Position of the California Stem Cell Agency on Gene-Edited Babies? No Go.

California's $3 billion stem cell agency may be on the leading edge of regenerative medical research, but it is clearly opposed to the type of work that has led to the international flap over the gene-edited babies in China. 

Its regulations have long barred that sort of experimentation. In 2016, the agency, known formally as the California Institute for Regenerative Medicine (CIRM), convened an international conference to discuss the issues involved.

The session in Los Angeles went on for hours, generating a 223-page transcript touching on the difficulty of regulating gene editing, among a host of other difficult issues. 

One patient advocate in the audience, Adrienne Bell Cors Shapiro, noted that it is nearly impossible to control all that might happen. She said,  

"People are messy. And if you develop this technology, somebody is going to find a way to use it."

Last week the MIT Technology Review published an article about a Stanford University investigation into what two of its researchers knew about the Chinese research. The scientists also have received CIRM funds for research unrelated to the Chinese work. 

Asked for a comment, a spokeswoman for the state stem cell agency said in an email:

"CIRM’s regulations prohibit nuclear genome editing for reproductive purposes. In February 2016, CIRM convened the Scientific and Medical Accountability Standards Working Group (SWG) for a workshop on Human Gene Editing. The SWG subsequently recommended that no changes be made to CIRM’s existing prohibition on nuclear genome editing for reproductive purposes."

In 2016, Hank Greely, a law professor at Stanford who deals with bioethical issues, told the gene editing conference:

"CIRM is in the human embryo experimentation world. It funds research as long as the embryos are not implanted. It funds it with special protections and special review considerations and special informed consent considerations. I don't think CRISPR-cas9 changes that."

The controversial research in China triggered a global uproar in the scientific community. The leading stem cell research organization, the International Society for Stem Cell Research, issued a statement opposing such experimentation. 

He Jiankui, the Chinese scientist who performed the experiment, has lost his job in that country, according to news reports, and may be facing criminal charges. His work has not been confirmed by an independent review. 

Meager California Biotech Representation in Governor's China Trip

California Gov. Jerry Brown and a flying squad of business types visited China last week, beating the drum for the Golden State in an effort to raise billions of dollars in investments.

Some 90 persons were involved in the governor's delegation, but representation was meager from California's renown biotech sector and none at all from the $3 billion California stem cell agency, which has a collaboration underway with Chinese scientists. It may have been the only state agency with a formal collaboration agreement with China prior to Brown's visit.

According to many reports, the Chinese government regards growth of its biotech industry as one of its core economic efforts. Within that sector, biomedicine ranks as the most important and fastest growing, according to an Italian Trade Commission report. Stem cell research is especially important, according to this Canadian study. Indeed, some scientists in China are eyeing a Nobel Prize in the field (See here or here.)

California would seem to be well placed to take advantage of that situation, given its substantial biotech industry and community, which is only rivaled by Massachusetts. Add to that the existence of the unique California stem cell agency, which has funded a $1.5 million study by Holger Willenbring at UC San Francisco that also involves research by Lijian Hui at the Shanghai Institutes for Biological Sciences, which is separately funded by that country to the tune of nearly $1 million.

A look at the list of those traveling to China with the governor showed two representatives who could be considered from biotech: Joe Panetta, head of BioCom, a life science industry organization in Southern California, and Michel Baudry, dean of the Graduate College of Biomedical Sciences, Western University of Health Sciences in Pomona, Ca..

We queried Baudry before he left for China about the situation. Here is the full text of his reply.

“I do not know how this set of delegates were selected. What I do know is that this is the first of several delegations of California business delegates going to China with Governor Brown, and that more trips are scheduled. The focus of this first trip is Energy and Environment, and this might be why there is no biotech delegates in this trip. I am quite sure that they will participate in the following trips.”

Meanwhile, the folks in Richmond on San Francisco Bay are waiting to hear about plans of a major but unnamed Chinese biotech company for the 53-acre, former Bayer Healthcare Campus.

(Following the posting of this item, Ron Leuty of the San Francisco Business Times gave us a heads up on the latest on the site. He reported in March that Joinn Laboratories, a Chinese contract research organization, purchased the site. Leuty said that its plans are vague about future development, but that it may lease some of the space.)

The Stem Cell Race: Underdogs, Singapore's Biopolis, China and the UK

The San Diego Union-Tribune Sunday began a three-part series on embryonic stem cell research globally, reporting that the United States is "getting a taste of being the underdog."

Reporter Terri Somers, who has followed the industry and the California stem cell agency from San Diego's biotech hotbed, also wrote a Sunday piece looking that the business side of the research.

Both Sunday articles are as comprehensive on their subjects as one is likely to see in the mainstream media. Included is a downloadable world map with country-by-country snapshots.

Here are some excerpts from the front page series called "The Stem Cell Race:"

"'For the first time, we have a lot of competition ... . I don't think we've had as much concern for another country besting us in science since the race to the moon,' said Dr. Evan Snyder, who runs the embryonic stem cell research program at the Burnham Institute in La Jolla.

"It is a competition with crucial consequences for San Diego County and California, home to leading stem cell researchers and 50 percent of the world's biotechnology research."

Somers continued:

"China reportedly is doubling its investment in stem cell research. But an air of mystery and skepticism surrounds China's work, because the country's regulatory guidelines differ from those in the West and because research from Chinese scientists has not been widely published.

"The United Kingdom already has invested about $198 million in stem cell research at 90 laboratories, of which 11 are licensed to conduct human embryonic stem cell research.

"Singapore, with just 4 million citizens, is investing $25 million to $29 million annually in research, excluding overhead costs and infrastructure.

"That investment may seem wimpy compared with the $609 million the United States government spent on stem cell research last year. But because of federal funding restrictions on human embryonic stem cell research, only $20 million to $40 million a year – about 6 percent at best – has been directed to that field.

"Money is not the sole catalyst of success. Scientists say supportive government policies that free them to concentrate on their work, national commitment and contagious scientific enthusiasm are just as important.

"'Here we are again, sitting on the beginning of another revolution, a possible way to provide cures rather than treatments," said Chris Mason, a stem cell researcher at University College London. 'The U.K., Singapore and other countries realize what might be within their grasp if they spend the money on the front end, and they don't want to miss it.'

"The United States, long the world leader in biomedical research and commercialization, is getting a taste of being the underdog."

Somers' piece on the business of stem cells said:

"Worldwide, only about a dozen companies are building a business based on human embryonic stem cells, and only three of those are publicly traded: Geron in Menlo Park, Advanced Cell Technology in Alameda and Stem Cell Sciences in Edinburgh, Scotland.

"Executives at several of the companies say the key to tapping funds at such an early stage is either finding someone with deep pockets and a personal passion for curing disease or possessing a unique technology to address a potentially huge market.

"Given the current business climate and the political and moral debate surrounding human embryonic stem cells in the United States, people in the business don't expect more competition to pop up soon."

On Monday, Somers will look at Singapore and its "Biopolis."