'Snake Oil' Stem Cell Clinics Target of California State Regulators Sept. 18

The California State Medical Board said today it will hold a public hearing Sept. 18 to respond to the burgeoning growth in dubious "stem cell" clinics, some of which have reportedly left some patients harmed both physically and financially.

"Snake oil" is what the unregulated clinics are selling, according to Jonathan Thomas, chairman of $3 billion California stem cell agency, which will be invited to appear at the Sacramento meeting next month. 

The clinics have been operating for years nationally, with at least an estimated 1,000 currently in business. California has the largest number. In the past couple of years, the clinics have achieved more notoriety. That includes a "buyer beware" piece this month on HealthDay.

Responding to an inquiry last week by the California Stem Cell Report, Kimberly Kirchmeyer, executive director of the Medical Board, said today in an email that topics likely to be covered at the board's hearing include:

• Best practices guidelines and outreach and education
• Improved informed consent practices
• Adverse event reporting when treatments go wrong
• Other options to be considered by the board

In addition to the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), the board said it would invite the state Department of Public Health. Members of the public may appear as well.  The Medical Board is the chief regulatory agency for physicians.

Here is the full text of Kirchmeyer's statement, which includes a timeline on the board's actions related to the dubious clinics:

"At the July 2018 Board Meeting, the Board was provided a policy that was adopted by the Federation of State Medical Boards at their annual meeting.  The policy contained several recommendations for state boards regarding Regenerative and Stem Cell Therapy Practices.

At the October 2018 Board Meeting Ms. (Denise) Pines, (president of the board), established a Board Task Force on Stem Cell and Regenerative Therapy.   In April 2019, Board staff met with the California Department of Public Health to discuss issues regarding stem cell and regenerative therapy and discussed how the two entities could work together.  The two organizations also discussed some of the issues regarding investigating complaints regarding these practices. 

"On June 27, 2019, the Task Force members met with Board staff to discuss oversight options the Board may decide to pursue to protect California consumers from unapproved and potentially dangerous stem cell products and therapies and next steps.  

"A few options discussed included the development of educational materials, exploring outreach opportunities, and developing best practice guidelines similar to those adopted by the Federation.  The Task Force also discussed the need for some type of guidance for informed consent.  While current law requires notice to patients regarding stem cell therapies, it only requires notification to the patient that the therapy is not FDA-approved and encouraging the patient to consult with their primary care physician. 

"The Task Force believes a more in-depth informed consent may be needed.  In addition, discussion also included the need for adverse event reporting and what would be required for such reporting. 

"It was determined that the Task Force hold an interested parties meeting to receive feedback from consumers, experts, and stakeholders to assist in the development of materials, guidelines and/or to determine if there are additional options that should be considered.  At this meeting, the Board is also going to ask for presentations from the California Department of Public Health and the California Institute for Regenerative Medicine.

"The meeting will be held September 18 in the afternoon (at board headquarters in Sacramento).  If necessary, a second interested parties meeting will be held by mid-November.  The Task Force hopes to have recommendations presented to the Board at its January 2020 meeting.  "You will be able to watch the update on the webcast when it is posted on the Board’s website within the next two weeks.  Here is the link to the page where the webcast will be posted: http://www.mbc.ca.gov/About_Us/Meetings/ "

California Stem Cell Agency's Business Partnering Program and BlueRock Therapeutics

A $240-million deal yesterday involved an East Coast biotech firm that has loose ties to California's nearly 15-year-old stem cell research program. 

The firm is Blue Rock Therapeutics, Inc., a privately held cell therapy company based in Cambridge, Mass.  Bayer owned about 60 percent of the company and picked up the remainder for $240 million in what it called a "major milestone." 

Last year, BlueRock was one of two companies that joined a program of the $3 billion stem cell agency to create a "built-in concierge service for the stem cell space." The agency, formally known as the California Institute for Regenerative Medicine (CIRM), called its new effort the Industry Alliance Program (IAP).

The agency said at the time, 

"The CIRM IAP is designed to give pharma, biotech and VC firms direct access to CIRM’s growing stem cell portfolio. These partners work in the stem cell and regenerative medicine field and will be connected to CIRM-funded scientists working on projects relevant to their interests."

Regarding the deal yesterday, Ben Fidler of Xconomy wrote,

"The deal gives Bayer rights to a company using cells harvested from healthy donors to develop cell therapies for a variety of different diseases—from neurodegenerative disorders like Parkinson’s to heart failure to graft versus host disease. But the buyout is a gamble on an ambitious technology whose first human study, in Parkinson’s, will start later this year."

So far, CIRM has not announced any fresh results from its industry alliance program. 

The California Stem Cell Agency: 'Envy of the World, ' Hopes Too High?

The prestigious journal Nature yesterday published a piece about California's $3 billion stem cell agency that spoke of voids, envy and "double-edged swords."

The opinion piece was written by Jeanne Loring, a San Diego area

Jeanne Loring

researcher who has followed the agency for years and has been one of its beneficiaries($17 million in awards).

Reflecting on the agency's importance, she wrote,

"For the past dozen or so years, stem-cell researchers in California have been the envy of the world."

Creation of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), "essentially guaranteed that the state would become the center of innovation in the field," Loring declared. Its demise would leave a major void, she said.

Loring continued,

"Although its intentions were laudable, CIRM raised the hopes of the public too high. It needed catchy advertising to gain voters’ support. One of its campaign slogans was 'Save lives with stem cells.' Effective advertisements often focus on a promise and downplay shortcomings, such as the time and resources required to advance a stem-cell therapy through clinical trials to market approval. No CIRM-supported therapy has been approved by the US Food and Drug Administration (FDA), resulting in dashed expectations.... 

"Still, fulfilment of the campaign promise is under way. CIRM has granted funding for 56 stem-cell-based clinical trials."

At the same time, dubious and unregulated clinics that peddle stem cell "snake oil" have proliferated across the country, leading the FDA to attempt a belated takedown of some of the enterprises.

The growth of those clinics is part of "the double-edged sword that is CIRM’s legacy,"  Loring said.

"The agency has enabled fundamental science and helped to establish know-how for rigorous assessment of stem-cell therapies. Earlier this year, my colleagues and I started a biotechnology company, Aspen Neuroscience in La Jolla, California, and are raising funds for a clinical trial of a neuron-replacement therapy for Parkinson’s disease. Without the work that CIRM has done to educate investors and researchers, this would have been very difficult. 

"But the agency’s work has inadvertently helped to boost unregulated, for-profit ‘clinics’ claiming, without sound evidence, that cells derived from fat, bone marrow, placenta and other tissues can cure any disease."

Loring said,

"CIRM has regularly denounced these clinics, which existed before the institute’s creation and will persist as long as they can make money. Still, it is easy to understand how public enthusiasm would spill over to those offering quackery."

Loring noted that the agency, which expects to run out of cash for new awards this year, is hoping that voters will give provide $5 billion more via a ballot initiative in November 2020. 

Loring urged rhetorical caution in the ballot campaign.

"We must strike a balance between future potential and current reality when we talk to the public. Researchers should emphasize that even when therapies show promise in mice, they often fail to work in humans. The only way to find out — and to check for safety — is rigorous scientific testing in clinical trials."

"We need to temper public hope," Loring wrote, while regulators, including the FDA and the California State Medical Board, bring the bad actors under control. 

California Stem Cell Agency Backs Breast/Ovarian Cancer, Brain Injury Research and More with $29 Million; $71 Million Left

Saul Priceman of the City of Hope. Priceman received $9.3 million last month from CIRM for a clinical trial for breast cancer. City of Hope video.

The California stem cell agency last month handed out $29 million to finance efforts to develop treatments for traumatic brain injury, ovarian cancer and more, leaving it with about $71 million for new research awards before its cash runs out. 

The nearly 15-year-old agency, known formally as the California Institute for Regenerative Medicine (CIRM), is hoping that a yet-to-be written ballot initiative for the November 2020 ballot will give it a $5.5 billion infusion. The agency began its life in 2004 with $3 billion. 

Fresh figures from the agency show that it has about $43 million available for new awards, not including those involved in a sickle cell anemia effort with the National Institutes of Health.  CIRM's contribution to that program totals about $28 million. The agency is still accepting applications in that program. 

The amount of funds available overall to CIRM could rise as funds come back to the agency as the result of termination of unsuccessful research.

In last month's two-hour meeting, CIRM's board approved five grant applications, but not without more public discussion than has occurred in some past years when the agency was flush with cash. 

Directors talked about priorities, CIRM's portfolio and the vagaries of the scoring process, which is done behind closed doors by out-of-state researchers/reviewers who do not have to publicly disclose their professional or financial conflicts of interest. 

But the meeting also led to a reflection by CIRM board member Jeff Sheehy on the value that CIRM has brought to the field and California. Sheehy is a patient advocate of the 29-member panel. He has been on the board since its first meeting in December 2004 and leads the board's public discussion during ratification of funding decisions by reviewers.

Sheehy told his fellow board members that he had lost his mother to ovarian cancer and knew the "incredibly painful, difficult road" that she walked.  He said that CIRM is providing a new path to a better future for cancer patients and others with dreadful diseases and urged diligence in supporting renewed funding for the agency.  

In formal action, the board approved a $9.3 million investment in a clinical trial for a treatment of breast cancer, the second most common cancer in women. The trial is the 56th in which the agency is involved. The award went to Saul Priceman of the City of Hope. The review summary of his application (CLIN2-11574) can be found here. 

The CIRM panel also approved awards to the following researchers and institutions. The review summaries for all, including applications not approved, can be found here. 

Mark Tuszynski, $6.2 million, UC San Diego, spinal cord injury (no UCSD news release)
Evan Snyder, $4.9 million, Sanford Burnham, ischemic brain injury (no Sanford news release)
Brian Cummings, $4.8 million, UC Irvine, traumatic brain injury (UCI news release)
Mark Humayun, $3.7 million, USC, age-related macular degeneration (no USC news release)

The CIRM news release on the July meeting and awards can be found here. The transcript of the meeting can be found here. 

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Embedding the Power of Stem Cell Therapies: California's Efforts and the Quest for $5 billion More

Everett Schmitt, photo by Meg Kumin

California's $3 billion stem cell agency has financed a lot of research that winds up as dense, inaccessible articles -- at least to the general public -- in costly scientific journals with imposing pay walls.

Sometimes, however, stories of hope and stem cell progress do emerge that are likely to resonate with the state's citizens. They are the folks who voted to create and finance the agency in 2004 and who are expected to be asked again for more billions next year.

One such example involves the cases of Evangelina Padilla-Vaccaro of Corona, Ca., Ronnie Kashyap of Folsom, Ca. From birth they suffered from what is known as the "bubble boy" disease.

Both children were born with severe combined immune deficiency (SCID) that is ordinarily fatal. But as the result of clinical trials that were backed with millions from the stem cell agency, both are still alive today. (See here and here.)

The agency is formally known as the California Institute for Regenerative Medicine (CIRM). It has a blog called The Stem Cellar. Today it published an evocative piece written by the mother of another child with the "bubble boy" affliction. 

In her case, the work that has saved her son's life was not financed by CIRM. But the agency carried her story as a powerful affirmation of the importance of stem cell research, wherever and however it is supported. 

Kevin McCormack, director of communications for the agency, wrote, 

"CIRM's mission is very simple: to accelerate stem cell treatments to patients with unmet medical needs. Anne Klein's son, Everett, was a poster boy for that statement. Born with a fatal immune disorder Everett faced a bleak future. But Anne and husband Brian were not about to give up. The following story is one Anne wrote for Parents magazine. It's testament to the power of stem cells to save lives, but even more importantly to the power of love and the determination of a family to save their son."

Anne Klein's article is just what supporters hope will be embedded in the hearts of voters come November 2020 when the next round of financing for CIRM will be on the ballot. 

These sorts of stories, however, have received little attention in the mainstream media, whose reporting resources are ever-diminishing. The media are hard-pressed financially and otherwise nowadays as their once highly profitable business models have been hard hit by the impact of the Internet. 

Nonetheless the agency is assiduously pumping out information and stories on what it calls its value proposition. Here is the final line in the item that CIRM published today:

"You can read about the clinical trials we are funding for SCID here, here, here and here."

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.

The "Hard Case" of Stem Cell Sound Bites and a Campaign to Raise Billions

The journal Nature today reported on the $5.5 billion plan to save what it called the "struggling" California stem cell agency, which is fast running out of cash for new research awards. 

In an article by Jonathan Lambert, Nature caught up with news that it is not so new to readers of this web site. 

The piece carried information from Robert Klein, who expects to lead a new ballot initiative effort late next year to provide the billions more for the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. 

Nature also had this from a man who served on the Institute of Medicine team that evaluated the California program in 2012.

Aaron Levine, Georgia Tech photo

"Aaron Levine, a science-policy researcher at the Georgia Institute of Technology in Atlanta, says that CIRM has put California at the center of stem-cell research worldwide. 'CIRM has been really important in driving stem-cell research forward, especially in the preclinical and proof-of-concept space,' he says. 

"But he isn’t sure whether that will convince voters to keep supporting the agency." 

The Nature article continued,

"'It will be interesting to see if the campaign is one of promised cures, or something a bit more nuanced,' says Levine. 'It takes time for a whole new field of research to result in cures, but that’s a hard case to make to voters in short sound bites.'"

Nature said Klein told it that he will form a non-profit lobbying arm in October or November to help support the campaign next year. 

The journal also said changes in the stem cell research program were anticipated in the new ballot initiative.  

"These include creating a dedicated staff of 10–15 people who would work with insurance companies and patients to improve access to clinical trials and future therapies."

UC Researcher on Stem Cells and California's Stem Cell Agency

The California stem cell agency recently highlighted a brief look at the field with a Q&A that ranged from the impact of the agency itself to dealing with questions about "miraculous" stem cell "cures."

The item appeared on the agency's blog and originated at UC Davis, which is among the top five recipients of funds from the agency, known formally as the California Institute for Regenerative Medicine (CIRM).

The school has received $143 million, making it fifth on the list of recipients in terms of dollars.

The Q&A involved Jan Nolta, head of the stem cell program at UC Davis. Some excerpts from what Nolta had to say:

Jan Nolta, UC Davis photo

"Perhaps the most promising and exciting research right now comes from combining blood-forming stem cells with gene therapy. 

"Along with treating the famous bubble baby disease, where I had started my career, this approach looks very promising for sickle cell anemia. We’re hoping to use it to treat several different inherited metabolic diseases.... 

"The beauty of this therapy is that it can work for the lifetime of a patient. All of the blood cells circulating in a person’s system would be repaired. It’s the number one stem cell cure happening right now. Plus, it’s a therapy that won’t be rejected. These are a patient’s own stem cells. It is just one type of stem cell, and the first that’s being commercialized to change cells throughout the body."

About the five Alpha stem cell clinics initiated by CIRM, Nolta said,

"These are clinics where the patients can go for high-quality clinical stem cell trials approved by the FDA [U.S. Food and Drug Administration]. They don’t need to go to 'unapproved clinics'a and spend a lot of money. And they actually shouldn’t."

California Medical Regulators Take Up Dubious Stem Cell Clinics Next Month

The California State Medical Board next month will discuss clinics that offer unregulated "stem cell" treatments that have allegedly led to blindness and tumors in some cases. 

The meeting comes a year after the board created a "task force" to address the issue.  It also comes as more news emerged this month concerning what was described as a "gruesome case" of an unregulated treatment that went wrong and a step-up in legal action against a La Jolla clinic. 

Canada this week also told dozens of clinics to stop selling unproven stem cells.

California is the location of the largest number of these dubious clinics in the United States, according to UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota. The total nationally is currently believed to be more than 1,000. 

State legislation to regulate them is on the shelf in Sacramento. The state medical board formed a two-person task force last July to address the matter. The task force only recently held its first meeting on June 27. 

Queried by the California Stem Cell Report about the status of the board's work, Carlos Villatoro, a board spokesman, said this week, 

"There will be an update on the Stem Cell Task Force at the August meeting, as the Task Force has met. In addition, an interested parties meeting is being scheduled for early September."

The task force met with no public notice, which Villatoro said was not legally required. 

Villatoro has said that the board does not regulate clinics -- only physicians and some other medical professionals. The board describes itself as a consumer protection agency. 

(Here are links to what the board describes as a "complete listing" of laws dealing with its regulatory powers: California Law and Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons.)

The board meeting next month will be in Burlingame Aug. 8 and Aug. 9.  The agenda has not been posted, but the meeting is expected to streamed on the Internet. 

More News Reports on Halt in California Stem Cell Funding Applications

The journal Science this week joined the publications beginning to report on the financial travails of the $3 billion California stem cell agency. 

In a piece by Jocelyn Kaiser, the journal briefly summarized the agency's activities and its outlook for the future. Kaiser wrote, 

"Some researchers who explore the basic science of stem cells had already been looking for other funding sources as (the agency) began to emphasize clinical work and their support wound down. But others, especially those planning clinical trials, will be hit hard.

April Pyle, UCLA photo

"'It’s going to be a huge impact on my lab and many others if they end,” says April Pyle of UC Los Angeles (UCLA), whose 11-person group works on using muscle stem cells to treat muscular dystrophy. Her last CIRM grant ends in March 2020 and although she also has some NIH funding, it does not support the animal testing and other studies needed to move her work toward a clinical trial."

CIRM is the abbreviation of the official name of the stem cell agency, the California Institute for Regenerative Medicine. 

Pyle has received $4.6 million from CIRM and UCLA $289 million, according to the agency's figures.

Kaiser also wrote, 

"Ongoing payments for approved projects continue, but scientists are already tightening their belts for a funding gap. They are also contemplating the end of a boom in stem cell research in the state. California’s voters may be asked to renew CIRM with another bond initiative next year, 'but there’s no guarantee,' says Arnold Kriegstein, who heads a stem cell center at the University of California (UC), San Francisco, and has received CIRM funding in the past."

Kriegstein has received $4 million from CIRM and UC San Francisco $192 million.

The shutdown of CIRM applications was first reported by the California Stem Cell Report on June 20.

Others have recently followed, in one form or another, including The Scientist, Genome Web, Capitol Weekly, National Review, The Beacon, Spine Review and LifeNews.

Live Online: The 'Inside Scoop' on $3 Billion, California Stem Cell Research Effort?

The headline was provocative, and the question was "now what?"

It is the latest posting on the blog of the $3 billion California stem cell agency, which expects to run out cash for new awards as early as this fall. 

"Getting the inside scoop on the stem cell agency" -- That was the headline for the article, which promoted an online event July 25 involving three of the directors of the nearly 15-year-old agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

"Now what?" is one of the questions they will address during the Facebook Live session. Viewers will have a chance to submit questions during the event and hear the answers. The immediate response is one of the benefits of such an event. Another is that they are preserved online for later viewing, multiplying the potential exposure in a significant way. 

That staying power is a benefit of considerable utility for the agency, which is not exactly a topic at the breakfast table in the homes of California voters. But they are the folks who the agency hopes will approve a proposed ballot initiative in November 2020 for an additional $5.5 billion for the research program. 

CIRM is currently engaged in a bit of an extra effort to educate Californians about the positive aspects of its work. In recent years, it has functioned in the usual obscurity enjoyed by most state agencies. However, unlike most state agencies, it does not survive financially on the usual budgetary process. 

CIR was born in 2004 with $3 billion, but nothing more.  So today the task is demonstrate to the people of California its value proposition. 

Taking up that task online in a couple of weeks will be CIRM directors Anne Marie Duliege, executive vice president and chief medical office Rigel Pharmaceuticals; Joe Panetta, president of BIOCOM, and Dave Martin, chairman and CEO of AvidBiotics. And CIRM is inviting Californians to join in the Facebook Live session "to understand how we got where we are, how the rest of the field is doing and what happens next."

The California Stem Cell Media Mix: 'Not Meant to Last Forever'

The Scientist magazine this week caught up with California stem cell matters, declaring that state stem cell agency "was not meant to last forever."

The piece by Chia-Yi Hou was a brief overview of California's stem cell agency, bringing the magazine's readers up-to-date about the current condition of the $3 billion research effort. 

"The California Institute for Regenerative Medicine (CIRM) was not meant to last forever, as it received a finite amount of government funds when it was formed," she wrote, referring to the stem cell agency by its official name.

Noting that the program was slow to begin its spending, The Scientist article continued, 

"Eventually, research ramped up and, with the help of CIRM, California has become a hotspot for the field. CIRM helped start stem cell labs in California and attract investments from pharmaceutical companies. 'I think it launched the whole field,' says stem cell researcher Jeanne Loring of Scripps Research in an email to The Scientist. 'At a time when the [National Institutes of Health] was not supporting much translational research using pluripotent stem cells, CIRM was investing heavily in that area.'" 

The piece said,

"Where CIRM funding has been crucial is funding preclinical studies that help get research 'from the bench to the bedside,' says stem cell and gene therapy researcher Stephanie Cherqui of the University of California, San Diego, who is the recipient of two awards totaling more than $17 million. Not many granting agencies have the means to provide millions of dollars to fund the toxicology, pharmacology, and manufacturing studies that are required by the US Food & Drug Administration before potential treatments can go into clinical trials, according to Cherqui."

USC vs. UC San Diego: Unprecedented $50 Million Settlement in Academic Recruiting War

The University of Southern California in Los Angeles is coughing up $50 million and publicly apologizing for its tactics in recruiting a star Alzheimer's resarcher from UC San Diego, it was reported Thursday.

The Los Angeles Times story about the unprecedented settlement described the case as an "ugly academic war." It had the potential of bringing $340 million in research grants to USC.  

The move settled a $185 million lawsuit that at one point involved two directors of the $3 billion California stem cell agency, along with researcher Paul Aisen.

The Times story said the "unprecedented litigation in which UC accused its private rival of repeatedly stealing away top scientists and their lucrative research grants with 'predatory' practices and a 'law-of-the-jungle mind-set.'"

Aisen was a neurology professor at UC San Diego. He and his lab staff left the La Jolla school in 2015. The Times reported that the departures were secretly orchestrated by top administrators at USC.

The Times story, written by Harriet Ryan and Teresa Watanabe with additional reporting by Bradley Fikes, said,

"The self-described 'quarterback' of Aisen’s recruitment was then dean of USC’s Keck School of Medicine Carmen Puliafito, subsequently revealed to have been using drugs and partying with criminals during the time he was courting the scientist."

At the time, Puliafito and David Brenner, dean of the UC San Diego medical school, were both members of the governing board of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known. Aisen, however, has not received funding from CIRM, which has financed $56.5 million in other Alzheimer's research. 

According to the Times, the apology said that the recruitment tactics "did not align with the standards of ethics and integrity which USC expects of all its faculty, administrators and staff."

The Times story continued,

"UCSD Chancellor Pradeep Khosla welcomed the settlement and said he was open to working with USC in the future.
"'For California and the country, it’s good that two great research universities can work on the Alzheimer’s problem,' he said in an interview. 'I look forward to a constructive collaboration in the future in solving other societal problems.'
"It is not unusual for professors to move to other institutions, but it is often a collegial process in which the universities work together to transfer grants and research."

The Aisen case was not the first instance of USC researcher poaching. The Times wrote,

"In 2013, Puliafito lured two well-funded brain researchers from UCLA, outraging the state university, which complained to government regulators. USC agreed to pay UCLA more than $2 million in a confidential settlement."

California Stem Cell Agency: 'Inarguable' Source of Hope, Says Article in Scientific American

The headline this morning on the Scientific American web site said:

"A Bulwark against Trump's Stem Cell Ban

"California's Institute for Regenerative Medicine, a kind of mini-NIH, does crucial basic research without federal funding"

Authored by Zachary Brown, a researcher at UC San Francisco, the article used as a peg the Trump administration restrictions on fetal research funding. Brown contrasted those restrictions to work being done here in California financed by the state stem cell agency. 

Brown recalled that a major impetus for voter creation of the agency in 2004 was presidential restrictions on federal backing for human embryonic stem cell research. Brown wrote,

"The future of embryonic stem cell research appears uncertain once again, as researchers are forced to scramble to adjust to arbitrarily changing norms uninformed by science."

Brown said,

"Almost 15 years have passed since Proposition 71 became law, and California voters made a three-billion-dollar bet on the promise of stem cell technology. At the time of its passage, the policy proposal was as groundbreaking as it was subversive."

Subversive because it challenged the "very relevance" of the predominant federal funding model. 

Brown continued,

"The measure was not perfect. Robert N. Klein II, one of the largest donors in support of Proposition 71, ended up as head of the governing body for seven years, and questions concerning bias in the disbursement of its ample endowment linger — curiously, more than 90 percent of awards" have gone to institutions with ties to governing board members.

"However, its role as a source of hope, both symbolic and realized, for the field of stem cell research is inarguable. The federal government weakens the image of the U.S. as a hub for discovery and medical ingenuity every time it prioritizes political gain over scientific progress."

Hard News for Patients, Scientists: California Shuts Down Applications for Its Stem Cell Research Funding

The California's stem agency's rundown on its clinical
trials. Some of the trials have saved lives. 

The $3 billion California stem cell agency today served up the bad news with only a smattering of sugar coating.

No more applications for research funding are being accepted. The cash is running out, perhaps as early as the end of August.

In a posting on its blog, The Stem Cellar, the agency declared,

"It’s never easy to tell someone that they are too late, that they missed the deadline. It’s particularly hard when you know that the person you are telling that to has spent years working on a project and now needs money to take it to the next level. But in science, as in life, it’s always better to tell people what they need to know rather than what they would like to hear."

The news is no surprise to persons who follow the agency. But today brought a more clearly emerging sense of finality.

The California Institute for Regenerative Medicine (CIRM), as the agency is formally known, was created in 2004 by voters who also provided $3 billion in bond funding. However, the CIRM ballot measure also contained the seeds of destruction for the agency. No other cash was provided. No other significant means of funding was laid out.

Today, the agency is pinning its hopes for survival on a yet-to-be-written ballot initiative for the November 2020 ballot. To bridge the gap between now and then, CIRM has been attempting for months to raise privately more than $200 million. So far, no results have emerged publicly. 

As of last month, the agency had in its pipeline applications for $88 million in research funding. But it had only $33 million left for new awards. 

CIRM reports it has enough cash on hand to administer its portfolio of awards, which stretch out a couple of years.

Fifteen days ago the agency quietly announced the application shutdown. Little public notice of the action was taken even in California's stem cell community, which has grown mightily over the nearly 15-year life of the agency. 

During that period, CIRM has helped finance 55 clinical trials targeting diseases ranging from cancer and heart disease to diabetes and arthritis. It has served up 1,015 research awards. The scientists it has supported have published more than 3,000 research papers. 

However, CIRM has yet to fulfill the campaign-generated expectations of the 7,018,059 voters in 2004 who voted to create it and who thought they would see new, widely available, miraculous cures. Impressive results, some of which have saved lives, have surfaced from some of the clinical trials. But the elusive stem cell cure that would be ready for the general public is yet to hit the streets.

The Oakland-based agency is not done yet nor is it out of business.  Its reviewers are expected to meet later this month to make the de facto decisions on some of the pending applications. And then again in August. 

More needs to be done in terms of the private fundraising effort. And more needs to be done in crafting a new ballot measure that would bring $5.5 billion to CIRM.  

In the CIRM blog item today, written by Kevin McCormack, senior director of communications, the agency declared, 

"Over the years we have built a pipeline of promising projects and without continued support many of those projects face a difficult future. Funding at the federal level is under threat and without CIRM there will be a limited number of funding alternatives for them to turn to.

"Telling researchers we don’t have any money to support their work is hard. Telling patients we don’t have any money to support work that could lead to new treatments for them, that’s hardest of all."

Beyond Blastocysts: 'Simple Stories' and Stem Cell Research Funding

The California stem cell agency this week had some useful advice for telling the stem cell story, be it in Keokuk, Ia., or La Jolla, Ca. 

It is not necessarily just a matter of petri dishes and blastocysts.  It is a matter of "simple stories that illustrate what you did and who it helped or might help."

The advice came from Kevin McCormack, senior director of communications for the California stem cell agency, in an item on the agency's blog, The Stem Cellar. 

The piece grew out of a panel at the meeting this week of the International Society for Stem Cell Research in Los Angeles. McCormack began by briefly recounting the experiences of researchers who carried their pitches into legislative and Congressional arenas.

Those are places where the money is -- the lifeblood of scientific research. 

Money, incidentally, is of particular interest at California Institute for Regenerative Medicine (CIRM), as the $3 billion agency is formally known. On Monday it will shut down applications for new awards because in a few months it expects to run out of cash for them. 

Here is a little of what McCormack had to say concerning communication and scientific research, drawing from the ISSCR panel.

"(P)resenters talked about their struggles with different issues and different audiences but similar experiences; how do you communicate clearly and effectively. The answer is actually pretty simple. You talk to people in a way they understand with language they understand. Not with dense scientific jargon. Not with reams of data. Just by telling simple stories that illustrate what you did and who it helped or might help.

"The power of ISSCR is that it can bring together a roomful of brilliant scientists from all over the world who want to learn about these things, who want to be better communicators. They know that much of the money for scientific research comes from governments or state agencies, that this is public money, and that if the public is going to continue to support this research it needs to know how that money is being spent.

"That’s a message CIRM has been promoting for years. We know that communicating with the public is not an option, it’s a responsibility. That’s why, at a time when the very notion of science sometimes seems to be under attack, and the idea of public funding for that science is certainly under threat, having meetings like this that brings researchers together and gives them access to new tools is vital. The tools they can 'get' at ISSCR are ones they might never learn in the lab, but they are tools that might just mean they get the money needed to do the work they want to."

Leader of Global Research Group: California is 'Hotbed' of Stem Cell Activity

The man slated to be president of the world's largest group of stem cell scientists this week declared that California's stem cell agency has "really accelerated" the work that has made the  state a "hotbed" in the field.

In an interview in the Los Angeles Times, Deepak Srivastava,

Deepak Srivastava
Gladstone photo

also president of the Gladstone Institutes in San Francisco, provided a primer on stem cell research. He said,

"California is a hotbed of activity in the stem cell research world. The California Institute for Regenerative Medicine(CIRM) has really accelerated so much of this. We thought this international community of leaders ought to converge at this major hub in L.A.

"Many people talk about the semiconductor being the dominant discovery in the last 50 years. Now, many think biotech will be the major driver of advancements in the coming 50 years. California promises to be an epicenter for that."

Srivastava has received $17.8 million in research funding from CIRM. Gladstone has received 32 grants totaling $56.4 million.

The occasion for Srivastava's remarks is the annual meeting this week of the International Society for Stem Cell Research in Los Angeles. Srivastava is the incoming president of the organization. The meeting has drawn about 4,000 participants but little major news coverage so far. 

The light coverage is not surprising given that much of meeting deals with quite technical issues. The Los Angeles Times piece was an attempt to demystify the field for the general reader. 

For the $3 billion state stem cell agency, the session was an opportunity to tell its story to a broader research community, including the fact that expects to run out of cash for new awards this year. CIRM is hoping that voters will re-fund it with $5.5 billion in November 2020. Next week it is closing off applications for any further awards this year.

One of ISSCR's concerns is the need for strong funding for stem cell research.

A Stem Cell Crossroads in California: The Viewpoint From USC

The University of Southern California, co-sponsor of a meeting this week in Los Angeles of 4,000 stem cell researchers and others, has offered up a perspective on its program and the crossroads facing California. 

The lengthy piece by Gary Polakovic captured more than the work being done USC, which has received $111 million in funding from the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

He touted the program at USC but also looked at the state of stem cell affairs in the Golden State.  

Keying off the annual meeting of International Society for Stem Cell Research, Polakovic, research communications manager at USC, wrote, 

"California has proven fertile soil for stem cell research. The state has assumed a leadership role in stem cell science since voters approved Proposition 71 in 2004, which seeded the industry with $3 billion in bond funds. The program is administered by CIRM, which contributes about 30 percent of USC stem cell funding."

The article continued, 

"With progress comes growing pains, and California’s stem cell program is at a crossroads.

"On one hand, gains in the lab have moved stem cell therapies closer to making a significant impact on medicine. Yet, the complexity and cost of cellular medicine has proven a big challenge. Scientists acknowledge it will be difficult to cure major diseases with stem cells. The gap between hype and hope has narrowed, but not closed.

"'Hype can be right, but it’s the time frame when people

Andrew McMahon, USC photo 

expect things to happen that can be wrong,' (Andrew) McMahon (director of the USC stem cell program) said. 'Curing cancer, diabetes, Alzheimer’s and other diseases is taking longer and involves a lot more complication and funding. The progress has been astounding — but it’s never fast enough.'"

Polakovic also tackled the difficult financial condition of the state stem cell agency. He wrote, 

"State funding for stem cell research under CIRM is expected to run out this year. The $3 billion ballot initiative that voters approved — Proposition 71, the California Stem Cell Research and Cures Act — is substantially depleted. Other sources, such as federal funding, private investment and philanthropy, are available but not necessarily dedicated to statewide research. CIRM funds have played a big role in creating and sustaining the USC stem cell initiative.

"Researchers are hopeful California voters will have an appetite to continue funding. Backers of Proposition 71 are planning a $5 billion measure for the November 2020 ballot. With research gains and clinical trials underway, backers are hopeful California will continue to support progress for another decade.

"Yet, voter perception of stem cells could be colored by rogue clinics peddling dubious wonder cures like snake oil. Those businesses operate outside the realm of leading research institutions such as USC. More than 100 such stem cell clinics operate in California alone. The Food and Drug Administration is stepping up enforcement actions against clinics offering unapproved stem cell products that endanger the public.

"At the same time, the momentum toward stem cell therapies at USC and other universities is undeniable. On the trail to finding breakthroughs for big diseases, basic research has unlocked a host of co-benefits — many unforeseen when California embarked on its stem cell program 15 years ago — that are valuable to medicine."

$30 Million for Stem Cell Research at UCLA, USC and UC San Francisco

The Broad Foundation today announced it was giving a total of $30 million to UCLA, UC San Francisco and USC to support "life-changing" stem cell research. 

Today's gifts bring to $113 million the total that Broad has donated in California since 2005 to help develop stem cell breakthroughs.

"Today’s $30 million announcement comes as funding for scientific research is declining and researchers are finding it increasingly difficult to secure federal grants," the Broad news release said.

“With (these institutions') commitment to identifying potential treatments for cancers, heritable disorders, and more, we believe (their) centers will continue to make life-changing medical breakthroughs that will impact the lives of people around the world.”

The foundation began its funding of stem cell research

2010 ribbon-cutting for USC stem cell
research building. Edythe and Eli
Broad, (center) flanked by then
Gov. Schwarzenegger (left) and then
CIRM Chairman Bob Klein(right). Broad
and CIRM helped to finance the facility.

in 2005, the year after California voters created a $3 billion stem cell research agency called the California Institute for Regenerative Medicine (CIRM). Today CIRM is running out of cash for new awards. Last week it cut off applications for new funding.

The Broad release said that since 2005,

"(S)cientists at the Broad-funded stem cell centers have developed a cure for the genetic immune system deficiency commonly known as the 'bubble baby' disease and launched clinical trials for treatments of cancer, blinding eye diseases, spinal cord injuries, HIV, sickle cell disease, and other life-threatening blood disorders."

At UCLA, some of the funding will go to advance "promising therapies across the so-called 'valley of death,' where a lack of funding often prevents the translation of promising laboratory discoveries into clinical trials."

The valley of death is also a particular focus of CIRM because of the difficulty in funding research at that stage.

At UCSF, the release said funds will back "initiatives to better understand and potentially cure developmental disorders" as well as supporting a "broader effort to dissect the molecular and genetic origins of heritable diseases for which early intervention may be possible."

At USC, funds will support "the center’s core facilities and training programs, enable recruitment, and attract collaborative research funding to apply stem cell-based technologies to the challenge of age-associated diseases."

Eli Broad founded two Fortune 500 companies, SunAmerica, Inc., and KB Home.  He and his wife, Edythe, are major philanthropists both in science and art, backing two foundations with assets of $2.7 billion. 

They have particularly supported the advancement of stem cell research in California, the foundation web site said. The organization has previously made large gifts to all three institutions receiving awards today. 

The three are also major beneficiaries of funding from the state stem cell agency, ranking among the top 10 recipients.

The ISSCR, California Stem Cell Financing and Silence

It comes as no surprise that the largest organization of stem cell scientists in the world is in favor of "rigorous funding" for stem cell research and warns of the perils of decreased financial support. 

That organization is International Society for Stem Cell Research (ISSCR), which is meeting in Los Angeles later this week and expects 4,000 persons to attend. 

California's stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), has long been a supporter of the ISSCR. In 2009 it contributed $200,000 to help out with the ISSCR's annual conference. 

Times have changed, however, since those halycon days 10 years ago. It is running out of cash for new awards. This year CIRM contributed "only" $50,000 to help stage the group's annual meeting. A few days ago it cut off applications for new research awards beginning next Monday. It needs support for $200 million in private "bridge" funding to continue its program while it awaits what it hopes will be voter approval in November 2020 of re-funding the agency. 

What does the ISSCR have to say about the state of the California stem cell agency?

Anne Nicholas, director of communications for ISSCR, was asked about the situation last week by the California Stem Cell Report. She replied,

 "We don’t have anything to add to your story at this point."