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Stemagen steps forward in biotechnology

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Just over two weeks into the New Year, La Jolla-based embryonic stem cell research company Stemagen shocked the world and became the hot topic of conversation among the scientific community worldwide.

On Jan. 17, the company announced it had become the first in the world to create, and meticulously document, a cloned human embryo using somatic cell nuclear transfer (SCNT), or therapeutic cloning.

The achievement is a major step forward in creating person-specific stem cells that could be used for treating ALS, Parkinson's and other degenerative diseases. The company's research is exhaustively detailed in a paper published in a January issue of the peer-reviewed scientific journal Stem Cells.

The company was featured that morning on NBC's "The Today Show" for more than 30 minutes of coverage spread across three separate segments, as well as the lead story on all the evening network news broadcasts.

The following morning, major daily newspaper in several major cities world ran the story as front-page news.

Since the positive coverage, the company has been inundated with inquiries from potential collaborators and investors.

Stemagen's management team has been taking the time to carefully consider each of the several opportunities it has to date been presented with; however, the company does not have any specific or immediate funding needs.

"We are a privately funded company and our needs are being met at this stage," said Dr. Samuel Wood, Stemagen CEO. "This allows us to make sure that if we do decide to collaborate on a project with another company or research institution, it would only be because it's a clear 'win/win' for both parties."

So far, Wood said, all of the invitations for partnering are focused on Stemgen's core mission: creating person-specific embryonic stem cell lines that could be used for therapeutic treatments.

"The achievement we meticulously documented is a major first step toward creating treatments for people who need help right now," he said. "While we can't offer them that, we can offer hope, and we can offer progress."

The company's data is straightforward.

Five blastocysts were developed from 25 donated mature oocytes.

Three were confirmed to be clones based on DNA fingerprinting demonstrating the presence of the skin cell donor DNA in the blastocyst, while one was further confirmed to be a clone by an additional mitochondrial DNA (mtDNA) analysis, which revealed the presence of oocyte donor mtDNA without any oocyte donor nuclear DNA.

For technical reasons, the genetic material in the remaining two blastocysts did not amplify to the extent required for analysis, and so while it is likely they were clones, the evidence required to claim that with certainty was not present. Thus, in this study, cloned blastocysts were successfully created from approximately 10 percent of all mature donated oocytes, an unexpectedly high rate given past research in this field.

The oocytes used in this study were donated, without compensation, by egg donors and intended parents undergoing egg donation cycles for reproductive purposes at the Reproductive Sciences Center (RSC) in La Jolla, a leading fertility center specializing in egg donation and other advanced assisted reproductive technologies.

"As important as stem cell research is, all of us involved in this study realized that our overriding responsibility was to the intended parents who entrusted us with their dream of having a child," said Catharine Adams, a co-author on the paper and RSC laboratory director. "We in the IVF laboratory felt comfortable in this collaboration because we have consistently achieved pregnancy rates of greater than 80 percent from these types of high-quality egg donors. In this study, all the intended parents were successful in achieving a pregnancy."

Stemagen and the RSC worked closely, over an extended period of time, with a leading independent Institutional Review Board to develop procedures ensuring that all parties received comprehensive informed consent and that confidentiality was protected. All research procedures, including the culturing of the skin cells (fibroblasts), were performed under clinical laboratory conditions in close cooperation with the Assisted Reproductive Technologies Laboratory of the RSC, directed by Adams.

Wood, who is also the medical director at RSC, points out that the research was exhaustively scrutinized by some of the world's most respected scientists and underwent an exceptionally rigorous process of verification. "This achievement was so critical to our field, we felt we should spare no effort in the process of establishing the validity of our work," he said.

Jimenez is director of corporate communications for Stemagen.

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