Rogue Stem Cell Clinics and Covid: California Moves 'Sedately' on Regulation

The state of California and its top medical regulator remain mired in a go-slow posture on regulation of "snake oil" stem cell clinics that are currently riding the Covid crisis to peddle dubious treatments to desperate patients.

The marketing surge by the clinics has drawn increased attention nationally, including in prestigious scientific journals such as Cell Stem Cell whose usual fare deals with such things as "Stem Cell Hierarchy in Colorectal Cancer."

But one article published earlier this month was titled:

 "Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed 'Stem Cell Treatments' for COVID-19." 

The quotes around "stem cell treatments" are deliberate. No guarantee exists that the treatments actually include stem cells. 

Leigh Turner, an associate professor of bioethics at the University of Minnesota, authored the piece. He said,

"In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for Covid-19. 

"Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for Covid-19."

Nearly two years ago, California's State Medical Board said it was going to tackle the problem of the rogue clinics. But to this date little has occurred. State legislation to develop regulations was also sidelined.

The California Stem Cell Report queried the medical board earlier this month concerning the status of its effort and whether regulations had been drafted and when a draft would be ready. In response, the board last week released the following statement:

"The board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow that will include a sample informed consent document and educational materials for the public to present to the board for review and final approval. 

"In the meantime, pursuant to Business and Professions Code section 684, healthcare practitioners providing stem cell therapy not approved by the Food and Drug Administration (FDA) and who have not obtained approval or clearance for an investigational new drug or device exemption from the FDA for the use of human cells, tissues, or cellular or tissue-based products, must provide notice to their patients indicating the lack of FDA approval, and encouraging their patients to consult with their primary care physician before treatment. Individuals concerned about a physician’s stem cell practice should file a complaint with the Board for review and appropriate action."

The issues with the clinics has drawn attention in the Los Angeles Times from Pulitzer Prize winning columnist Michael Hiltzik  who wrote recently,

"The proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The Covid-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims."

The California stem cell agency has also pushed for tighter regulation and partnered to help pass the law for disclosure notices concerning lack of FDA approval. For patients considering stem cell treatments, the agency has posted as rundown on issues concerning the treatments or clinical trials. 

(After this item was posted, the agency posted a blog item dealing with Parkinson's. In addition to information on the search for a cure or treatment, the item carried the following advice for persons seeking some sort of unregulated treatment. Here is what the agency had to say in a Q&A format,

"If you go online you can find lots of stem cells clinics, all over the US, that claim they can use stem cells to help people with Parkinson’s. Should I go to them?

("In a word, no! These clinics offer a wide variety of therapies using different kinds of cells or tissues (including the patient’s own blood or fat cells) but they have one thing in common; none of these therapies have been tested in a clinical trial to show they are even safe, let alone effective. These clinics also charge thousands, sometimes tens of thousands of dollars these therapies, and because it’s not covered by insurance this all comes out of the patient’s pocket.

("These predatory clinics are peddling hope, but are unable to back it up with any proof it will work. They frequently have slick, well-designed websites, and  'testimonials' from satisfied customers. But if they really had a treatment for Parkinson’s they wouldn’t be running clinics out of shopping malls, they’d be operating huge medical centers because the worldwide need for an effective therapy is so great.

("Here’s a link to the page on our website that can help you decide if a clinical trial or “therapy” is right for you.")

State Medical Regulators To Take Up Dubious Stem Cell Clinics in November: Adverse Events, More Education on Table

The next step in possible California state regulation of rogue stem cell clinics will come Nov. 7 at a meeting of the state's medical board. 

The news follows a meeting last week by a two-person task force of the medical board to deal with the growing use of unproven treatments. (See here and here.)

The California stem cell agency reported on its blog, in a piece by Yimy Villa, about possibilities the board is considering:

• "Guidance and education materials for medical practitioners
• "Sample informed consent documents designed to inform patients about the potential risks and benefits of stem cell treatments
• "Public education materials
• "An adverse event reporting system"

In response to a query by the California Stem Cell Report, Carlos Villatoro, a spokesman for the board, said it would hear an update at its meeting in November in San Diego.
He released a statement that said.

"The board’s Stem Cell and Regenerative Therapy Task Force will continue to work on this issue with the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow. The task force would meet again to obtain input on any recommendations and/or guidelines."

The California stem cell agency has taken a "Three Rs" position on the rogue clinics: "Regulated, Reputable and Reliable."

No public meeting of the task force is scheduled at this time. Interested parties can send comments and suggestions to April.Alameda@mbc.ca.gov.

$1 Million StemGenex Bankruptcy: Only $300 in the Bank

The tale of a La Jolla firm called StemGenex appears to be winding down with a bankruptcy filing that says it owes more than $1 million and has assets of less than $156,000.

The current state of the "stem cell" enterprise, which is facing a patient lawsuit and federal scrutiny, was disclosed this week in the Los Angeles Times and on the blog of UC Davis stem cell researcher Paul Knoepfler. 

Knoepfler has followed the firm for years. In his posting Wednesday, he said the company's bankruptcy filing shows that it owes money to its landlord, some former employees, some of its attorneys and has only $300 in the bank. 

Yesterday, Michael Hiltzik of the Los Angeles Times, who also has followed the company for some time, wrote, 

"The filing opens a window into the scale of StemGenex’s business. It discloses revenues of more than $8.2 million dating back to Jan. 2, 2017. Based on the firm’s standard fee of about $14,900 per treatment, suggesting it may have had as many as 550 customers over that period; some have said they had more than one treatment, for which they were charged separate fees."

Hiltzik said that company officials could not be reached for comment and that the firm's attorney did not respond to a query. The company's web site no longer shows a phone number and identifies the firm as only an "educational stem cell resource."

Hiltzik reported that the lead attorney in the patient class action lawsuit says he will continue to press the company, including physicians formerly associated with it. 

A task force of California's state Medical Board next Wednesday is scheduled to begin hearings in Sacramento on possible regulations dealing with operations of dubious stem cell clinics and physicians associated with them.   

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

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

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

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

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

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

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

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

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

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

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

Deepak Srivastava
Gladstone photo

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

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

The headline on his article said, 

"Don’t Believe Everything You Hear about Stem Cells

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

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

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

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

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

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

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

Unregulated Stem Cell Treatments Targeted by California Medical Board; Hearing Next Week

"Snake oil" stem cell clinics in California and their physician operators are on the agenda next week of state medical regulators as deep concerns are being raised in Congress about the slow pace of federal action against the enterprises. 

Last week, a bipartisan group of leaders of a U.S. House of Representatives committee told the Food and Drug Administration (FDA) in a letter, 

"We appreciate the actions taken by FDA, but this pattern of unsafe and unproven therapies remains deeply concerning. Such treatments not only pose public health risks for patients, but also harm the future promise held by the development of stem cell therapy as a field."

California also has been slow in dealing with the issue. State legislation to deal with the matter has been shunted aside.  More than a year ago, the state's Medical Board created a task force to deal with the issue. The panel did not hold its first meeting until June 27 of this year and then with no public notice. 

Experts who follow growth of the dubious clinics say more than 1,000 exist in the United States. The largest number are in California. The treatments are unproven and cost desperate patients thousands of dollars. The clinics have been linked with several cases of blindness and at least 12 serious infections. The FDA has filed lawsuits against two, including one in California, and sent 45 letters to clinics involving their practices. 

The agenda for next week's state medical board meeting says only that an "update" will be delivered by the task force which consists of two members of the board, Randy Hawkins and  and Howard Krauss. No action was specifically listed for the agenda item (No. 21), but the board couches its agenda in such fashion that it could legally act on any matter before it. 

The Congressional letter to the FDA not only expressed serious concern about the proliferation of unproven therapies,  but also said, 

"The advertising strategies some of these clinics employ to attract some of the most vulnerable patients are particularly alarming. Some have advertised stem cell treatments to desperate patients with the most serious untreated illnesses, such as spinal injuries, Parkinson's disease, and multiple sclerosis. Some clinics have misled patients into believing that the therapies they offer are FDA approved or that they are being offered as part of an FDA sanctioned clinical trial."

The chairman of the board of California's $3 billion stem cell agency, Jonathan Thomas, has called the treatments "snake oil." The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is running out of cash. It is worried that a move to refinance the agency via a ballot measure next year could be harmed by voter confusion about the stem cell research.

The congressional letter said,

"When providers offer harmful, unproven stem cell therapies outside of the clinical setting, they create confusion among patients and undermine public confidence in treatments that have been proven to be safe and effective through well-designed clinical trials. If we are to realize the potential clinical benefits of stem cell therapies, it is crucial that developers focus their efforts on the use of traditional developmental pathways that yield definitive results rather than promoting products with 'dubious clinical efficacy and possible risks.'"

Next week's meeting is open to the public. Letters to the board can be emailed to executive director, Kimberly Kirchmeyer, at Kimberly.Kirchmeyer@mbc.ca.gov.