread cause of blindness, particularly in the elderly. [Nature blog]

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Yes, it’s a milestone. The first federally approved trial of an embryonic stem cell therapy has begun, and the first patient with a spinal cord injury has been injected with a treatment made from embryonic stem cells. But if all goes well with the trial, conducted by the biotech company Geron, there won’t be any dramatic results–the trial is simply intended to test the treatment’s safety, and patients will receive very low doses of the stem cell concoction.

The patient, whose name was not disclosed, is enrolled at the Shepherd Center, a rehabilitation center in Atlanta; the company has said it plans to enroll 8 to 10 patients in the study at sites around the country. Even if all goes well in the early-stage study, the treatment faces many years of testing for effectiveness before it could be approved as a therapy for spinal injuries. [New York Times]

For the trial, which gained final approval in August, Geron is working with a technique pioneered by the neurobiologist Hans Keirstead, who licensed the technology to Geron.

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UPDATE: In a terse statement (pdf) released today—Thursday, Sept. 9—the U.S. Court of Appeals has issued a stay on the ruling of District Court judge Royce Lamberth against federal funding for embryonic stem cell research. Earlier in the week, Lamberth refused to grant a stay on his own ruling; see below. This doesn’t mean the appeals court is siding with the Justice Department against Lamberth’s ruling; it simply means the three judges want adequate time to consider the ruling and its repercussions. And because the stay lasts until September 20 at least, the National Institutes of Health can re-up the $54 million in projects currently due for annual renewal.

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The ruling stands, for now.

The Obama Administration asked U.S. District Court judge Royce Lamberth to grant a stay of his injunction against federal funding for embryonic stem cell research, insisting that it could trigger job losses and research setbacks. But yesterday the judge issued an order in which he refused to lift the ban, and dismissed the Justice Department’s arguments that the ruling would cause chaos by immediately shutting down all research.

Lamberth indicated that his injunction was less restrictive than had been interpreted by the Obama administration. “Defendants are incorrect about much of their ‘parade of horribles’ that will supposedly result from this Court’s preliminary injunction,” Lamberth wrote. The ruling did not necessarily apply to research that had been funded under guidelines issued during the Bush administration or that had previously been “awarded and funded,” Lamberth wrote. [Washington Post]

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The U.S. Department of Justice has now officially asked Royce Lamberth, the District Court judge who ruled that the Obama administration’s expansion of embryonic stem cell research violated federal law, to suspend the injunction he issued last week that prevents any more funds from going to stem cell projects. The DOJ is also taking the case to the Court of Appeals.

In a 23-page legal filing, Justice Department lawyers said the stay was needed to avoid terminating research projects midstream and negating years of scientific progress toward finding new treatments for devastating illnesses. The department said the ruling would cause irrevocable harm to “millions of extremely sick or injured people” who could benefit from stem-cell research, as well to scientists and taxpayers “who have already spent hundreds of millions of dollars on such research through public funding of projects which will now be forced to shut down and, in many cases, scrapped altogether.” [Wall Street Journal]

Most ongoing projects had been allowed to continue for now, but only if they used National Institutes of Health money to research at their home universities. However, NIH head Francis Collins notes (pdf) the $54 million in projects due for renewal at the end of this month—without a change in the ruling, NIH is forbidden to renew them. Additionally, projects underway on the NIH campus itself have been ordered shut down.

DISCOVER will keep you posted on further updates.

Related Content:
80beats: Stem Cell Decision Fallout: What’s Next, and Who Were the Plaintiffs?
80beats: Judge: Obama’s Expansion of Stem Cell Research Violates Federal Law
80beats: The Trouble With Lab-Created Stem Cells—and Why They Won’t Displace Embryonic Ones
80beats: FDA Green-Lights First Trials Using Embryonic Stem Cells (Again)

Image: iStockphoto

Stem cell work will go on. But the shape of its long-term future is a mystery.

A court ruling yesterday that said the federal government can’t fund embryonic stem cell research even if no money goes to destroying embryos has thrown the field into confusion. Today, though, NIH head Francis Collins says that while the government can’t fund new projects (at least until the legal dispute is resolved), researchers in the middle of federally funded projects can continue.

The legal mess around embryonic stem cell research just got messier. Yesterday a U.S. district judge ruled that President Obama’s expansion of federal financing for the research, enacted last year when he lifted the Bush-era restrictions on creating new stem cell lines, was a violation of federal law.

Judge Lamberth ruled that the administration’s policy violated the clear language of the Dickey-Wicker Amendment, a law passed annually by Congress that bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death” [The New York Times].

Here’s the gist of what happened: The Obama Administration said that its policy fit with Dickey-Wicker because no federal dollars financed the destruction of embryos. Under the new rules the few stem cell lines approved by the Bush administration were OK, and so were new ones from embryos that had already been discarded because they weren’t needed for fertility treatments anymore—if the donors had given their consent to the embryos being used for research purposes. In this compromise position, taxpayer money wouldn’t be used to create new stem cell lines from embryos, but federally funded researchers could work with new stem cell lines created by privately financed scientists.

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Yes, you saw a similar headline in 80beats in January of 2009, but this time we mean it. We think.

Back in 2009 the FDA approved an application from Geron Corporation to begin the first human safety trials of a therapy derived from embryonic stem cells, a move that was heralded as a strong vote of confidence in this controversial but exciting area of medicine. But before the treatment of patients with spinal cord injuries could begin, the FDA reversed course and put a hold on the trial, noting that Geron had discovered cysts in some rats injected with the cells.

Since then, Geron has been scrambling to prove that its treatment is safe via new animal studies, and has agreed to change some procedures to minimize the likelihood of cyst formation. Now that the FDA has signed off, Geron expects to begin the small safety trial (involving only 7 to 10 patients) before the year’s end.

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When scientists first created induced pluripotent stem cells (iPS cells) three years ago, they were hailed as a game-changing advance for medicine: Scientists hoped the engineered cells could duplicate the talents of embryonic stem cells, which can develop into any kind of cell in the body, while avoiding the destruction of embryos. However, a new study by one of the leading U.S. cell labs suggests that iPS cells, at least right now, have serious problems keeping them from reaching their potential.

Advanced Cell Technologies, the Massachusetts lab led by stem cell guru Robert Lanza, released a study of 25 embryonic lines and eight iPS lines in the journal Stem Cells last week. At first they found that human iPS cells could indeed generate blood vessel, blood precursor and retinal cells with characteristics similar to ones derived from embryonic stem cells, albeit with significantly reduced efficiency [Scientific American]. But the blood and retinal cells showed much higher rates of cell death and premature aging. According to Lanza, “there was a 1,000- to 5,000-fold difference” between the iPS cells’ ability to keep growing and dividing and the true embryonic cells’ ability, he says. “In terms of whether you can use the cells therapeutically or to study disease, that’s the difference between getting the study to work and being dead in the water” [Newsweek].

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President Obama followed through yesterday on his plan to ease restrictions on stem cell use in research funded by taxpayer money. National Institutes of Health leader Francis Collins announced that the organization has approved 13 new lines of embryonic stem cells for research, and will consider 96 more lines for approval.

In March, Obama lifted President Bush’s restrictions on federally-funded research on embryonic stem cells, which limited research to a handful of lines created before August 2001. Obama could not on his own reverse the Congressional ruling that forbids scientists from using taxpayer money to create new stem cell lines from embryos, but the ruling allows researchers to use cell lines created by others in an ethical fashion. The NIH set up a panel to decide which stem cell lines met strict ethical restrictions. The cells, for instance, have to have been made using an embryo donated from leftovers at fertility clinics, and parents must have signed detailed consent forms [Reuters].

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The South Korean stem cell scientist who falsified cloning data was convicted today of embezzlement and illegally buying human eggs. The Seoul Central District Court sentenced Hwang Woo-suk to two years in prison for embezzling research funds and illegally buying human eggs. However, it suspended the penalty, allowing him to stay free if he breaks no laws for three years [Washington Post]. The judge stated Hwang has shown remorse and said that despite his fraudulent research the scientist has made other genuine advancements in cloning.

In May 2005, Hwang published a paper in the journal Science, saying his team had extracted material from cloned human embryos that identically matched the DNA of 11 patients. It was claimed such a technique could be the key to providing personalized cures for diseases such as cancer, Alzheimer’s and Parkinson’s [BBC News]. The paper garnered worldwide attention, along with heightened suspicion, because cloning embryonic stem cells was thought to be impossible due to the complexities of human cells. Proving the critics right, an investigation later concluded that the data were intentionally fabricated. Hwang later confessed to obtaining eggs for the research from his female colleagues, a clear violation of research ethics guidelines. However, he maintained that he did not fake his research, and is still working on animal cloning at a local institute.

Related Content:
80beats: Obama’s Guidelines for Stem Cell Research Dodge Controversial Bullets
80beats: Is It Ethical to Pay Women to Donate Eggs for Medical Research?
80beats: Disgraced South Korean Cloning Scientist May Face Jail Time

Image: iStockphoto