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."

Turning Off the California Stem Cell Spigot: Will Private Donors Step Up?

Benchmarks are important to the $3 billion California stem cell research program. When scientists fail to achieve them, the flow of cash from the agency disappears. 

Last week, the stem cell agency quietly announced something of a funding benchmark for its own, 14-year-old efforts.

The bad news? In just six days, the agency will shut off  applications from California stem cell scientists and companies for multimillion dollar awards.

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), last Thursday said that its dwindling finances forced the closure. 

CIRM has only $33 million left for new awards and already has requests in the pipeline for $88 million. Private funding is a possibility, but major donors have not yet surfaced publicly.

Immediate reaction to the announcement was muted but ranged from dismay to tributes to the agency and the work it has financed. 

One scientist, Jeanne Loring, chief scientific officer at Aspen Neuroscience in San Diego, said the action was like "a rug being pulled out from under you." Loring also said in an email that the agency has built an "enormous resource in stem cell expertise in California" and played an important role in her own work at Scripps Research. 

Loring's work has received $17.4 million from the agency since 2005. (See the full text of her remarks here.)

Steve Peckman, deputy director of the Broad Stem Cell Research Center at UCLA, said the agency has chalked up "impressive success" and made California an international leader in the field. (See the full text of his remarks here.)

UCLA has received $289 million from the agency. 

Robert Klein, who led the ballot campaign in 2004 that created the agency, said the application shutdown will create a gap that will hold back development of critical therapies. Klein is expected to lead another ballot initiative in November 2020 to provide $5.5 billion for CIRM. (See the full text of his remarks here.)

Klein is chairman and founder of Americans for Cures of Palo Alto, Ca. He was also the first chairman of CIRM. 

CIRM has provided funds to about 600 researchers and 128 institutions and companies. The researchers run labs that vary in the number of employees, but the total would include  hundreds more stem cell workers. 

The agency is currently trying to raise $200 million privately to continue its awards programs between now and the fall of 2020. No philanthropic gifts have been announced. Queried last week by the California Stem Cell Report, the agency said that it had nothing new to report in the fundraising effort that began last year.  

It is unclear how the application shutdown will affect the fundraising effort. It may serve as a prod, however, for some potential donors and help to crystalize decision-making as CIRM executives stress the importance of the agency.

CIRM's announcement left open the possibility of re-opening applications come September. The agency expects to have a better handle then on how much cash might be returning to CIRM from awards that have missed benchmarks. The amount is not expected to be huge. 

The agency has reported that it has enough money to sustain a wind-down of the agency and to administer remaining multi-year grants, should the yet-to-written ballot measure fail. 

Klein is optimistic, however, regarding the prospects for a bond measure 16 months from now.  He told the California Stem Cell Report that unspecified polls show that 70 percent of voters support re-funding the agency when they learn of the "remarkable progress" that has been achieved as a result of CIRM-backed research. 

CIRM Application Shutdown: Text of Robert Klein's Comments

Here is the text of comments by Robert Klein, chairman of Americans for Cures, on the shutdown of applications at the California stem cell agency. Klein was responding to questions from the California Stem Cell Report.

"When Californians learn of the remarkable progress from the California funded stem cell and genetic therapies FDA approved human trials in restoring major function to paralyzed patients, to save the lives of children with severe immune diseases, to restoring sight to patients that are blind, the support for stem cell research and therapy development exceeds 70% in recent polls.

"California’s leadership in cellular and genetic therapies, through its state funded research and human trials, currently supports 51 human trials for a range of chronic disease and injuries, and 24 more human trials are in progress by biotech companies based upon California’s funded research.

"The life-changing and life-restoring work of California’s scientists and physicians will predictably earn the chance for renewed funding. Polls indicate that California voters want the opportunity to vote in 2020 on continuing this visionary California initiative, originally funded in 2004 through Proposition 71, the California Stem Cell Research and Cures Act. The gap in available state funding from the fall of 2019 through November 2020 will hold back additional critical human trials for new life saving and/or disease mitigating therapies; but, I have faith that Patient Advocates and California voters will back new funding at the polls in 2020 and continue California’s remarkable contribution to this medical revolution that effects every one of our lives.

"In advancing the research and therapies, the California research funding agency has also gained broad financial support for its portfolio of research and human trials based on the strength of more than 2850 peer reviewed published medical discoveries and the 75 human trials directly funded or separately funded supporting the California funded discoveries. The matching funds from donors, institutions, private companies and non-profit organizations have already exceeded $3,250,000,000, more than a 100% match on the $3,000,000,000 originally approved in state funding.

"This medical revolution holds the promise of restoring health and quality of life for many of California’s individuals and families suffering from chronic disease and injury. However, the last tactical mile to bring this broad spectrum of therapies to patients will require more funding and the thoughtful support of California’s public as the human trials and discoveries are refined and tested, overcome numerous obstacles or complications, and ultimately serve to improve the life and reduce the suffering of every one of us."

CIRM Application Shutdown: Text of Jeanne Loring's Comments

Here is the text of comments by Jeanne Loring on the application shutdown at the California stem cell agency. Loring was responding to questions by the California Stem Cell Report. She also filed a comment separately on the initial story. 

"CIRM has built an enormous resource of stem cell expertise in California over the last 14 years. They had a big impact on my lab; over the years I was awarded 10 grants on which I was PI or co-PI and several more as a co-investigator, we trained hundreds of researchers in pluripotent stem cell technology through CIRM’s Shared Labs and Training Center grants, I mentored 32 students through the Bridges program, and we published 71 scientific papers with CIRM support (so far). While I also obtained funding from the NIH and private donors, CIRM was by far the dominant supporter of my research.  When I obtained my first grant on human embryonic stem cells from the NIH in 2002, I could not have predicted that I would be able expand on that work so spectacularly. I was in the right place at the right time.

"While I am grateful for CIRM’’s support of my work, I have also been deeply troubled by some of  their decisions. This is not the time or place to dissect their judgments, but if they are rejuvenated by another bond measure, I hope they will call on some of us to share our experiences as they develop their strategy for the future of stem cell research and development in California."

California Application Shutdown: Text of Comments by Steve Peckman

Here is the full text of comments by Steve Peckman on the shutdown of applications by the California stem cell agency. Peckman was responding to questions from the California Stem Cell Report. 

"The inevitable announcement by CIRM serves to highlight the impressive success of Proposition 71 as a catalyst for scientific discovery and the clinical application of stem cell research and regenerative medicine.  Since 2005, CIRM’s trailblazing initiatives from science and ethics training to basic scientific research, biomedical tool development, infrastructure, pre-clinical testing, and clinical trials have made California an international leader in the field.  The pool of scientific knowledge is constantly growing because of the public’s trust and investment in the future.  The forward thinking of California voters through the passage of Proposition 71 has gifted the world with critical biomedical breakthroughs, such as a cure for ADA-SCID (developed by UCLA physician-scientist Dr. Donald Kohn and his team), whose broad impact will inform science and medicine for generations to come.

"As you noted, talk of CIRM’s death is a bit premature as it will still be awarding pre-clinical and clinical research grants in the near term and overseeing research grants and clinical trials for at least four more years."

Stem Cell Video Flap: A Back Story on How the Affair Broke

A San Diego stem cell scientist today shared the back story on development of a stem cell video ruckus earlier this month that snared a dozen or more scientists, including the president of the $3 billion California stem cell agency.

Jeanne Loring, chief scientific officer of Aspen Neuroscience,

Jeanne Loring, San Diego UT photo

wrote about the affair on The Niche, a blog published by UC Davis researcher, Paul Knoepfler.

Her account told how she became aware of the video, Healthcare Revolution, on the morning of Thursday June 13 when she was notified that the video would be released a few days later and included her. Loring wrote,

"I was mystified about how this happened, so Thursday evening I sent an email with the subject 'Help! what do you know about this 'documentary' to the 9 people on the documentary’s website whose emails I had: Bruce Levine, Evan Snyder, Larry Goldstein, Arnie Caplan, Josh Hare, Paolo DeCoppi, Tony Atala, Julie Allickson, and Maria Millan. None of them seemed to know either."

The next day Loring asked the producers to remove her from the video, which they did. Loring's post today said,

"I was very, very relieved. I checked the website later that day, and my photo was gone. Over the next few days I heard from the colleagues I’d contacted earlier, and gradually they too asked to be removed. It was fascinating to watch the 'episode experts' disappear one by one from the website.

"I tried watching one of the newly edited episodes. I was sickened by it and couldn’t watch to the end. I’m so glad I’m not in it."

California Stem Cell Agency Pitches for Support; Los Angeles Event Scheduled Tuesday

Just one day before the California stem cell agency announced it was cutting off applications for more research funding, it made an ardent pitch to the public for increased support. 

The appeal concerned a public event that the agency, formally known as the California Institute for Regenerative Medicine (CIRM), is staging on Tuesday in Los Angeles. 

In an item on the agency's blog, The Stem Cellar, Kevin McCormack, senior director of communications, briefly recounted the $3 billion agency's work. And then he wrote,

 "We still have a lot to do. The problem is we are quickly running out of money. We expect to have enough money to fund new projects up to the end of this year....Some may get funding from other sources, but many won’t. We don’t want to let that happen."

Stem researchers, CIRM leaders and others will be there. McCormack said,

"It’s going to be an opportunity to learn about the real progress being made in stem cell research, thanks in no small part to CIRM’s funding."

On the web page for the event, there was also this:

"You'll hear from a woman whose infant daughter was cured of a fatal immune-system disorder, from the doctor who developed that treatment and from stem cell champions who are worried what will happen to the most promising research if CIRM no longer exists."

 The free, public event will be in the Los Angeles Convention Center, 1201 South Figueroa St., Petree Hall C. The event begins at 6 p.m. but McCormack said CIRM staffers will be there at 5 p.m. to answer questions.

Interested persons can RSVP here. But it is unlikely that anyone will be turned away.

Money Running Out: California's Stem Cell Agency Shutting Down Applications for Research Awards

The $3 billion California stem cell agency, which is running out of cash, today served notice that it would stop accepting applications for more research awards beginning next month.

The low key announcement is another step towards the looming demise of the 14-year-old agency, created by voters in November 2004. Its hopes for continued life are pinned on a proposed bond measure for the November 2020 ballot.

A memo to the governing board from leadership of the agency, formally known as the California Institute for Regenerative Medicine (CIRM), said that it currently has $88 million worth of requests for cash but only $33 million available for awards.  

The memo said, 

"Given the status of applications in the system and expected applications this month, we intend to close application submissions after this month. In the unlikely event that funds continue to be available after processing of all applications in the queue, we may temporarily re-open the submission window as needed."

The matter was taken up this morning at a meeting of the board that approved an $11 million clinical award for a rare disease. 

During a brief discussion, board member Os Steward of UC Irvine said that "shutting off the spigot could be highly disruptive." 

He indicated that he would prefer to call it a suspension of applications. 

Board member Jeff Sheehy said the move is "abrupt but that is kind of where we are."

Under the ballot initiative that created the agency, the only significant source of funding is bonds issued by the state of California. The authority for issuing the bonds is expiring. 

The agency has been trying for months to raise $200 million in private funding. No announcement of any progress, however, was made at today's session. 

The agency has on hand enough funds to handle administration of existing awards for a couple of years. 

Here is the full text of today's memo. 

"For 2019, the ICOC allocated $93 million for clinical program applications (CLIN1, CLIN2, CLIN3) and $30 million for the CIRM/NHLBI collaboration on sickle cell disease. As of June 2019, the available budget for non-sickle cell disease applications is $45 million.  

"Currently, we have one application recommended for funding by the GWG and pending approval this month for $12 million. There are two applications slated for GWG review later this month and three applications that have received a score of “2” by the GWG that are pending reassessment by the GWG next month. We have also received five applications that are undergoing eligibility review. The total request for all clinical applications currently in our system is about $88 million. We are expecting two to three additional application submissions for this month’s deadline, which falls on June 28, 2019. The budget request for these is still unknown. We expect that not all applications will achieve a funding recommendation, but there may be enough to deplete the annual allocation.

"Given the status of applications in the system and expected applications this month, we intend to close application submissions after this month. In the unlikely event that funds continue to be available after processing of all applications in the queue, we may temporarily re-open the submission window as needed. 

"We intend to inform all prospective applicants submitting an application this month that there is no guarantee of an availability of funds and that review of their application may be halted if funds are depleted prior to the completion of their review. We also intend to post notice that application submissions will close after the June deadline until further notice.Ap 

"This action does not affect application submissions for sickle cell disease that are accepted under the CIRM/NHLBI collaborative program."

Stem Cell Video Flap: A Look at the California Firm Backing the 'Docu-Series'

A California physician deeply enmeshed in the national ruckus over a controversial, stem cell video has -- according to his web site -- "achieved world-renown as a pioneer in the area of stem cell research."

He is Mark Berman, one of the co-founders of Cell Surgical Network (CSN), which partly financed the lengthy, online video, "Healthcare Revolution." At least 12 scientists, other experts and institutions reacted with shock last week when they became fully aware of its approach and financing. They asked that they be removed from the film.

Mark Berman,  photo from Berman web site

One researcher called the video an "infomercial." Another said she was placed with "charlatans and thieves."

Berman's firm has been sued by the Food and Drug Administration as part of an effort to curb untested and potentially dangerous stem cell treatments. The number of dubious stem cell clinics has grown sharply in recent years. Estimates are that 1,000 exist nationally, with the highest percentage in California.

On Sunday he emailed the irate scientists and asked them to reconsider their requests for removal. None apparently did. 

What follows is a brief look at Berman's history and that of his firm, which has offices in Beverly Hills and Rancho Mirage, Ca., and about 100 affiliates nationwide and more abroad. 

But first, the text of his response to questions from the California Stem Cell Report about the video and its financing. The "docu-series" was produced by Bobby and Sara Sheehan and their firm, Working Pictures.

"I met Bobby and Sara when they came to interview me at my office for another project they were working on a couple years ago. We were commenting on all the amazing work being done in the field of cell therapy and stem cell research, yet all the surrounding controversy. A lot of this was due to people putting random unmatched cells into patients for a whole host of conditions and not adequately tracking the follow up. We thought it would be really important to show some of the world’s greatest minds, who have devoted, in some cases, decades to advancing this field, and highlight all the great work that’s currently being done to advance healthcare.

"I’m not sure what the entire series cost. We were just a tiny part of this film. Bobby and Sara spent over a year flying around the world to get this project done. they worked completely independently from us. Neither I, nor anyone in CSN, paid anyone that was interviewed or promised them compensation. We have zero financial interest in Working Pictures, nor do they have any financial interest in CSN. 

"This whole project is about educating people on the work being done to advance healthcare and we think it’s important that the word gets out."

Berman's website says he has practiced cosmetic surgery since 1983 and started his stem cell practice in 2010.  He is co-founder of Cell Surgical Network and the California Stem Cell Treatment Center. 

Erin Allday of the San Francisco Chronicle reported last year: 

"For more than three decades, Berman’s focus was breast augmentations and face-lifts. He invented a pocket-like device that can be implanted into the breast to produce better-looking, safer results from augmentation procedures. He calls it his “Sistine Chapel.”

With his business partner, Rancho Mirage (Riverside County) urologist Elliot Lander, Berman has built the largest chain of stem cell clinics in the country. Their Cell Surgical Network has more than a hundred affiliates in 33 states — including 38 clinics in California alone — selling treatments they claim will fix everything from knee pain to symptoms of multiple sclerosis.But over the past eight years, Berman has reached far past his specialty into a realm of highly sophisticated, still-nascent medicine. He’s become one of the country’s most outspoken and notorious providers of so-called consumer stem cell therapies: using human stem cells to treat a wide variety of ailments despite little or no scientific proof that they work.

“As a cosmetic surgeon, it’s kind of a joke that I’m at the center of this universe,” Berman said in an interview last fall (2017). “But I’m kind of ground zero.”

"Seven months later, his words became darkly prophetic: In May, Berman and his partner were targeted by the U.S. Food and Drug Administration. The FDA requested an injunction that, if approved by a federal judge, would stop them from selling stem cell therapies. 

"The FDA issued a similar request against a separate operation in Florida, U.S. Stem Cell Clinic.

"Their clinics, though, are just some among several hundred that have popped up across the country in recent years. They are renegade outposts operating with little legitimacy and oversight at the frontier of what is otherwise a highly promising field of medicine."

Here is a short list of other sources of information involving Berman, his treatments and  enterprises: 

• Stem cell scientist Paul Knoepfler of UC Davis has written extensively about Berman and Cell Surgical Network, going back to 2013 when Knoepfler published this Q&A.
• Vox recently carried an overview of unregulated stem cell treatments, including Berman's firm. 
• A Washington Post story about the 2018 FDA filing against Cell Surgical Network.

Stem Cell Video Flap: A Look at the Firm that Produced the "Docu-Series"

Bobby Sheehan discusses his personal and professional background in this YouTube clip.

Who are Bobby and Sara Sheehan, not to mention Working Pictures? 

It is a question that arises from their controversial "docu-series" that raised a ruckus this week in the small world of stem cell science.

Their online video, "Healthcare Revolution," was an unpleasant surprise for at least 12 scientists and other experts who learned only a few days ago they were appearing in the production. All of them asked to be removed.

They believed that they had been misled about how interviews that they had given many months ago were going to be used. 

They objected to sharing an electronic platform with dubious enterprises that are current targets of the federal government's actions to shut down dangerous and unproven stem cell treatments. 

Executives of those firms also appeared in the video in a manner that was considered a case of "false equivalency."

Earllier this week, the California Stem Cell Report queried Sara Sheehan about the video and their links to a California stem cell firm, Cell Surgical Network, with 100 national affiliates that the Food and Drug Administration is suing. 

The full text of her response runs below. But first a little background drawn from the Internet.

Sara Sheehan is executive producer for Working Pictures, according to its web site.  Her husband, Bobby, is producer, director, writer and cameraman. Their web site says Bobby had a "nomadic and slightly feral" upbringing. It also said, 

Sara Sheehan
 Working Pictures photo

"Collectively, they have produced well over a hundred hours of content in the form of online and conventional TV series, documentaries, and narrative films. Bobby has directed and lensed over 300 commercials…and they have produced three talented children."

The Sheehans are also associated with another enterprise called "Mortal," which deals with death and spiritual awareness. 

The California Stem Cell Report asked Sara Sheehan about the cost of the stem cell docu-series, which was partly financed by Cell Surgical Network, and any other financial ties with that firm.  Here is the verbatim text of her reply.

"I appreciate your asking us to provide additional information and I have answered your questions below: 

"We set out to produce a documentary series about the very complex regenerative medicine landscape. There is a lot of information out there and consumers are faced with a daunting amount of opposing opinions and concerns. We felt that by showing the entire landscape - including advances in research that will be providing hope to patients years down the line, the fact that many consumers are going overseas for treatments, the legislation that has been enacted in this country, patients who have gotten treatments in this country and other countries and their outcomes, and the lawsuits- we would educate the consumers who would see this and allow them to make the best decisions for themselves and their loved ones. 

"We looked for financing for the series, which took a year to make. We had investors, Drs. Berman and Landers (of Cell Surgical Network) were part of that team. Never did they ask to see edits, to control the content or interfere with the story in any way. That was the deal. The rest of the costs we bootstrapped ourselves: our investors did not pay us for our time and we covered many costs ourselves. We are not connected in any other way to Cell Surgical Network or any other regenerative medicine provider, nor do we stand to benefit financially from any procedures or products being marketed. We have no family members connected to Cell Surgical Network or any other regenerative medicine providers. The bottom line is that we are filmmakers who attempted to outline what is clearly a heated and emotionally charged environment. Ironically, Cell Surgical Network is featured most prominently in an episode entitled The Lawsuits, outlining the cases against US Stem Cell and Cell Surgical Network. We had updated that episode to reflect the decision against US Stem Cell. 

"We never paid anyone to be interviewed. In fact I have NEVER paid anyone to be interviewed for this project or any other project.

"After a year of interviewing and editing as many and as varied voices as possible, the resulting series is 12 episodes long. We organized the information by subject and feel we had a comprehensive product that provided a good, basic overview of the field that included many opposing points of view. There is a tremendous amount of information contained in the series that we felt showed as much of the landscape as we were allowed to capture.

"Unfortunately, a number of people expressed concern about being included in the project and we immediately responded that we would honor their wishes to be removed."

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Loring said in a letter to the Sheehans,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Carlos Villatoro said,

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

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

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

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

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

Bernard Siegel, chair of the Summit, said,

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

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

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

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

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

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

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

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

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

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