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."

"Natural Killer" Cells Score Points for $10.6 Million California Stem Cell Investment

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The Quest for Stem Cell 'Franchise Players:' California's $47 Million Recruitment Program

 Robert Weschler-Reya briefly discusses some of the implications of his research.

Nine years ago this month, the California stem cell agency kicked off a $47 million recruiting effort to lure star stem cell scientists to the Golden State in what was then an even more fledgling field than it is today.

The first recipient was Robert Weschler-Reya, who left Duke University to join the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Ca. Weschler-Reya surfaced again last week in an item on the stem cell agency's blog, The Stem Cellar, which discussed the research that he hopes will help children with a deadly brain cancer.

Back in April 2010, directors of the state's $3 billion stem cell agency awarded nearly $6 million to Weschler-Reya. But it took him months to make the decision to come to California. (For more on the process see here and here.)

Ultimately, the agency helped to bring eight other scientists to California through the recruitment effort. All of the awards in the program benefited institutions with past or present representation on the agency's governing board. Those directors could not vote on specific grants to their institutions, but they all voted in favor of creating the recruitment effort.

The overall approach was approved in 2009 by directors of the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Backers said it would lure "paradigm-shifting," "franchise players" to the state.

CIRM Director William Brody, then head of the Salk Institute in La Jolla but also a former president of John Hopkins University in Maryland, said that when California voters created the stem cell agency in 2004,

"I was sitting in Baltimore (and) the big concern was that there would be this big sucking sound for the senior people. And that, by and large, I don't think has happened because there's not been an appropriate mechanism to bring them, and I think this would do that."

As for Weschler-Reya, CIRM quoted him on its blog last week as saying that his research has developed "a valuable tool that will increase our understanding of the biology of the cancer and allow us to identify and test novel approaches to therapy. This advance brings us one step closer to a future where every child survives—and thrives—after diagnosis with CPC (choroid plexus carcinoma).

In his year-seven report on his CIRM research, Weschler-Reya said,

"The goal of our studies has been to elucidate the role of stem cells in development, regeneration and tumorigenesis in the cerebellum. We have made significant progress towards this goal during the course of our work.

"Our studies have provided insight into the types of cells derived from cerebellar stem cells during development, and shown that cerebellar stem cells can serve as cells of origin for pediatric brain tumors. Moreover, we developed several new stem cell-based animal models of pediatric brain tumors, and used them to study mechanisms driving tumorigenesis and metastasis. Importantly, we also used these models to screen for compounds that might be effective inhibitors of tumor growth, and identified a number of promising candidates. 

"Our long-term goal is to move these agents toward clinical trials, to improve outcomes for pediatric brain tumor patients."

Here is a list of all the recipients in CIRM's recruitment program. 

Institution	Researcher name	Grant Title	Award Value
University of California, Berkeley	Xavier Darzacq	Single Molecule Biophysics and Biology of Cellular Identity	$4,247,155
Gladstone Institutes, J. David	Todd McDevitt	Engineering microscale tissue constructs from human pluripotent stem cells	$5,884,058
University of California, Los Angeles	John Chute	Niche-Focused Research: Discovery & Development of Hematopoietic Regenerative Factors	$5,174,715
Cedars-Sinai Medical Center	Barry Stripp	Epithelial progenitors and the stromal niche as therapeutic targets in lung disease	$4,841,830
Stanford University	Hiromitsu Nakauchi	Generation of functional cells and organs from iPSCs	$5,427,512
University of California, San Diego	Eric Ahrens	Molecular Imaging for Stem Cell Science and Clinical Application	$5,920,899
University of Southern California	Andrew McMahon	Repair and regeneration of the nephron	$5,672,206
University of California, Santa Barbara	Peter Coffey	Development of Cellular Therapies for Retinal Disease	$4,690,963
Sanford-Burnham Medical Research Institute	Robert Wechsler-Reya	The role of neural stem cells in cerebellar development, regeneration and tumorigenesis	$5,226,049
			47085387

Backed by California Stem Cell Agency: $5 Million Measure for Spinal Cord Research Advances in Sacramento

Legislation supported by stem cell research advocates to provide $5 million for work on spinal cord injuries easily cleared its first hurdle this week in Sacramento.

On a 15-0 vote, the proposal, AB 214, was approved Tuesday by the Assembly Health Committee and sent to the Appropriations Committee for placement on the "consent calendar."  Such a move could speed action on the bill.

Assemblyman Kevin Mullin, D-San Mateo, authored the bill, which is backed by Americans for Cures, the Palo Alto stem cell advocacy group created by Bob Klein, the first chairman of the $3 billion California stem cell agency.

The agency, known formally as the California Institute for Regenerative Medicine (CIRM), is also listed as a supporter of the legislation. Other supporters included Aivita Biomedical of Irvine, Ca, the California Life Sciences Association and the Miami Project to Cure Paralysis.

The CEO of Aivita is Hans Keirstead, a stem cell researcher formerly with UC Irvine.

No opposition was listed in the legislative staff analysis of the bill.

The measure provides $5 million to support the Roman Reed Act of 1999, named after a man who was paralyzed as the result of a spinal cord injury. Roman and his father, Don Reed, are long-time backers of the stem cell agency's work.  The elder Reed is a vice president of Americans for Cures.

The legislative analysis carried this comment sourced to the bill's author:

"The previous allocations of approximately $15 million in state funding to the Roman Reed program was leveraged over five times that amount in new grants benefiting spinal cord research all across the state. It’s time to reinstate a modest amount of state funding so these efforts can continue."

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.