LA Times on Stem Cell Video Flap: 'Infomercial,' Hype and How the Hooha All Began

The Los Angeles Times this afternoon reported on the uproar over a stem cell video has left some researchers across the nation incensed and calling the film an "infomercial" that ballyhooed unproven therapies.

Twelve scientists and other experts have asked to be removed from the video that was partly financed by a California firm that is being sued federal regulators to halt the potentially dangerous treatments.

The Times piece was authored by Pulitzer Prize-winning columnist Michael Hiltzik who has written previously about the unregulated stem cell industry. He said,

"If there’s anything that drives legitimate stem cell scientists up a wall, it’s their being lumped in with clinics offering unwary customers supposedly effective disease treatments through stem cell injections."

The firm that helped fund the "Healthcare Revolution" is Cell Surgical Network, which is based in Southern California but has 100 affiliates across the country and more overseas. The Food and Drug Administration has sued the firm to halt the use of what it calls unproven and potentially dangerous treatments. 

The film was produced by Bobby and Sara Sheehan over the period of about a year. Hiltzik wrote,

“'It’s a package that’s very misleading and not balanced,' says Evan Snyder of Sanford Burnham Prebys Medical Discovery Institute. 'It was pitched like it would be a ‘Nova,’' he said, referring to the scientific series produced for the Public Broadcasting System, 'but it came out like an infomercial.' 

"Lawrence S.B. Goldstein of UC San Diego says he was led to believe the producers were making a 'balanced, sober documentary.' The trailer for the series posted on its website, however, was infused with hype—'It sounded like miracle cures from stem cells are here today—‘Give us your money and we’ll fix you up,’ giving false hope to people suffering from terrible diseases.'”

The Times piece laid out how the flap erupted just days before the video was to begin today. Hiltzik wrote,

"It was only last week that the true nature of the project emerged. That’s when Cell Surgical Network sent customers and former customers an email announcing the documentary’s upcoming premiere. The email landed in the in-box of Doris Tyler, a Florida resident who is suing Cell Surgical Network and affiliates for allegedly leaving her blind via a stem cell treatment for an eye condition.

"Tyler alerted her attorney, Andrew Yaffa, who passed the alarm on to Loring at Scripps. Loring scanned the documentary’s website and noticed that she and numerous academic colleagues were featured along with purveyors of unproven treatments. On June 13, she says, “I sent messages to everyone I knew” on the roster of participants.

"Subsequently, Sheehan disclosed that Cell Surgical Network had partially funded the series, deepening the alarm and prompting most, if not all, the academic participants to withdraw. 

“That was the kiss of death for me,” Loring told me. “I do not want to be associated with those guys at all.'”

Loring said in a letter to the Sheehans,

 "You have placed my interview among those of people who are charlatans and thieves...."

Stem Cell Video Flap: CEO of California Stem Cell Agency Backs Out of Internet 'Docu-Series'

The president of the $3 billion California stem cell agency has removed herself from a controversial online video that placed her in the electronic company of leaders of firms targeted by federal regulators.

In an email early today to the producers of the lengthy video, Maria Millan referred to an appeal for her to reconsider her previous request to back out of the "docu-series."

"I am not swayed by the letter from Mark Berman of Cell Surgical Network and, in fact, it deepens my concern. I maintain the same position and concerns expressed in my note dated June 15. Please remove my interview from the documentary and my picture and name from any associated materials —including this link- please remove me as an “episode expert” on https://www.healthcarerev.org/?inf_contact_key=efe318f527b6ecd43046adebf597cfd9."

The video, titled the "Healthcare Revolution" was partly financed by Cell Surgical Network, which has offices in Beverly Hills and Rancho Mirage, Ca., plus about 100 affiliates nationwide. The Food and Drug Administration(FDA)has sued the firm to halt what the FDA says are unproven and potentially dangerous treatments.

A number of researchers and others pictured in the video have also asked to be removed, saying they were misled about how their interviews would be used. San Diego-area stem cell researcher Jeanne Loring declared that being in the video placed her among "charlatans and thieves" who prey on desperate patients.

Kevin McCormack, senior director of communications for the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known, explained what led to the agency's involvement with the video producers, Bobby and Sara Sheehan. In response to questions from the California Stem Cell Report, McCormack said, 

"When the Sheehans asked us to be part of the series we looked at previous work they had done and reviewed the questions they wanted to ask. We knew they were going to talk to a wide range of people for the series but we were sufficiently reassured that we initially agreed to the interviews feeling it was important to have our voice heard.

"However, once we learned who was partially funding the project and saw the trailer we felt it risked giving a distorted view for anyone who saw it and that it inadvertently legitimized opportunistic, bad actors. It’s unfortunate these so-called 'clinics' are trying to hijack the reputation of legitimate stem cell therapies and cash in on scientists who are doing serious, scientifically sound research....

"I think the fact that virtually all of the highly regarded scientists interviewed for the series have withdrawn from it, people like UC San Diego’s Larry Goldstein and Scripps Jeanne Loring, says everything that needs to be said. None of us who have spent years warning the public about the dangers of going to clinics offering unproven and unapproved stem cell therapies want anything to do with something that equates FDA-sanctioned clinical trials with unsanctioned and unregulated stem cell therapies."

The flap over the video comes as the number of dubious stem cell clinics is estimated to exceed 1,000 nationally, with the highest percentage in California. The state has been slow to regulate the clinics whose treatments have reportedly led to illness and blindness. Legislation aimed at the clinics is all but dead in the legislature, leaving the regulation solely in the hands of the state Medical Board. 

The board said today that it has no authority over clinics -- only physicians. The board has been mulling over the matter for about 11 months. But its two-person "task force" has yet to schedule a public meeting.  

California State Medical Board Says it Has No Authority to Regulate Dubious Medical Clinics

The California state Medical Board wants to make it clear that it does not regulate stem cell clinics -- only physicians. 

An email from its spokesman this morning said it is concerned that readers might misunderstand an item on the California Stem Cell Report last week dealing with the pace of state regulation of "snake oil" enterprises.

Carlos Villatoro said,

"I would like to request a correction/clarification in your story. The Board does NOT regulate stem cell clinics and has no authority take ANY action against stem cell clinics. "The Board’s sole jurisdiction lies in the physicians who work at the clinics, who may or may not be performing stem cell procedures.   The statement in your story,  'A spokesman for the California Medical Board, Carlos Villatoro, said this week that a task force of the board is expected to hold its first meeting this summer to deal with stem cell clinics,' is inaccurate and we are concerned that your readers will think that we regulate stem cell clinics, which we do not. "The Board would appreciate a correction/clarification. Please let me know if you have any further questions."

In a response to Villatoro, David Jensen, publisher of the California Stem Cell Report said, 

"Thank you. I will run a separate item containing your email comments. The board's position is important and significant. However, I do not think a correction is necessary. The clinics are mostly run by physicians. 'Dealing' with clinics means dealing with those who run them, i.e., physicians. I would glad to discuss this with your executive director or the chair of the board if you wish. Thanks."

Stem Cell Video Flap: World Stem Cell Summit Withdraws from 'Docu-Series'

The chairman of the World Stem Cell Summit today said that he has asked that his organization be removed from any mention in a controversial online video about stem cell therapies.

Bernard Siegel, chair of the Summit, said,

"My organization's stand on the 'Bad Actors' is clear from the numerous posting and interviews. We support the FDA in enforcement actions and condemn the actions of the purveyors of bogus treatments, false and misleading claims."

Siegel's remarks came in response to questions this morning from the California Stem Cell Report. He said that he also asked that his interview be withdrawn from the 10-part "docu-series." Some of interviews that appear in the video were done at one of the Summit conferences. 

A number of researchers and others have also asked that they be removed the video, "Healthcare Revolution," because of its ties to a California stem cell firm, Cell Surgical Network (CSN), that is the target of federal regulators. The CEO of the California stem cell agency is also listed as an interviewee in the video. 

Siegel said that the World Stem Cell Summit has no financial connection to CSN, which partially financed the video. He also said the Summit had no financial ties to Working Pictures, the firm that produced the video or its principals, Bobby and Sara Sheehan.

The Food and Drug Administration (FDA) is seeking to halt treatments provided by CSN, which has about 100 affiliates nationwide and more overseas.  CSN has offices in Beverly Hills and Rancho Mirage, Ca. (For more information on the FDA action, see here and also here.

Here is the full text of Siegel's response to the California Stem Cell Report.

"The Sheehans appeared to be, by all accounts, legitimate filmmakers with a long track record of quality productions. They did film several interviews at the World Stem Cell Summit for their documentary. The Summit team was unaware of any links the production had with Cell Surgical Network. We were surprised last week when the trailer was released and saw how the series was being framed promotionally.

"The Summit, or any other organization that I am affiliated with, certainly has no connection to the Cell Surgical Network financial or otherwise. Upon learning that CSN funded the production, I withdrew my own interview from the project and requested the removal of any reference to my organization.

"We have no financial ties to the Sheehans or their production company. I have spoken to Sara and Bobby Sheehan who instantly agreed to remove any individual who sought to remove his or her interview from the series. They have proven themselves totally cooperative to date in that regard. They appear to be caught in the middle of a war, unfortunately lacking the depth of understanding.

"My organization's stand on the 'Bad Actors' is clear from the numerous posting and interviews. We support the the FDA in enforcement actions and condemn the actions of the purveyors of bogus treatments, false and misleading claims."

Stem Cell Video Flap: California Firm Asks Concerned Scientists to Reconsider Requests for Removal

This is a clip from the web site for the video "The Healthcare Revolution."

More details emerged late today about a controversial Internet video backed by a California stem cell firm that is being sued by federal government to halt what allegedly are "unproven and potentially dangerous treatments."

The video features the CEO of the $3 billion stem cell agency, Maria Millan, and more than 80 other researchers and academics. The video website displays logos of academic institutions ranging from Stanford to the University of Cambridge. The site says the video will reveal that "stem cell technology that is said to be 10, 20, years down the road is actually here – NOW!"

Some of the researchers who appear in the video have asked to be removed because of its connection to Cell Surgical Network(CSN), which has offices in Beverly Hills and Rancho Mirage, Ca. The firm said it has funded a portion of what it called "this important docuseries." CSN today asked concerned scientists to reconsider their requests. 

CSN has been sued by the Food and Drug Administration to  halt its treatment practices.

Jeanne Loring, professor emeritus from Scripps Research, is one of those scientists whose remarks were carried in the video. In an email, she said she only learned that she was in the video last week. The recording of her came from an interview that she did at the World Stem Cell Summit. 

Loring has been a longstanding foe of unregulated stem cell clinics. She wrote the producers of the video, Sara and Bobby Sheehan:

"As I have explained many times, to print reporters, community groups, and in video interviews, as a scientist with a moral compass, I cannot condone exploitation of desperate people who are led to believe that they will be cured or even helped by a clinic or a pill or any purported therapy that is not based in science.... 

"You have placed my interview among those of people who are charlatans and thieves, and I request that you remove all reference to me in the video and on your website." 

(See here for the full text of Loring's letter.)

The firm initially granted Loring's request but then late today appealed to her to change her mind. Loring refused. 

In her email today to Loring, Sara Sheehan cited a letter sent out today to "concerned stem cell scientists and doctors" by Mark Berman, co-founder of Cell Surgical Network. It appeared to be addressed to other researchers filmed for the video. 

Berman said his firm made "no effort to control (the) production" of the video. 

Berman told the researchers,

"Personally, I think a lot of the participants who want to drop out know little and/or nothing about the work CSN has been doing worldwide. They do not know about some of the amazing basic science research we have funded, nor do they know about the hundreds of patients that we have treated at no cost and hundreds at markedly reduced rates including dozens of patients that have had multiple deployments at no cost."

(The full text of Berman's letter can be found here.)

Text of Loring Letter Asking to be Removed from Stem Cell Video

Here is the text of email that stem cell scientist Jeanne Loring sent to Sara Sheehan in connection with the controversial "HealthRevolution" documentary. 

​"Dear Sara:
"When I was interviewed at the World Stem Cell Summit, I was misled about the context in which my interview would be placed. I was told that it would be an educational video about the progress of legitimate stem cell therapies.

"I am a staunch and outspoken opponent of clinics that flout the FDA regulations for stem cell treatments, and have met many people who have paid many thousands of dollars to obtain unregulated (and therefore unsafe) treatments that claim that stem cells will magically cure any disease.

"As I have explained many times, to print reporters, community groups, and in video interviews, as a scientist with a moral compass, I cannot condone exploitation of desperate people who are led to believe that they will be cured or even helped by a clinic or a pill or any purported therapy that is not based in science.

"I know you are young, but this is equivalent in history to the Laetrile scam of the 1970s. Thousands of desperate people emptied their wallets and obtained this alleged therapy before the FDA stepped in and banned it. Many were crushed and bankrupt; some died.

"'Stem cell' clinics are worse, because they can market their useless and dangerous products to a far larger audience.

"FDA leaders Scott Gottlieb and Peter Marks have denounced these unregulated clinics as “bad actors”, and I would go further - I think they are criminals.

"I use pluripotent stem cells to generate real cell types to replace cells that have died in disease. I have not seen any evidence that extracts from fat, or bone marrow, or products derived from placentas and umbilical cords have any medical value.

"You have placed my interview among those of people who are charlatans and thieves, and I request that you remove all reference to me in the video and on your website.

"I understand that you are good and honest film makers, so this should not be a difficult request. Please respond that you have removed me and I will not trouble you further."

"Sincerely,
"Jeanne Loring"

Text of Cell Surgical Network Letter re "Healthcare Revolution" video

Here is the text of the letter sent out today to scientists and others who were concerned about appearing in a controversial video about stem cell therapies.

   Letter from Cell Surgical Network re "Healthcare Revolution" video by Anonymous 2ZGCBei on Scribd

Stem Cell Researchers Backing Away from Documentary Touting 'Greatest Paradigm Shift in Medical History'

What do Maria Millan, CEO of the $3 billion California stem cell agency, Larry Goldstein of UC San Diego, Thomas Murphy of Harvard/MIT  and Mark Berman of Cell Surgical Network have in common this morning?

They are all loosely listed as "trusted sources" on a website ballyhooing a 10-part documentary involving stem cells. All are identified as taking part in the documentary. Berman's firm, however, is a target of the Food and Drug Administration, which is seeking to halt the enterprise's "unproven and potentially dangerous treatments." 

Erin Allday of the San Francisco Chronicle reported on the connections in a story this weekend that said some of the scientists involved in the documentary, scheduled to be released tomorrow, want out of the online video because it is partly funded by Berman's firm. 

The documentary is titled "The Healthcare Revolution." The Internet address of Berman's firm is stemcellrevolution.com."  It also offers a book called "The Stem Cell Revolution." The business has offices in Beverly Hills and Rancho Mirage, Ca., and is linked to reportedly dozens of similar enterprises.

Allday quoted Berman as saying in an email to patients last week,

“We have a wonderful docuseries coming out. It’s a whole production, not just about us. It’s going to enlighten people."

The website of the documentary features ebullient language about stem cells. "Stem cell technology that is said to be 10, 20 years down the road is actually here --  NOW!" reads one sentence on the video site.  The largest headline on the site said in bold red type, 

"This Must See Documentary Series Unveils the Greatest 
Paradigm Shift in Medical History"

Allday's story said some of the scientists involved in the documentary now say "they weren’t aware of who was backing the project when they agreed to participate...Some scientists said they fear the documentary may promote what they consider junk science."

Allday continued, 

"In fact, many of the scientists listed on the website have said repeatedly that stem cell therapies are still years away from being ready for patients. They have said that the hundreds of providers treating patients at for-profit clinics are selling 'snake oil' products that are worthless and potentially unsafe. No stem cell therapy currently sold at for-profit clinics has been approved by the FDA."

The Chronicle article said the California stem cell agency did not know who was financing the documentary when it agreed to participate.  A spokesman for the agency, known formally as the California Institute for Regenerative Medicine, told Allday that the agency agreed to participate because it would provide an opportunity to promote its work and warn against dubious clinics. 

One scientist who was scheduled to appear in the documentary is Jeanne Loring, professor emeritus at Scripps Research in La Jolla. She told Allday, “I am a stalwart and outspoken critic of unapproved stem cell therapies. I don’t belong in their company."

She said the producers of the video agreed to remove her from the documentary. 

More than 80 physicians and scientists are listed as "trusted sources" or experts on the video website along with a number of major academic institutions, including Stanford, Harvard, John Hopkins, Yale and Oxford.  Also listed is Kristin Comella, chief scientific officer of U.S. Stem Cells, Inc., which earlier this month lost a key ruling in lawsuit filed by the FDA against it. 

California's Slow Pace on Stem Cell Snake Oil: State Medical Regulators May Take First Stab This Summer

California regulation of an industry that sells dubious and risky "stem cell" treatments now appears to be solely in the hands of the state Medical Board, which has been mulling the matter for at least 11 months.

Both nationally and in California, the number of unregulated clinics has risen sharply with estimates of more than 1,000 nationwide, with the largest number in California. 

Jonathan Thomas, chairman of the $3 billion state stem cell agency, has described the fast-growing clinics as snake-oil enterprises.

The clinics peddle what they call stem cell treatments to desperate patients. The treatments cost thousands of dollars. Some patients have reported losing their vision as a result. Last December, the federal government reported that 12 persons were hospitalized because of infections from treatment by a California clinic. Some of the material involved was contaminated with fecal bacteria.

The New York Times reported this week that across the nation the clinics have "attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures." The Times piece echoed a bleak national picture that was painted earlier by the Washington Post. 

A spokesman for the California Medical Board, Carlos Villatoro, said this week that a task force of the board is expected to hold its first meeting this summer to deal with stem cell clinics. "The task force should be meeting soon and potentially holding an interested parties meeting, hopefully before the next board meeting," he said in an email to the California Stem Cell Report.

The next board meeting comes in August. The task force consists of two members of the state board:

Randy Hawkins, LA Sentinel photo

Randy Hawkins of Los Angeles, who is a clinical assistant professor of medicine at the Charles Drew University of Medicine and Science in Los Angeles, and Howard Krauss of Santa Monica, Ca., who is a clinical professor of ophthalmology and

Howard Krauss, PNI photo

neurosurgery at the John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica. 

State legislation to deal with the burgeoning problem is moribund and may or may not be resurrected.

Art Torres, vice chairman of the board of the California stem cell agency, has been working on the measure (AB617). He served for 22 years in the state legislature and is a former head of the California Democratic Party. 

Last month, Torres described the stem cell clinic measure as "dead." He said the reasons for its demise are "unclear," along with the failure of another bill dealing with sickle cell disease. Torres told the board, 

"They haven't told us why they opposed it, and even the author of the bills can't figure out why their bills remained in what's called the suspense file of the Assembly Appropriations Committee."

Torres later told the California Stem Cell Report that it was possible that the content of the bill could be amended into another measure that is farther along in the legislative process. But he said that no clear pathway to final passage was evident. 

In New York, the state attorney general has charged one stem cell clinic with fraud. In California, Attorney General Xavier Becerra has remained mum on the subject. 

Captain Kirk, Snake Oil and Stem Cell Treatments

It's time for stem cell whack-a-mole.

That's the game where regulators -- coming in late -- try to prevent snake-oil clinics from harming desperate patients with purported stem cell treatments and ripping off them for thousands of dollars.  

More than 1,000 dubious clinics are estimated to exist across the country with the largest number in California, which is lagging in its regulatory efforts.  More spring up every day with even Captain Kirk of Star Trek weighing in on the alleged benefits of the unregulated procedures.

William Wan of the Washington Post captured the national scene in an article late on Friday. He said don't get too excited about a favorable court decision involving one operation in Florida, which claims to turn body fat into beneficial stem cells.

Wan wrote,

"(T)he company said it would follow the federal judge’s ruling and stop selling the fat-based procedure. But it quickly followed up with a clarification: It would continue offering stem cell treatments, but instead of fat, rely on patients’ bone marrow and other tissues to harvest the cells it claims can cure conditions as varied as spinal cord injuries and erectile dysfunction.

"'It’s a bit like playing whack-a-mole,' said Peter Marks, FDA’s top official for biologic products."

The situation has been building for long time. Wan wrote,

“After years of largely ignoring the issue, the FDA is finally making more of an effort, but it’s not as if this marketplace is melting away,” said Leigh Turner, a bioethicist at the University of Minnesota. 

"Because no one had documented exactly how many stem cell clinics existed, Turner — working with collaborators (UC Davis researcher Paul Knoepfler) — began tracking them in a database several years ago. In 2009, there appeared to be only two in the United States; by 2017, there were at least 700. Turner believes there are currently more than 1,000."

"Turner compared the for-profit stem cell industry to a balloon. As the FDA and consumer advocates squeeze one end, other parts of the enterprise expand. 'For every one that’s disappeared, we’re finding seven more that are popping up.'"

Wan noted another effort in California that could affect a number of clinics. 

"Meanwhile, the government is pushing forward in a second federal court lawsuit against another stem cell business in California. That lawsuit has the potential to halt the fat-based stem cell treatment in multiple clinics because the government filed it against a company called Cell Surgical Network, which serves as an umbrella for dozens of affiliated clinics around the country."

An attempt to step up state regulation in California, however, has ground to a halt. Legislation (AB617) by Assemblyman Kevin Mullin, D-San Mateo, is now not even on life support. It is buried in the Assembly Appropriations Committee. Its content could surface in another measure that still has some technical life in the Capitol, but the outlook is more than dim. 

The scene is not much brighter with California's medical board. Last year said it would look into the dubious clinics. In April, it said hearings might begin no later than early this month. Nonetheless, a check of the agency's web site this weekend did not turn up any notice of such a meeting.

Trump Research Restrictions, the California Stem Cell Agency and Moral Obligations

The man expected to lead the drive for $5.5 billion more for California's stem cell agency today said the Trump restrictions on fetal tissue research represent a dangerous precedent that threatens the health of all Americans. 

Robert Klein, who was the first chairman of the state stem cell agency, said that "California has unique opportunity and obligation to maintain the scientific and medical options" that have led to development of the polio vaccine along with many others.

During an interview with the California Stem Cell Report, Klein said the people of California have a "moral" obligation to add more billions to the work of the 14-year-old, $3 billion stem cell agency.

Klein led the 2004 ballot initiative campaign that created the agency, formally known as the California Institute for Regenerative Medicine (CIRM).  The agency expects to run out of cash for new awards by the end of this year. It is staking its existence on a proposed ballot initiative that Klein would carry forward.

Klein's comments came as more reaction surfaced to the Trump action. San Francisco HIV advocate Jeff Sheehy, responding to a question, said in an email,

"Fetal tissue is used to make mice with human immune systems.  Testing new drugs for HIV is just one use--this animal model is used in research across a wide range of diseases to develop and test therapies, including vaccines for infectious diseases.  Stopping this research--which has been taking place for decades--is foolish, anti-science, and a threat to the health and safety of all Americans."

Kaiser Health News reported,

"The Trump administration’s announcement Wednesday about federal cutbacks in fetal tissue research is short of a total ban, but scientists in the field say it is concerning because it could affect work on treatments or preventions for key diseases, such as HIV and Parkinson’s."

Sara Reardon, reporting online for Nature, wrote,

"'It’s a decision that’s going to set back research,' says Andrew McMahon, a stem cell biologist at the University of Southern California in Los Angeles. 

"McMahon is studying ways to grow kidneys from human stem cells. He says that the only way to determine whether he and his colleagues have successfully mimicked natural development is to compare their proto-organs to kidneys in fetal tissue. Although biomedical research is often done using mice as proxies for people, mouse kidneys are too different from human kidneys to use in McMahon’s work."

McMahon was the recipient of a $5.7 million CIRM award dealing with kidney problems. A CIRM document filed in connection with his now concluded research said,

"Our analysis of the developing human kidney has provided the first comprehensive insight into developmental processes highlighting molecular and cellular events shared with the well-studied mouse model, but unique human features."

McMahon was recruited from Harvard to USC with the help of the CIRM grant. In response to an email query, he said that it was unclear whether his CIRM research would have become ineligible for federal support, given new Trump review processes. 

Bradley Fikes and Gary Robbins of the San Diego Union-Tribune wrote, 

"The sensitivity of the (fetal tissue research) matter surfaced recently when UCSD drew unwanted attention after one of its employees mistakenly solicited fetal pancreas samples from the Center for Medical Progress (CMP), an anti-abortion group whose surreptitious videos in 2015 galvanized efforts to end federal funding of Planned Parenthood."

Trump Action on Fetal Tissue Research: Likely Impact on $5 Billion More for California Stem Cell Agency

President Trump today sharply cut back on federal funding for fetal tissue research in a move denounced as both politically motivated and destructive of the hopes of millions of Americans suffering from life-threatening diseases. 

The action has long been sought by anti-abortion activists who say tax dollars should not go to create a "marketplace for aborted baby parts."

Trump's moves immediately cost UC San Francisco a $2 million grant aimed at new therapies for HIV. It also drew reaction from California's $3 billion stem cell agency. 

Asked for a comment, Kevin McCormack, senior director of communications, said the Trump action will not have any impact on the agency. He said in an email, 

"Because our money comes from California this does not affect any project we fund or our ability to fund any projects."

Trump's action echoes a situation that played a major role in the ballot initiative campaign of 2004 that created the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). 

In one of their key arguments, backers of the stem cell measure said it was needed because of then President Bush's restrictions on federal funding for human embryonic stem cell research.

Today's action by Trump is virtually certain to be cited as justification for an additional $5 billion for the agency, which will run out of money for new awards around the end of this year. CIRM supporters expect to mount another ballot initiative in November 2020.

The scope of Trump's move was described by the New York Times, which wrote, 

"As of last year, the N.I.H. spent about $100 million of its $37 billion annual budget on research projects involving fetal tissue. The tissue is used to test drugs, develop vaccines and study cancer, AIDS, Parkinson’s disease, birth defects, blindness and other disorders. For much of that work, scientists say there is no substitute for fetal tissue."

Sam Hawgood, chancellor of UC San Francisco and a former member of CIRM's governing board, said in a statement that the decision was "politically motivated, shortsighted and not based on sound science.”

Lawrence O. Gostin, a professor specializing in public health law at Georgetown University, told the New York Times that the federal action "is akin to a ban on hope for millions of Americans suffering from life-threatening and debilitating diseases." 

Scientist Jeanne Loring, who is with Scripps Research and Aspen Neuroscience in the San Diego area, said in response to a query, 

"Fetal brain tissue transplants containing immature dopamine neurons laid the groundwork for the Parkinson’s disease neuron replacement therapy we are developing now  The outcomes were inconsistent, but some patients recovered from the disease.  Without that pioneering work in the 1990s, I wouldn’t be so confident about the potential of our planned therapy using dopamine neurons derived from Parkinson’s patients’ own induced pluripotent stem cells.

"This is one specific instance of how fetal tissue profoundly changed our view of degenerative disease.  I think that going forward, most of the regenerative therapies will be based on pluripotent stem cells, which weren’t available 30 years ago. But I don’t like to rule out the possibility that there is still pioneering work like this to be done, and so I hope that some researchers will not lose access to fetal tissue for groundbreaking medical research."

(Editor's note: Look for additional news tomorrow on the impact of the Trump decision in California and elsewhere on the California Stem Cell Report.)

Proven Value -- California's Stem Cell Agency Garners Praise in State's Largest Newspaper

California's $3 billion stem cell agency scored a significant media win this morning with an endorsement from one of its harshest critics, a Pulitzer Prize-winning columnist in the state's largest circulation newspaper, the Los Angeles Times.

Michael Hiltzik, who has written two books on massive public projects, wrote in the Times,

"California’s stem cell program has proved its value to the state and to science. It has earned the opportunity to show what it can achieve with an additional 10 years of life and billions more."

Hiltzik's piece appeared this morning in the print version of the newspaper, which says it has a readership of 2.1 million in the print version alone on Sundays. Hundreds of thousands more would be added online, where the column surfaced on Friday. 

Hiltzik began his column with some very bright news for the agency, known formally as the California Institute for Regenerative Medicine(CIRM). He said that Jonathan Thomas, chairman of the agency, told him that a CIRM-funded cure is headed for the marketplace. Hiltzik described it as "a major achievement."

He wrote,

"A stem cell-based cure developed by a team at UCLA for a rare disease — a 'bubble baby' disease that deprives children of a functioning immune system — is on a path toward expected approval by the Food and Drug Administration as early as next year. It would be the first treatment funded by the program to reach the market."

The achievement would come as the agency faces what Hiltzik called an "existential inflection point." CIRM expects to run out of cash for new awards later this year. The agency was created by voters in 2004 with $3 billion that the state borrowed.

The agency's existence depends on whether voters approve an additional $5 billion in additional bonds that would come from a yet-to-be-written ballot measure on the November 2020 ballot. Voters will need to be convinced that the agency has not frittered away its original $3 billion.

Hiltzik noted the agency's "ups and downs," including hype, conflicts of interest concerns and the affordability of stem cell therapies. He said a new ballot initiative offers an opportunity to make improvements in CIRM's operations.

Hiltzik wrote, 

"Klein told David Jensen of the California Stem Cell Report that he is contemplating a provision in the next initiative for “funding the infrastructure to work on access, to work with insurance companies, to work with Covered California, to work with Medicare, to make sure that there’s access, to make certain that public hospitals and public clinics in California get discounted prices.” That would be worthwhile, if it can be done."

Like most state agencies, CIRM labors invisibly. Its story and value proposition receive little public attention despite its attempts at ground-breaking science. Reporters are rarely seen at its meetings. Few articles are written about its affairs. 

That will change somewhat come the 2020 election season. However, media coverage will be dominated by national politics since it will be a presidential election year.  Given the scarce resources of the media nowadays -- along with other, expected, pressing California matters in the 2020 election -- stem cell research is unlikely to be on any front page (print or electronic) except infrequently, at best. 

Nonetheless, Hiltzik's column will be one of the key pieces that other journalists will dredge up electronically next year as they research ballot initiatives. And how the Times and Hiltzik have framed CIRM's work will be an important element in how other news stories are shaped. 

Faustian Bargains and Biotech Millions: A Fresh California Yarn

It is a California tale: The search for millions in cash to research and develop cures for terrible afflictions that destroy people's lives. 

But it is not centered in an office building in downtown Oakland, with great views of San Francisco Bay and overlooking Lake Merritt. 

The official plot summary goes like this:

"Desperate to secure funding for her med tech startup, an idealistic scientist and her husband strike an outrageous deal with a mysterious investor."

As Damian Garde wrote on STAT this morning, 

"There’s a new Netflix series involving biotech, venture capital, and Faustian bargaining. It's called 'What/If' and it’s about the founder of Emigen Molecular Sequencing who, despite her scientific acumen and noble goal of saving cancer patients, cannot seem to convince Silicon Valley’s ocean of vest-clad VCs to invest in her genomics company. ('I’m afraid Big Pharma would drown us in litigation,' says one, inexplicably.)

"That’s when she meets the all-powerful investor Anne Montgomery, played by Renée Zellweger, who seems to be splitting the difference between 'Basic Instinct' and 'Devil’s Advocate.' Montgomery offers her the money she needs to keep Emigen afloat, but the deal has dark implications for her earnest and unfortunately sideburned husband, who is a pro baseball player-turned-EMT with a night job as a bartender.

"Anyway, by the end of the pilot, there’s an embattled startup, a fractured marriage, and an unsolved assault. Your correspondent (Damian Garde) did not make it to episode two."

As for that Oakland enterprise mentioned earlier, it is the $3 billion California stem cell agency, which is running out of cash and looking for $5 billion more.  

Stem Cell 'Teething Problems' -- Pricing to Manufacturing, the European View

From Europe this morning comes a perspective on the "three obstacles" that are blocking cell therapy from the mainstream.

It is a subject, of course, that resonates in the United States and particularly in California, where the $3 billion state stem cell agency is running out of cash and needs a boost.

The article appeared on Labiotech, which bills itself as "leading digital media covering the European biotech industry." Written by Helen Albert, the piece actually lists more than a trio of "teething problems" for the stem cell industry. They are:

• "A reliable, consistent and scalable manufacturing system" 
• "Excessively high pricing"
• Safety, regulation and a knowledgeable workforce

Albert interviewed a number of industry executives in Europe. She also mentioned Orchard Therapeutics, which has a tie to California.  It has received an $8.5 million award from the state stem cell agency, formally known as the California Institute for Regenerative Medicine.

The United States is ahead of the game on regulation, according to the folks in Europe. Albert wrote, 

"The US regulators are currently in the lead when it comes to keeping up with the research and being open to changing their processes, according to (Alan O’Connell, partner at Irish life sciences VC Seroba). Although he says Europe is not too far behind. 'Certainly, the EMA (European Medicines Agency) is responding, but from my perspective, the FDA is taking the lead, at least currently.'"

The Albert piece said, 

"With the first CAR T-cell therapies (technically a combination of gene and cell therapy) to treat blood cancers gaining US and European approval last year and global investment of over €6.7B in cell therapy in 2018, the question on everyone’s lips is ‘is cell therapy about to hit the big time?’"

Labiotech's answer? "2019 certainly appears to be the start, if not the end, of cell therapy’s move to the big time."

No. 54: Counting California Stem Cell Agency's Clinical Trials, This One for Diabetes

The California stem cell agency has awarded $11 million to help treat type one diabetes, an affliction that affects 1.25 million persons nationally.

The award brings to $194.6 million the amount given to UC San Francisco (UCSF) since 2005 by the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. 

UCSF has held a seat on the governing board of the $3 billion agency since it was created by voters in 2004. About 90 percent of its funding has gone to institutions with ties to board members. They are not allowed to vote on awards involving their institutions, but the board can create or eliminate funding programs. 

The $11 million phase one clinical trial award last week went to Peter Stock of UCSF and was his first for a trial from the agency.  It is the 54th investment by the agency in a clinical trial. CIRM said in a news release:

"Transplantation of beta cells, contained in donor pancreatic islets, can reverse the symptoms of diabetes. However, due to a poor islet survival rate, transplants require islets from multiple donors. Furthermore, since islet cells are transplanted directly into the vessels that enter the liver, it is extremely difficult to monitor and retrieve these cells should the need arise.

"Dr. Stock’s clinical trial at UCSF aims to address these limitations. The trial will be using parathyroid glands to aid in the success and viability of the transplant procedure."

CIRM's review of Stock's application (CLIN2-11437) noted that questions had been raised about commercialization of his research. It said, 

"If efficacious, the proposed therapy could lead to US regulatory approval for islet transplantation and clear the commercialization path for this and future diabetes treatments in a field that needs innovation. Overall, the enthusiasm from clinical experts for the potential of a new approach outweighed commercialization concerns and the panel recommended the application for funding."

Looking Back and Forward at the California Stem Cell Agency: 1,000 Awards, $2.6 Billion, 1,200 Patients in Clinical Trials

A CIRM slide from tomorrow's presentation
on the stem cell agency's work.

The California stem cell agency has whomped up a fulsome presentation on its progress since it was created in 2004 and plans to unveil it at a public meeting tomorrow in Oakland. 

The presentation covers everything from cell therapy to de-risking stem cell investing for biotech companies. Maria Millan, CEO of the $3 billion enterprise, will run through the agency's 1,000 awards and 53 clinical trials during tomorrow's meeting of the governing board of the research effort. 

Her presentation comes at an increasingly critical time for the agency. It expects to run out of cash for new awards later this year. It is attempting to raise $220 million privately to help tide it over until November 2020, when it hopes to persuade California voters to give it another $5 billion. 

The agency, known formally as the California Institute for Regenerative Medicine (CIRM), is making the meeting available to the public through its usual Internet audiocast in addition to teleconference meeting sites in Riverside, La Jolla, South San Francisco, Fresno, San Diego, Palo Alto and two in Los Angeles.  That is in addition to the main meeting site in Oakland. (Full directions are on the meeting agenda.) The public can also ask questions via the Internet or the teleconference locations. 

Also up for tomorrow's meeting is discussion of possibilities of changes in CIRM's operations that might be embodied in a ballot initiative in 2020. Two governing board committees mulled over a wide range of options at a session last week, but no decisions were made. The measure is yet to be written but will need to be officially filed later this year. 

California Stem Cell Funding Flap: Stanford Ponies Up $1.8 Million

Stanford University has come through on matching funds for state-financed stem cell research, coughing up $1.8 million after California's stem cell agency applied a little financial pressure.

The matter involves Stanford  researcher Judith Shizuru, who is conducting a clinical trial that is aimed at treating the "bubble boy" genetic affliction without requiring high-risk chemotherapy or radiation. Her work has implications for reducing the need for the dangerous treatments in other diseases. 

In 2012, Shizuru was awarded $19 million by the stem cell agency for her trial. Late last year, she applied for $6 million more. 

Sharp questions arose, however, from the governing board of the $3 billion California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. It was the first time that the CIRM board had publicly rebuked a grantee and an institution on co-funding.

The board noted that the $19 million grant required $1.8 million in matching funds that had not been forthcoming.  

Directors pointed out that Stanford was well-endowed and should not be hard-pressed to provide cash to help develop a potentially "transformative" product that would eliminate the toxic impact of chemotherapy for a number of diseases. 

That was back in January. The CIRM directors set a May 1 deadline for seeing the cash. 

Last month the agency, which expects to run out of funds for new awards later this year, received a letter from Robert Harrington, the chairman of the Department of Medicine at Stanford. 

The letter said, 

"This letter is to confirm that the Department of Medicine will provide funding in the amount of $1,784,953 to meet the required co-funding for Operational Milestones #3 and #4 disbursements as referenced in your email dated 3/14/19 for the above referenced grant. These funds are available immediately to Dr. Shizuru for the study."

The flap also led to an inside look at how research funding works at the stem cell agency in a case involving a rare affliction, delays in clinical trials and the financial pressures now facing CIRM. 

Over its 14-year life, the agency has awarded $2.6 billion. Stanford is the No. 1 recipient with $383 million. Its total far exceeds the No. 2 recipient, UCLA, which has chalked up $284 million. 

Nine out of the top 10 recipient institutions, including Stanford and UCLA, have members on the CIRM governing board. They are not allowed to vote on awards to their institutions, but they establish the research award programs and their rules. 

Legislation to Regulate 'Snake Oil' Stem Cell Clinics in California Hits Fiscal Speed Bump

California legislation to crack down on "snake oil" stem cell clinics has stalled after a cost of $100,000 was assigned to the measure, which is backed by the state's stem cell research program. 

The bill was sent last week to a "suspense" file, which holds fiscal legislation while lawmakers juggle priorities in the Golden State's yet-to-be-approved, $213 billion budget.

If all goes well, the measure could clear the Assembly Appropriations Committee in the next month or so and be sent to the floor of the Assembly. It would then go to the Senate for more committee hearings and a Senate floor vote.

No public opposition has yet surfaced to the measure (AB617), authored by Assemblyman Kevin Mullen, D-San Mateo. It would not take effect any earlier than 2020.

The bill would require California's Medical Board to move on the clinics, which have proliferated across the country in recent years. California has more than 100, according to the latest estimates. 

The clinics charge thousands of dollars for treatments using substances that they describe as stem cells. However, in virtually all cases, the treatments have not been tested scientifically. Some have led to serious injuries. 

The state Medical board would be required to create a stem cell advisory group by February 2020 that would make recommendations by July 2020 for regulation of the dubious clinics.

The new group would have nine members. Three would be appointed by the California stem cell agency, three by state Medical Board, two by the state osteopathic medical board and one by the state nursing board. 

The group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice. 

Last week, a committee of directors of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known, endorsed the bill. The full board is expected to ratify that endorsement on Thursday. An analysis prepared by the legislative staff already lists CIRM as a supporter.