When newcomer Stemagen Inc. burst onto the scene in January with the news that it had successfully cloned an adult human cell and nurtured the resulting embryo to the blastocyst stage, it was one in a string of papers that brought the field back to more general attention.
Faith in embryonic stem cell research had been badly shaken by fraudulent claims about the generation of embryonic stem cell lines in 2005. (See BioWorld Today, Dec. 19, 2005.)
Stemagen scientists reported their success together with the Genesis Genetics Institute and The Reproductive Sciences Center, a fertility clinic, in an early online publication in the peer-reviewed journal Stem Cells. Though the paper did break new scientific ground, it did not, in fact, report the generation of any stem cell lines, which is the point of trying to reach the blastocyst stage.
"The next stage is obviously to generate the embryonic stem cell lines," Stemagen Chief Scientific Officer Andrew French told BioWorld Today, adding that he and his team were keen to do so.
But, he added, the company did not have optimized conditions to generate the stem cells and did not want to risk destroying the blastocyst.
Such destruction would have made it impossible to verify that the blastocyst was indeed a true clone. Because of the scandal surrounding the last claim of human cloning, as well as the possibility of an honest scientific mistake in the form of so-called parthenogenetic activation, senior author Wood and his team decided to concentrate on making sure they had a true clone and save the generation of embryonic stem cell lines for another day.
The publication of the Stem Cells paper marked the first time most people heard of La Jolla, Calif.-based Stemagen Inc. Founded in 2005, the company is more or less at the blastocyst stage itself; it has eight employees and is living exclusively off of private funding. French said that "it's a bit too early" to consider financings.
Stemagen CEO Samuel Wood is medical director at The Reproductive Sciences Center, and French said that Stemagen "relies very heavily on an exclusive collaboration" with the fertility clinic.
Procuring high-quality eggs has been one bottleneck for stem cell researchers, because under ethics rules, paying egg donors is not permitted. In fact, the first problems to come to light with the 2005 claims of embryonic stem cells lines was that the scientists had violated ethics rules by using eggs donated by employees as well as paying for eggs. Collaborating with a fertility clinic translates into a supply of high-quality eggs, though French took care to stress that "we chose a model for egg donation that still had the primary goal of getting the intended parents a pregnancy."
If and when Stemagen researchers do manage to extract embryonic stem cells from blastocysts, the company's plans for them are twofold. Stemagen does hope to harness such cells therapeutically, though French said that the company envisions its role as being "really at the front end, supplying the cell."
"We would be involved in clinical trials," he added, "but that's not our area of expertise."
The company's information materials said that it plans to target ALS, muscular dystrophy, Parkinson's disease and Alzheimer's disease. Not all of those diseases are typical candidates for stem cell therapy; Alzheimer's in particular is a complex disorder. In fact, it would be hard to say which cell would be a candidate for replacement to make a meaningful dent in the clinical symptoms of Alzheimer's disease.
That's where Stemagen's other plans for the stem cells come in - research. "We're looking to produce specific types of cells that would be of interest to some of the largest research groups in San Diego," French said.
It is perhaps a sign of how very early stage Stemagen is that French, when asked about major competitors, lists academic labs as well as companies - Advanced Cell Technology, but also George Daley and Kevin Eggan, both academic researchers at Harvard University.
Of course, the recent advancements in the generation of induced pluripotent cells and their use to treat disorders in animal models, some of them out of Daley's lab, may be on the verge of rendering the question of whether you can get stem cells out of those embryos moot. (See BioWorld Today, Dec. 7, 2007, and Nov. 21, 2007.)
French, though, is optimistic that there is a future for embryonic stem cells - or at least, that the idea will get its day in court. "You can't really make these calls until you've done an adequate comparison," he said. "And those data are not available at this time."