California Regulators Fleshing Out Details of Hearing on Regulation of Rogue Stem Cell Clinics

California state regulators have posted the line-up for a meeting later this month to deal with rogue stem cell clinics that peddle "snake oil" treatments that have led to injury and financial loss.

The meeting comes as Google announced this week that it is cracking down on advertising involving the dubious clinics. Also this week, the president of the largest group of stem cell researchers in the the world warned of the dangers of unproven treatments. 

Deepak Srivastava, president of the Goldstone Institutes in San Francisco and leader of the International Society for Stem Cell Research, said the promises of the largely unregulated clinics "aren’t true--they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public."

The state Medical Board scheduled its meeting for Sept. 18 in Sacramento as a precursor to possible regulation of the activities of medical professionals at the clinic.

Scheduled to testify are Maria Millan, president of the $3 billion state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), and Mehrdad Abedi of UC Davis, a physician, cancer specialist and stem cell researcher. 

Abedi is a key figure in UC Davis' Alpha Clinic, which is designed to coordinate and sharpen the focus of clinical stem cell research and treatment. 

Also scheduled to appear are representatives of the State Department of Public Health. The meeting is scheduled to be available via the Internet. The public can attend and comment at the session. 

The medical board said earlier that another session may be scheduled later this fall. Recommendations for regulations could come to the full medical board in January. See here for more details on the board's plans.

New Warning on Shady Stem Cell Clinics that Prey on Desperate Patients; California Hearing Coming Up

The head of the largest organization of stem cell scientists in the world this week spoke out about rogue stem cell clinics that are fleecing and endangering desperate patients. 

Deepak Srivastava
Gladstone photo

Deepak Srivastava, president of the International Society for Stem Cell Research and president of the Gladstone Institutes in San Francisco, said advertisements and pseudo news articles are promising cures for everything from autism to cerebral palsy.

"The claims simply aren’t true--they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public," Srivastava wrote on the web site of the Scientific American.

The headline on his article said, 

"Don’t Believe Everything You Hear about Stem Cells

"The science is progressing rapidly, but bad actors have co-opted stem cells’ hope and promise by preying on unsuspecting patients and their families"

The piece comes as California is preparing to take another step in regulation of the clinics, which have burgeoned across the nation.  Estimates are that the number of clinics exceeds 1,000 with the California having the largest share. 

The state Medical Board has scheduled a hearing on the clinics Sept. 18. The head of the state's $3 billion stem cell agency, Maria Millan, is slated to testify among others. Members of the public may testify as well. The Sacramento hearing will be broadcast on the Internet. 

(About eight hours after this item was published, the Medical Board board posted its agenda for the meeting.)

UC Davis stem cell scientist Paul Knoepfler and Leigh Turner of the University of Minnesota were the first to chronicle the scope of the dubious clinics. Knoepfler wrote this week about a follow-up study that he has published that showed that regulators have a whack-a-mole problem. 

Knoepfler said that his study "indicates that stem cell clinics are in general a fairly rapidly-changing type of business and many disappear or change over a few years. This makes overseeing this clinic industry harder for (regulators)." 

Both state stem cell agency and the international stem cell  group, which has more than 4,000 members in 60 countries,  provide information aimed at helping patients separate legitimate stem cell activities from bogus ones. Here is a link to the ISSCR advice. Here is a link the state stem cell agency's information. 

Kaiser Healthline: California's Stem Cell Program Short on Cash and Cures

An overview by Kaiser Healthline of California's nearly 15-year-old stem cell research program received attention in California and nationally last month. 

"Despite Failed Promises, Stem Cell Advocates Again Want Taxpayers To Pony Up Billions" said the headline on the article by Ana Ibarra.

Her piece carried both positive and negative comments on the performance of the $3 billion agency, which is running out of cash for new awards. The enterprise hopes voters will approve in November 2020 another $5.5 billion to continue its work.

The article quoted Marcy Darnovsky, executive director of the Berkeley-based Center for Genetics and Society, a longtime critic of the agency, which was created through a ballot initiative campaign in 2004. 

Darnovsky said that if the agency, known formally as the California Institute for Regenerative Medicine (CIRM), is measured against the campaign promises, “then CIRM has been a flop.”  

The agency, however, pointed to its 56 clinical trials, along with the stories of patients who have benefitted from that research, ranging from children who are alive today as the result of experimental treatment to spinal cord injury victims who are seeing their lives improve. 

Ibarra's article was picked up nationally by Salon. Politico noted it in its California newsletter.  The Sacramento Bee, the only daily newspaper in the state capital, published it as well.  

Webinar on Navigating FDA Stem Cell and Regenerative Regulations

Confused about federal regulation of stem cell therapies? That is the question being asked this morning by a Washington, D.C., law firm that plans to try to provide answers later this month.

The firm, Buchanan Ingersoll & Rooney, said it will stage a webinar on Sept. 17 to explain Food and Drug Administration "regulations and enforcement, and how stem cell stakeholders (pharma/biotech companies, healthcare providers) can best comply."

Fees for the session range from $287 to $487. More information can be found here.  

Brain Cells in Space Backed by Millions from the California Stem Cell Agency

UC San Diego video

The New York Times is carrying a piece today about a San Diego stem cell scientist and a project that involves "brain cell blobs" growing "like crazy" in space.  

The researcher is Alysson Muotri of the University of California, San Diego, who is trying crack some of the mysteries of brain development and mental disorders. His space cell project has been supported by $2.1 million from California's $3 billion stem cell agency along with other funding. 

Muotri is a brain organoid man, so to speak. Muotri and his team grew clusters of cells called brain organoids and sent them into space in July with the help of NASA to see how they would develop in zero gravity. 

Carl Zimmer of the New York Times wrote 1,000 words about the experiment. This morning his piece was on the front page of the Times website with this headline: "These brain cell blobs are growing 'like crazy' in space." 

"What, exactly, are they growing into?" Zimmer's article asked. "That's a question that has scientists and philosophers alike scratching their heads."

"As the organoids mature," Zimmer wrote, "the researchers also found, the waves change in ways that resemble the changes in the developing brains of premature babies."

Zimmer quoted Giorgia Quadrato, a neurobiologist at USC who was not involved in the study, on the subject:

“It’s pretty amazing. No one really knew if that was possible.”

The Times piece continued,

"But Dr. Quadrato stressed it was important not to read too much into the parallels. What she, Dr. Muotri and other brain organoid experts build are clusters of replicating brain cells, not actual brains.

“People will say, ‘Ah, these are like the brains of preterm infants,’ she said. 'No, they are not.'"

California's stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), has plowed a total of $5.2 million into Muotri's research, which investigates fundamental mechanisms of brain development and mental disorder. 

In response to a query, Muotri told the California Stem Cell Report:

"CIRM funding was used on this last work to optimize the brain organoid protocol. We used this tool in our last two grants, including the one on Zika virus. So, thankfully to CIRM we now have a reproducible and more robust protocol.

"I think the importance and potential impact of this study is quite significant. We can now model neurological and psychiatric conditions that are caused by defects in the network. All previous brain organoid protocols couldn’t get to this level of activity."

Of Muotri's four CIRM grants, two totalling $2.1 million came into play in connection with the space organoids. One of the awards, DISC2-09649, involved Zika and human neurodevelopment. The other, DISC1-08825, dealt with neuroinflammation, a significant component of neurological disorders, including autism, ALS, Parkinson, Alzheimer, lupus, multiple sclerosis and aging.

Muotri's work has led him to co-found a firm called Tismoo, which is developing therapies involving autism spectrum disorder and other neurological disorders with genetic origins.

Muotri's space organoids also triggered a number of news articles. One by Sharon Begley of STAT carried this headline,

"In a first, cerebral organoids produce complex brain waves similar to newborns’, reviving ethical concerns."

Here is a link to a lengthy release from the UC San Diego wth a headine saying,

"AI Algorithm Can’t Distinguish These Lab Mini-Brains from Preemie Babies"

Here is what CIRM had to say this morning about Muotri's research on the agency's blog, The Stem Cellar. 

"These new organoids allow us to explore how new therapies might work in the human brain, and hopefully increase our ability to develop more effective treatments for conditions as varied as epilepsy and autism."

How Muotri might translate brain cells in space into therapies for such things as autism is yet to be determined. But there is little doubt that his latest results will draw increased attention nationally and internationally in the coming months.

(Editor's note: The information about CIRM's blog was not contained in earlier versions of this item.)