"Our experiments did not involve human embryonic stem cells, so we have a lot of stringent work to do to ensure that those types of stem cells can be used safely for human clinical trials," said Bauer. "It certainly is possible, and we are working hard to establish safe and effective human embryonic stem cell-based cures for patients as well."
Nolta and Bauer have worked on eighteen cell and gene therapy clinical therapy trials during their 12 years as colleagues, including stem cell gene therapy trials for adenosine deaminase deficiency, also known as the "Bubble Boy Disease," and stem cell gene therapy for HIV, with colleagues from Children's Hospital Los Angeles, who are also co-authors on the current report.
Bauer is the director of UC Davis' Good Manufacturing Practice (GMP) laboratory in Sacramento. Upon its completion, UC Davis will be one of the few universities with a large GMP facility where scientists will work in an ultra-clean environment to derive cellular products that, after certification and extensive testing, will be used to treat patients. The California Institute for Regenerative Medicine (CIRM) has recommended funding for this new facility to help bring a wide range of stem cell therapy cures to patients throughout California.
According to Nolta, the results of the current study will allow UC Davis to move forward with increased certainty as it prepares for clinical trials.
"We are ready to further develop and test this safe approach to creating effective therapies, and are also using the same model to test the safety of embryonic stem cell-based therapies to fulfill the promise of regenerative medicine." she said.
|Contact: Charles Casey|
University of California - Davis - Health System