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: 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.)

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.

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. 

New Effort to Require California Medical Board to Act on Snake Oil Stem Cell Clinics

A California measure aimed at regulating "snake oil," stem cell clinics sometime next year has taken a major turn as it wends its way through the legislative process in Sacramento. 

The bill, AB617, was amended this week to 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.  An earlier version of  the measure placed responsibility with the state Department of Public Health. 

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. 

According to the latest version of the measure, 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 group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice. 

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 changes in the bill mean that it will require a 70 percent vote by both houses of the legislature. The previous version would have required only a majority vote. The increase is dictated by the fact that it changes Proposition 71 of 2004, which created the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

A spokesman for CIRM said today,

"CIRM is working with legislators to help them pass a bill that will regulate clinics offering unproven and unapproved stem cell therapies."

The California Stem Cell Report has asked Mullin's office for comment on the rationale for the latest amendments. We will carry his comments verbatim when they are received. 

(Following the posting of this item, Mullin released a statement that said: 

(“An important part of the legislative process is working with stakeholders to make sure legislation is as effective as it can be. Our amendments to move the requirements of AB 617 to the California Medical Board's jurisdiction will have a positive outcome. I look forward to continuing to work with MBC, CDPH, CIRM and others to address the serious issues related to potentially fraudulent stem cell clinics.")

The bill has cleared its first Assembly committee and is now before the Assembly Appropriations Committee. 

(An early version of this item said that a staff analysis of the bill said it was supported by CIRM. That phrasing was replaced in this version by the quote from CIRM.)

California's Intial Moves on Regulation of Dubious, Unregulated Stem Cell Clinics

Legislation targeting unregulated,"snake-oil," stem cell clinics easily cleared its first hurdle yesterday and was put on track for speedy approval by the  California legislature.

The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.

The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."

The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.

An analysis of the measure (AB617) by legislative staff said,

"According to the Centers for Disease Control and Prevention in the past year, at least 17 individuals across five states were hospitalized after being injected with therapeutic products made from umbilical cord blood. These particular illnesses have been identified as bacterial infections that have caused swollen spinal disc, infected bones and joints, and abscesses on their backs. Of the 17 infections, 15 have been linked to a single California based company that sells vials of a solution containing umbilical cord blood that they market to ‘stimulate regenerative healing.'" 

Mullin's  bill would charge the state Department of Public Health with creating a body by February 2020 that could enact "emergency" regulations, with 90-day  notice, to deal with clinics not in compliance with federal regulations. The panel would also be charged with making recommendations to the legislature by July of next year for new laws concerning the clinics.

The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.

Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.

Going Slow in California on Stem Cell "Snake Oil"

California Attorney General Xavier Becerra is remaining mum on regulation of "snake oil," stem cell clinics as the Golden State pursues a go-slow approach to cracking down on the dubious treatments.

More than 100 such clinics are operating in California, the most of any state in the nation. New York state earlier this month took the lead among states in attempting to regulate the clinics, which the chairman of California's $3 billion stem cell agency, Jonathan Thomas, has described as peddling "snake oil."

New York Attorney General Letitia James filed a lawsuit earlier

Letitia James
NY Department of Justice photo

this month charging that the treatments at one clinic amounted to fraud. She said in a news release,

“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral. 

“We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are unproven.”

The businesses number more than 700 nationwide and have treated an estimated 20,000 persons. The clinics sell products that they say are stem cells for use as treatments for problems ranging from erectile dysfunction to cancer. The treatments lack rigorous scientific testing and cost thousands of dollars. In some cases in Florida, they have resulted in blindness. Other serious injuries have been reported elsewhere.

In the wake of the New York action, the California Stem Cell Report, on April 5 and again on April 11, queried the California attorney general's office about his position on the dubious clinics. However, Becerra's office has failed to respond.

The web site of the state Department of Justice, which is headed by Becerra, says, however,

"The Department of Justice will put patients first in a more quality health care system. We achieve this by protecting patients from bad actors...."

Other California state entities have expressed concern about the unregulated clinics but also offer only a slow schedule for action, if any.

Six months ago, the state Medical Board, which regulates physicians, created a task force to look into problem. Asked recently about the task force's progress since October, Carlos Villatoro, spokesman for the board, responded briefly,

"The board is gathering information for the Stem Cell and Regenerative Therapy Task Force and has set a goal to have its first meeting in late May, early June."

In the legislature, Assemblyman Kevin Mullin, D-San Mateo, has introduced a measure to deal with the clinics. His bill, if it is passed and signed into law, would not take effect until next January. It would direct the state Department of Public Health to hold hearings sometime next next year in order to craft possible legislation to directly regulate the clinics. 

A new regulatory panel called the Stem Cell Clinic Regulation Advisory Group would be created. After members are named and organized, it would have the ability to enact "emergency" regulations on a 90-day notice after it has consulted with "the medical community, bioethicists, legal scholars, and patient advocacy groups."

The legislation (AB617) is scheduled to receive its first hearing in the Assembly Health Committee April 23.

The unregulated stem cell clinics have been in business for years. Their dubious treatments and sales pitches have been well documented. UC Davis stem cell scientist Paul Knoepfler has been particularly active. He and Leigh Turner of the University of Minnesota were the first to document the full scope of the clinics in a groundbreaking study in 2016.

In recent years, the Food and Drug Administration (FDA) has become more active. In the case of one California firm, Cell Surgical Network, which has been in business since 2010, the FDA sued the firm last May alleging that it had, among other things, used a smallpox vaccine to create an unapproved stem cell product. The product was injected directly into tumors in persons with potentially compromised immune systems, the FDA said.

Crackdown on Stem Cell Snake Oil: California's Approach vs. New York's

An attempt in the California legislature to take limited and preliminary action to regulate "snake oil" stem cell clinics stands in sharp contrast to this week's legal action by New York state's attorney general.

California's Assembly Health Committee has scheduled an April 23 hearing on the bill (AB617) by Assemblyman Kevin Mullin, D-San Mateo. Supported by the $3 billion state stem cell agency, it would require the state Department of Health to look into the dubious clinics next year and make recommendations to the legislature.

The legislative hearing comes as New York state attorney general Letitia James announced a lawsuit yesterday against a New York business that has performed what she said are unproven and rogue procedures on patients. 

The enterprise is called Park Avenue Stem Cell. A New York Times article by Reed Abelson said, 

"According to (New York) state regulators, Park Avenue Stem Cell also had ties to a California business, Cell Surgical Network, with roughly 100 affiliates around the country, that was sued by the F.D.A. (the Food and Drug Administration) last year. The federal agency is seeking a permanent injunction against Cell Surgical Network...."

California is taking a slower and more limited path than New York.  Mullin's legislation would do little to halt activity by the clinics this year. California's attorney general, Xavier Beccera, has not spoken out publicly on the issue. The state medical board has created a task force to look into the problem but it is unclear whether it has made any headway.

California has the largest number of the clinics, more than 100, according to a 2016 study and its authors. The New York Times said the businesses "offer people treatments that cost thousands of dollars, which patients typically pay out of pocket because health insurers refuse to cover the therapies. Some products have proved dangerous to patients, blinding some and causing severe infections in at least a dozen people."

UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota were the first in the nation in 2016 to document the full scope of what the chairman of the state stem cell agency, Jonathan Thomas, has dubbed a "snake oil" industry. 

Regarding the New York lawsuit, Knoepfler was quoted by the Washington Post as saying, 

"The unmistakable message is that the firms' time to come into compliance is rapidly running out."

California Legislation Targets Unregulated "Stem Cell" Clinics but Not Until Next Year

Legislation that may lead to regulation of dubious stem cell clinics is now before California lawmakers, but it is not likely to result in action until sometime next year at the earliest. 

Assemblyman Kevin Mullin, D-San Mateo, announced the measure (AB617) last week. He said in a news release, 

Kevin Mullin, LA Times photo

“It is clear that more must be done to ensure the proper regulation of for-profit stem cell clinics."

More than 100 unregulated "stem cell" clinics exist in California and hundreds more throughout the nation. They use what they describe as stem cells in untested treatments that cost thousands of dollars. A number of injuries, including blindness, have been reported. (See here, here, here and here.)

Jonathan Thomas, chairman of the $3 billion California stem cell agency, told its governing board last week that the clinics were peddling "snake oil."

Mullin's bill would create an advisory board within the state Department of Public Health to study the problems involving unregulated stem cell clinics and make recommendations to the legislature. 

The panel would also have the power to enact emergency regulations. If passed by the legislature this year, it would not take effect until next January. In addition to requiring hearings, the board could not implement emergency regulations without at least a 90-day waiting period.

Art Torres

Asked for comment on the legislation, Art Torres, vice chairman of the state stem cell agency and a former state lawmaker, told the California Stem Cell Report that he would withhold remarks on the bill until  "we work out final language/amendments before its first hearing in April."

Generally, proposed laws, including Mullin's measure, do not take effect until January of the following year after they are approved by both houses of the legislature and signed by the governor. 

Legislation that has "urgency" status can go into effect immediately, but such measures require a two-thirds vote of both houses instead of a simple majority. Securing a two-thirds vote can sometimes be difficult. 

The problems surrounding unregulated clinics have existed for years, but received little attention at the state or federal level until UC Davis researcher Paul Knoepfler and Leigh Turner of the University of Minnesota documented the scope of the business in 2016.

California's state medical board, which regulates physicians, is also looking into the unregulated clinics.

California Legislation to Curb Unregulated Stem Cell Clinics Due by March

Legislation to help stem the tide of unregulated stem cell clinics in California is still being drafted, but is inspected to be introduced by the end of this month. 

Art Torres, vice chairman of the California stem cell agency, is working on the measure, which is expected to be authored by Assemblyman Kevin Mullin, D-San Mateo. 

More than 100 dubious stem cell clinics are estimated to be in business in the Golden State, peddling ostensible stem cell treatments that cost thousands of dollars.  The treatments, however, have no scientific proof of efficacy or safety. 

In response to a question, Torres, a former state lawmaker, said that Mullin will introduce legislation that will serve as a placeholder while the legal language is worked out and coordinated with appropriate state agencies.

Torres said in an email, 

"We will have the language ready by March 1 , 2019, to be amended into the spot (placeholder) bill. 

"April 26 is the last day that a policy bill with fiscal implications must be out of the policy committee and referred to the fiscal committee."

The clinics and their treatments are a national issue as well involving the Food ad Drug Administration, which has been slow to move. California legislation is likely to serve as something of a model for other states.

The Odd Stem Cell Position of the Golden State: Hype, Hope and Dubious Clinics

The California stem cell agency and the Golden State's robust scientific stem cell community received some notice this week in the the Los Angeles Times, the state's largest circulation newspaper. 

It came in the form of an op-ed article that decried the booming business enjoyed by unregulated stem cell clinics, a field where California leads the nation. The Times says it has 1.4 million readers daily and 2.4 million on Sunday.

Usha Lee McFarling, a Pulitzer Prize-winning journalist and currently an artist in residence at the University of Washington, wrote the article discussing the issues surrounding the dubious clinics and their considerable risks, which do not seem to discourage those seeking help. She said,

"So why do patients keep streaming in for treatments that cost thousands of dollars? Part of the reason, I suspect, is that stem cell research — the serious, scientific kind — has gotten so much hype in recent years. We’ve all heard about how some stem cells have the power to become any type of cell in the body and might one day offer cures for all manner of crippling and degenerative diseases. If you can jump the line, and get those treatments now, why not do it? 

"Here’s why: Because the days of miraculous cures, if they come, are far in the future. Today, there is only one federally approved stem cell product: the limited use of blood-forming stem cells to treat certain blood disorders. Scientists are just beginning to learn how to harness the power of stem cells, and the harsh reality is that clinical trials that could turn that knowledge into effective therapies will take years, if not decades."

McFarling continued, 

"California is in an odd position. It is the state with the most stem cell clinics in the country offering these unproven 'cures.' It also happens to be a world center of serious scientific stem cell research, thanks to a $3-billion ballot initiative, Proposition 71, passed by voters in 2004 to fund research."

She noted the fledgling efforts at the state and national level to deal with the dubious clinics. McFarling wrote, 

"Here’s an idea in the meantime. The many scientists who have benefited from taxpayer support of stem cell research in the state should start speaking out. After all, the hype from proponents of Prop. 71 (which created the state stem cell agency) is part of what created such high expectations for quick cures – and eagerness on the part of patients to get them. Scientists should now take every opportunity both to explain to the public the long-term goals of their research and the absurdity of the so-called cures now flooding the market."

Our take: Her advice to California researchers is sound. However, it should be noted that a number of researchers, notably Paul Knoepfler at UC Davis, have been sounding warnings for years. The mainstream media, meanwhile, largely ignored the problem. It took two scientists to do the legwork, which could have been done by journalists as well, that has been the key building block behind the current regulatory efforts, which are still in their infancy.

Serious Infections and Fecal Contamination Alleged; Feds Battle Rising Tide of Dubious Stem Cell Clinics

The federal government last week stepped up its efforts to curb dubious stem cell clinics, declaring that 12 persons have been hospitalized for infections as the result of treatments involving a San Diego firm.

Some of the products from the firm have been found to have been contaminated with fecal bacteria . 

The federal action (see here and here) comes after years of ignoring the problem, both by the Food and Drug Administration and state regulators. Meanwhile, the growth of unregulated clinics as multiplied. Current estimates are that as many as 700 or more clinics exist in the United States, compared to at least 570 in 2016. 

California has the biggest share of the clinics, which is not unusual since it is the most populous state in the nation. Legislation backed by the California stem cell agency is expected to be introduced in California next month to step up regulation of dubious clinics.

The federal enforcement action came in the form of a "warning" letter from the FDA and involved a firm called Genetech (no relation to the well-respected biotech firm Genentech, but obviously a name designed to lure unsuspecting patients.)

The FDA said 12 patients have contracted serious infections as the result of injections involving Genetch procedures and products. The Center for Disease Control has reported that some of its unopened products contain E. coli and E. faecalis.

Genetech has not responded to multiple efforts by media to obtain a comment on the federal action.

Some stem cell scientists, most prominently UC Davis researcher Paul Knoepfler, have warned repeatedly for years about the unregulated treatments. In addition to the harm to patients, they have noted that the activities of the dubious clinics damage the reputation of the field in general. (See here, and here and here.

California Setting Stage for Crackdown on Dubious Stem Cell Clinics

The California stem cell agency, state regulators and lawmakers are taking aim at the more than 100 dubious, unregulated "stem cell" clinics now operating in the Golden State.

The goal is to curb clinics that are using what they describe as stem cells in treatments costing thousands of dollars but that have not been tested  scientifically. Lawsuits have been filed around the country alleging damage to patients that includes blindness.

Art Torres, vice chairman of the state stem cell agency, is now  working with lawmakers to formulate legislation that is expected to be introduced by the end of January.

At the same time, the State Medical Board, which licenses and regulates physicians, has chartered a task force to look into the the growing business.

Earlier this fall, Torres told the governing board of

Kevin Mullin, LA Times photo

the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, that he was engaged with Assemblyman Kevin Mullin, D-San Mateo, on a bill.

Torres, a former state lawmaker, said the legislation is expected to involve certification of clinics by a state department. He said, 

"It involves a number of issues which we (CIRM) really can't be involved with in terms of licensing, but we certainly can be involved with the parameters and the distinctions that we ought to raise as to what constitutes an appropriate stem cell clinic in California."

The Medical Board is scrutinizing the promotional practices and harm caused by the clinics with the intent of crafting regulations to curb abuses.  

The board's starting point is a report by the Federation of State Medical Boards, which says,

"There is reasonable concern about a growing number of providers and clinics in the United States that are undermining the field. Such providers and clinics have been known to apply, prescribe or recommend therapies inappropriately, over-promise without sufficient data to support claims, and exploit patients who are often in desperate circumstances and willing to try any proposed therapy as a last resort, even if there is excessive cost or scant evidence of efficacy."

Paul Knoepfler, a UC Davis stem cell scientist who has long been involved in examination of dubious clinics, has reported that at least 100 such clinics exist in California. 

Writing on his blog Nov. 30, Knoepfler said,

"Broadly, it may be going rapidly from the best of times to the worst of times for unproven stem cell clinics in the U.S., which would be a very good thing for patients and the stem cell field, if it actually happens. We’ll see."

Combating Stem Cell Snake Oil: A Primer From a California Researcher

Hundreds of dubious, unregulated stem cell clinics exist throughout the country with the most in California. Desperate people seeking help have been maltreated and fleeced. What to do?

UC Davis stem cell research Paul Knoepfler has produced a useful guide to reporting dubious
activities along with a list of state and federal agencies that could have a role.

In an item on his blog last week, Knoepfler wrote,

"I would emphasize concrete reasons for concern such as the use of an unapproved stem cell drug product by the clinic, a physician practicing outside their area of expertise so putting their patients at risk, false marketing, and potential or documented (if they’ve already happened) patient harms.

"For some clinics that aren’t led by physicians, I would also emphasize the risks of non-physicians such as chiropractors or Ph.D.s doing procedures for which they aren’t trained or licensed. I think patients (or people communicating on their behalf) making complaints about clinics and their personnel will have the greatest impact."

Knoepfler continued,

"We can make a difference by pushing back on the worst clinics. Of course, not every action by those of us in the stem cell arena who are concerned about predatory clinics will hit a bullseye to make real change, but sometimes it has happened in the past and will happen again in the future too."

I would add that the activities and stories that emerge from these dubious enterprises damage the reputation of the field as a whole. Indeed, when I talk to folks in the general public, the clinics' offerings are the most often mentioned reference they have.

As California's stem cell agency moves closer to seeking more billions from voters in 2020, fraudulent stem cell activity could create much confusion about the legitimacy of the entire field. Supporters might want to keep that in mind. But critics should as well. Fleecing the public with unproven therapies is unhealthy for those who are swindled but also for society in general.

The 'Renegade Outposts' of the Stem Cell Industry: A Sweeping Examination by the SF Chronicle

Chronicle graphic

"Merchants of hope" was the headline today on a lengthy look by the San Francisco Chronicle at what it called the flourishing but costly, unproven and largely unregulated stem cell clinics in the United States and California.

Written by Erin Allday, the piece said,

"They are renegade outposts operating with little legitimacy and oversight at the frontier of what is otherwise a highly promising field of medicine."

It was the second installment in the Chronicle's look at stem cell treatments, both dubious and not-so-dubious. The first was published last month.

Today's piece took a lengthier look at the dubious efforts than has been done in other recent,  mainstream media examinations of the field, which is drawing increasing scrutiny from federal regulators. Allday wrote,

"None of the treatments the clinics offer have been shown to be safe or effective. None have been approved by the FDA. They’re not backed by decades of laboratory and animal studies or by rigorous testing in humans.

"Yet for many patients desperate for care, these clinics fill the void between the long-anticipated potential and the real-world limitations of stem cells. They cater to people whose needs reach beyond the powers of current medicine — people who want to believe in the almost mythic powers of stem cells, who feel corporate health and science have forsaken them.

"People who turn instead to these merchants of hope."

The article also touched briefly on the $3 billion California stem cell agency. Allday said, 

"The California Institute for Regenerative Medicine (CIRM) — the state agency created by Proposition 71 in 2004 to fund stem cell research — has raised concerns about the thriving consumer therapy market. CIRM officials and many of the scientists they fund worry that the selling of unproven treatments could undermine their own work and cast doubt on the enormous potential of regenerative medicine."

Allday continued,

"'It really hurt our recruitment,' said Jane Lebkowski, president of research and development at Regenerative Patch Technologies in Portola Valley. 'We got a lot of questions: What happened in Florida? Am I going to go blind too?'

"Most patients, Lebkowski noted, don’t understand the difference between the fat stem cells that a for-profit clinic is using and the complex product her company is developing, which uses embryonic stem cells to develop a kind of retinal cell that’s damaged in macular degeneration.

"That’s part of the reason why scientists like Lebkowski and organizations like CIRM, which gave $17 million to the Regenerative Patch trial, have pressured the FDA to crack down on the consumer market."

The next installment in the series will deal with stem cell research and is scheduled for publication Aug. 16.

Expansive Media Series on California's Stem Cell Agency as It Nears Cash Cutoff

Lead photo on Chronicle stem cell series, photo by Gary Wathen

The San Francisco Chronicle today kicked off a major look at California's $3 billion stem cell agency with a multimedia presentation that covered everything from stem cells and how they work to the desperation and hope of patients with all-but-untreatable afflictions..

The four-part series will roll out over the next six weeks in the Chronicle, which says it reaches 1.7 million persons weekly in the San Francisco Bay Area via both print and electronic means. The series looks to be the most expansive look ever at the agency, which is formally known as the California Institute for Regenerative Medicine (CIRM).

The Chronicle effort, which has been many months in the making, comes as the agency is facing its lingering demise unless efforts to raise more billions are successful. CIRM expects to run out of cash for new awards by the end of next year. It is attempting to raise privately more than $200 million to bridge a financial gap with the hope that voters will approve a yet-to-be-written, $5 billion bond measure in November 2020.

The series is likely to have a significant foundational role in more news coverage of the agency as it nears its cash cutoff. As a starting point, reporters will be examining the Chronicle's work and other previous coverage of CIRM, which has all but vanished from news pages and news screens of California readers.

Patient Hopes and Unregulated Treatments

The initial installment in the Chronicle series, written by Erin Allday, had little specific to say about the agency, but dwelt on patients' hopes of finding unregulated stem cell therapies both within California and outside of the state. One piece served as a primer and was called "What Are Stem Cells and How Do They Work." The other two major pieces were headlined,

"In Search of a Miracle: She Tried Everything to Heal Her Son; Stem Cells Were Her Last Hope"

and

"Driven by Desperation: Out of Options, Six Patients Turn to Stem Cells."

An editor's note tied to the series said,

"'The Miracle Cell' explores the hope and reality of the revolutionary science of stem cell therapy. It focuses on what has transpired since 2004, when California voters approved a $3 billion bond measure to fund stem cell research with the promise that it soon would produce new treatments for incurable diseases.

"In four parts, it follows the stories of patients desperately seeking remedies; probes the for-profit clinics where unproven and unregulated treatments are being offered; takes you into the labs and hospital rooms where scientists are testing new therapies; and provides a comprehensive accounting of what California’s multibillion-dollar bet on stem cells has achieved."

The main piece today dealt with a nine-year-old boy from Scott's Valley, Ca., who received stem cell treatments in Tijuana. The story also documented the "powerful allure" of the therapies. Allday wrote,

"In 2004, California voters were so convinced that cures from stem cells were close at hand that they approved Proposition 71, a $3 billion bond measure to pay for research that the federal government would not.

"Nearly 15 years later, no proven therapy has emerged. But some doctors already claim to have tapped stem cells’ potential. And some patients refuse to wait any longer to seek treatment."

Asterias and Paralysis 

One of the six profiles of patients involved Mary Ambery, 59, who was paralyzed from the neck down in a fall in 2017. She is now engaged in a clinical trial run by Asterias Biotherapeutics, Inc., of Fremont, Ca.  The Chronicle reported, 

"Before the transplant, she had almost no movement in the muscles that allow her to bend her arms at the elbows and rotate her wrists. She couldn’t pinch her thumb and forefinger together. She couldn’t feed herself or comb her hair, couldn’t use a smartphone or a pen.

"More than a year after the surgery, she can do her own makeup and hair. She can use a fork, but needs help cutting up her food. She can text with her friends, she can write 'pretty legibly.'"

The story did not mention that Asterias' work has been supported by $21 million from the California stem cell agency.  

The next installments in the series are likely to contain more details on the Golden State's stem cell program. Here are the one-word topics and expected dates of publication: Clinics, July 25; Research, Aug. 8, and Progress, Aug. 22.