PUBLIC RELEASE DATE:

23-Oct-2014

Contact: Scott LaFee slafee@ucsd.edu 619-543-6163 University of California - San Diego @UCSanDiego

In a push to further speed clinical development of emerging stem cell therapies, Sanford Stem Cell Clinical Center at UC San Diego Health System was named today one of three new "alpha clinics" by the California Institute for Regenerative Medicine (CIRM), the state's stem cell agency.

The announcement, made at a public meeting in Los Angeles of the CIRM Governing Board, includes an award of $8 million for each of three sites. The other alpha grant recipients are the City of Hope hospital near Los Angeles and University of California, Los Angeles.

"A UC San Diego alpha clinic will provide vital infrastructure for establishing a comprehensive regenerative medicine clinical hub that can support the unusual complexity of first-in-human stem cell-related clinical trials," said Catriona Jamieson, MD, PhD, associate professor of medicine at UC San Diego School of Medicine, deputy director of the Sanford Stem Cell Clinical Center, director of the UC San Diego Moores Cancer Center stem cell program and the alpha clinic grant's principal investigator.

"The designation is essential in much the same manner that comprehensive cancer center status is an assurance of scientific rigor and clinical quality. It will attract patients, funding agencies and study sponsors to participate in, support and accelerate novel stem cell clinical trials and ancillary studies for a range of arduous diseases."

The alpha clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-based drugs and therapies in humans, including some developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.

The clinics will also emphasize public education to raise awareness and understanding of stem cell science in part to combat "stem cell tourism" and the marketing of unproven, unregulated and potentially dangerous therapies and help establish sustainable business models for future, approved stem cell treatments.

"Everything we do has one simple goal, to accelerate the development of successful treatments for people in need," said C. Randal Mills, PhD, CIRM president and CEO. "Stem cell therapies are a new way of treating disease; instead of managing symptoms, cellular medicine has the power to replace or regenerate damaged tissues and organs. And so we need to explore new and innovative ways of accelerating clinical research with stem cells. That is what we hope these alpha stem cell clinics will accomplish."

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UC San Diego named stem cell 'alpha clinic'

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Newswise In a study that will provide the foundation for scientists to better replicate natural stem cell development in an artificial environment, UCLA researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research led by Dr. Guoping Fan, professor of human genetics, have established a benchmarking standard to assess how culture conditions used to procure stem cells in the lab compare to those found in the human embryo.

The study was published online ahead of print in the journal Cell Stem Cell.

Pluripotent stem cells (PSCs) are cells that can transform into almost any cell in the human body. Scientists have long cultured PSCs in the laboratory (in vitro) using many different methods and under a variety of conditions. Though it has been known that culture techniques can affect what kind of cells PSCs eventually become, no "gold standard" has yet been established to help scientists determine how the artificial environment can better replicate that found in a natural state (in vivo).

Dr. Kevin Huang, postdoctoral fellow in the lab of Dr. Fan and a lead author of the study, analyzed data from multiple existing research studies conducted over the past year. These previously published studies used different culture methods newly developed in vitro in the hopes of coaxing human stem cells into a type of pluripotency that is in a primitive or ground-zero state.

Utilizing recently-published gene expression profiles of human preimplantation embryos as the benchmark to analyze the data, Dr. Huang and colleagues found that culture conditions do affect how genes are expressed in PSCs, and that the newer generation culture methods appear to better resemble those found in the natural environment of developing embryos. This work lays the foundation on the adoption of standardized protocol amongst the scientific community.

"By making an objective assessment of these different laboratory techniques, we found that some may have more of an edge over others in better replicating a natural state," said Dr. Huang. "When you have culture conditions that more consistently match a non-artificial environment, you have the potential for a much better reflection of what is going on in actual human development."

With these findings, Dr. Fan's lab hopes to encourage further investigation into other cell characteristics and molecular markers that determine the effectiveness of culture conditions on the proliferation and self-renewal of PSCs.

"We hope this work will help the research community to reach a consensus to quality-control human pluripotent stem cells," said Dr. Fan.

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UCLA Scientists Propose Benchmark to Better Replicate Natural Stem Cell Development in the Laboratory Environment