San Diego-based Stemagen receives approval for groundbreaking stem cell research.  Privately-funded company receives independent IRB approval for therapeutic cloning.

July 17, 2006

LA JOLLA, CA – Stemagen, a company dedicated to the production of therapeutic stem cells, announced today it has received Institutional Review Board (IRB) approval to develop embryonic stem cells using a comprehensive set of methods, including the process of Somatic Cell Nuclear Transfer (SCNT) for “therapeutic cloning.” Stemagen also received approval to use excess fresh eggs, which have shown in previous research to offer the greatest chance of successfully completing the therapeutic cloning process.

“This landmark IRB approval paves the way for Stemagen to test a new method of producing human stem cells,” said company CEO Samuel Wood, M.D., Ph.D. “We believe this will lead to disease-specific stem cell lines designed to speed the delivery of effective treatments for millions suffering from incurable diseases.”

With this announcement, Stemagen becomes the first in San Diego and one of only a handful of entities in the world to have received independent IRB approval for this promising, but challenging, technology.

“Embryonic stem cells are unique because they are able to self-renew and be directed to become any one of the body’s 220 different cell types,” said Andrew French, Ph.D., Stemagen’s Scientific Director and one of the world’s leading experts on cloning procedures, “We believe they can be a vital component in helping develop treatments for diseases such as Alzheimer’s, Parkinson’s, traumatic spinal cord injury, diabetes, heart disease, rheumatoid arthritis, and hearing and vision loss.”

Stemagen has also received IRB approval to develop human embryonic stem cells from excess embryos donated by couples who would otherwise have chosen to discard them. Wood, who is also one of the country’s leading fertility specialists, said, “After a couple has completed their family using procedures like in vitro fertilization (IVF), it is common to have excess frozen embryos in storage, and unfortunately the vast majority of couples choose to discard them because they are uncomfortable with donating them to other couples for reproductive purposes.  The ability to donate these embryos to an ongoing stem cell research program gives these couples a viable alternative to simply discarding them.”  There are currently an estimated 400,000 frozen embryos in storage at fertility clinics, hospitals and other locations in the United States.

As is required by California law, no egg or embryo donor will be compensated (beyond expenses and lost wages) for donations to stem cell research. “Although finding willing egg donors under these financial constraints is challenging, the response from couples with unneeded embryos has been gratifyingly positive,” says Wood.

Because Proposition 71 funds are still tied up in litigation and because federal funding is not available for this type of research, Stemagen is privately funded. “We realized we could not, in good conscience, wait for Proposition 71 to wind its way through the California legal system, says Wood. “Along with the research being done at UCSF, we believe this is the beginning of the process of fully realizing the promise of Prop 71.”

“Making sure this research is performed in a highly ethical and transparent manner was our highest priority,” says Wood.  To work through the many ethical issues involved in this type of research, Stemagen chose to work with one of the most respected independent human subjects protection programs in the country, Independent Review Consulting, Inc (IRC), headquartered in Northern California. “We are grateful for the several months of effort expended by IRC as we fine-tuned all aspects of our research protocols to ensure that subjects’ rights would be fully protected,” says Wood.

For more information, please contact:

Roman Jimenez

858-435-2305