La Jolla, Calif.-based Stemagen, a privately held embryonic stem cell research company, announced today it has become the first in the world to create, and meticulously document, a cloned human embryo using somatic cell nuclear transfer (SCNT).

This is “a critical milestone in the development of patient-specific embryonic stem cells for human therapeutic use, potentially including developing treatments for Parkinson’s, Alzheimer’s and other degenerative diseases,” said CEO Samuel H. Wood, M.D., Ph.D., a co-author of the publication and a donor of the cells from which the embryos were cloned.

The embryos did not yield stem cells, however.

According to an Associated Press report, that fact was the reason some experts “reacted coolly to the research.”

“I found it difficult to determine what was substantially new,” Doug Melton of the Harvard Stem Cell Institute told the AP.

The “next big advance will be to create a human embryonic stem cell line” from cloned embryos, he said. “This has yet to be achieved.”

Dr. George Daley of the Harvard institute and Children’s Hospital Boston told the AP the new report was interesting.

But he agreed that “the real splash” would be when somebody creates stem cell lines from cloned human embryos.

“It’s only a matter of time before some group succeeds,” Daley said.

Stemagen’s research is reported in a paper published in the January 17 issue of the journal Stem Cells.

“This is not merely a technical improvement on previous research in this area,” said chief scientific officer Andrew French, Ph.D., lead author on the paper, “Development of Human Cloned Blastocysts Following Somatic Cell Nuclear Transfer (SCNT) with Adult Fibroblasts.”

“No other scientific group has documented the cloning of an adult human cell, much less been able to grow it to the blastocyst stage, the stage at which it is the adult donor cell that is driving embryonic development, the stage that yields the cells (the inner cell mass) from which embryonic stem cell lines are made.”

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 in La Jolla, a 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, Ph.D., a co-author on the paper and the laboratory director for Reproductive Sciences Center. “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 Reproductive Sciences Center worked closely, over an extended period of time, with a leading independent Institutional Review Board (IRB) to develop procedures ensuring that all parties received comprehensive informed consent and that procedures were in place to protect their confidentiality in the process.

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 (ART) Laboratory of the Reproductive Sciences Center, directed by Catharine Adams, Ph.D.

“An important reason for the success of our SCNT procedures depended on the close coordination between our laboratory personnel and fertility center laboratory staff,” French said. “Timing is a critical element in maximizing the probability of success in this type of procedure.”

Wood said the research was exhaustively scrutinized by scientists and underwent a 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.

DNA fingerprinting is the scientifically accepted method for determining if an embryo is a true clone, the company said.

“All samples were subjected to this type of analysis to determine their true genetic makeup,” French said.

For that, the company turned to Genesis Genetics, a recognized worldwide leader in the field of reproductive embryonic analysis.

Contact: http://www.stemagen.com

Thursday, January 17, 2008 - Stem Cell Business News