Another $23 Million to Recruit Star Stem Cell Scientists to California

California's $46 million effort to lure stem cell research stars to the Golden State was expanded today by another $23 million.

Directors of the stem cell agency approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and Francisco Prieto were among those opposing the move. Prieto declared,

“We are coming up against finite resources. We have better ways to spend our money."

 Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants. 

Those supporting the expansion said that the grants have had a great impact on the field, not only bringing in individual scientists, but accompanying researchers in their labs along with grants from other sources.

The additional funds will go to institutions that have not already benefited from one of the earlier grants in the program. Up to four awards are expected to be made.

The CIRM staff proposal on the plan said,

“A number of California institutions have not yet been able to secure a confirmed Research Leadership award but would benefit greatly from the recruitment of emerging or established leaders in stem cell biology. Participation in the CIRM program could bring additional, exceptional researchers to California, strengthen and synergize with other efforts to build up local sustained research communities in stem cell biology and medicine and provide ongoing leadership at the cutting edge of California regenerative medicine.”

All of the California institutions involved with the winning researchers have representatives on the governing board of the stem cell agency. They are not allowed, however, to vote on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.

Applications are due in January with final approval scheduled for next May. The program is not open to businesses.

$35 Million Research Grant Round to Remove Stem Cell Roadblocks

Directors of the California stem cell agency today approved a $35 million program aimed at removing bottlenecks to pushing stem cell therapies into the marketplace.

The plan would provide grants of up$1.2 million for about 20 awards with competition open to both business and non-profit institutions. Pre-applications are expected to be due in October with approval next summer.

California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project

The California stem cell agency today approved a $70 million plan to create a network of “Alpha” stem cell clinics that is aimed at making the Golden State one of the leading purveyors and developers of stem cell therapies in the world.

The 29-member governing board of the California Institute for Regenerative Medicine (CIRM)adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned whether the plan was premature and whether existing scientific research justified development of the clinics. 

Sherry Lansing, a patient advocate board member and former head of a Hollywood studio, said the proposal is “one of the most exciting proposals that we have ever had in front of us.” She said it was the “beginning of this dream coming true.”

Under the far-reaching proposal, which CIRM President Alan Trounson has been promoting for two years, the agency will finance five stem cell clinics at established institutions in California with grants of up to $11 million. Another $15 million will be allotted for a stem cell information and coordination center. Major matching contributions will be expected from award winners over the five-year terms of the grants.

The effort is aimed at drawing in clinical trials and patients from the around the world and creating a central bank of knowledge, know-how and regulatory expertise. It will also guide efforts to build profits into stem cell therapies and to develop strategies to attract investors and philanthropists. (For more information on the plan, see here, here, here, here and here.)

Trounson said in a statement,

“These clinics have the potential to revolutionize how we deliver stem cell therapies to patients. Stem cell therapies are a completely new way of treating diseases and disorders so we need a completely new way of delivering those in a safe and effective manner. These clinics will help us do just that and the clinical trials carried out in this network will fulfill the agency’s promise of bringing new therapies to patients who need them.” 

The journal Nature Medicine has reported that the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

The CIRM board heard no negative comment on the plan other than the remarks by Samuelson. . However, not everyone sees a need for it. Mahendra Rao, director of the Center for Regenerative Medicine at the National Institutes of Health(NIH) , says its surveys of researchers have not shown a demand for such centers. In May, a researcher at institution that likely would be an applicant filed a blistering, anonymous comment on the California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,

“Another boondoggle for some medical schools but made to order for private operators like for-profit cancer, dialysis, and laser eye specialty clinics that do one procedure.  I can see each of the medical schools gifted with one as they each were gifted with about 25 million dollars for stem cell institute buildings.”

The researcher continued,

“The NIH at various times has tried to organize clinical trials groups with infrastructure, like quick reaction forces, ready to gear up for a new trial at the drop of a hat. They mainly did nothing but suck money, kept staff employed, because there are generally few drugs ready for early human trials and each treatment that is brought along requires a unique contract, ethics reviews, and different facilities, equipment and staff than planned for.  The latest incarnation are CTSAs or CTSIs, clinical and translational science centers funded by the federal NIH that most if not all California medical schools already have.”

The RFA for the proposal is expected to go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan. 

Alpha Clinic Applicant Qualifications

The chart above outlines the criteria for applicants for grants in the $70 million Alpha clinic plan.

Stem Cell Directors Take Up $70 Million Alpha Clinic Proposal

Directors of the California stem cell agency have begun discussion of the $70 million Alpha stem cell clinic plan. The staff is laying out the proposal at this hour.

California Stem Cell Agency Has $577 Million Remaining for New Research Awards Out of $3 Billion

The California stem cell agency has only $577 million left for future research awards over the next four years, its directors were told this morning.

The figure was reported by CIRM staff this morning as part of its regular briefing on the financial status of the research effort, which began work in 2004 with $3 billion that the state is borrowing through issuance of state bonds. The method of funding will cost roughly $3 billion more in interest costs.

The agency expects to run out of funds for new grants late in 2017 and is considering ways to raise cash for future operations..

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Stem Cell Directors Begin Meeting with Report from Alan Trounson

Today's meeting of the governing board of the California stem cell agency began at 9:35 a.m. today with a a report from chairman J.T. Thomas, updating the board on his activities. CIRM President Alan Trounson has now begun his report dealing with stem cell research publications over the last few months.

California Stem Cell Board Meeting Delayed

The business portion of today's meeting of the governing board of the California stem cell agency was scheduled to begin at 9 a.m. PDT. However, that session has been delayed as the board hears a presentation on MS. The business session may begin about 15 minutes or so.

Coming Up: Live Coverage of Today's California Stem Cell Meeting

The California Stem Cell Report will provide live, wall-to-wall coverage of today's meeting of the governing board of the $3 billion California stem cell agency.

At the top of the agenda is a $70 million proposal aimed at creating a string of Alpha stem cell clinics in California that would serve as a foundation for the state's stem cell business. Also on tap are other proposed grant programs, including a $23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into cures.

Stories will be filed as warranted throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in on the meeting via the Internet. Instructions can be found on the agenda.  

Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions

A key panel of the California stem cell agency today balked at approving a plan to ease restrictions on using stem cell lines derived from women who were paid for their eggs.

The proposal had been scheduled to be taken up tomorrow by the governing board of the $3 billion agency, but the board's standards working group delayed action.

In response to a question, Kevin McCormack, a spokesman for the agency, said in an email,

“It was felt that more discussion was needed before moving to a vote so another meeting is going to be scheduled.”

In 2006, the CIRM governing board approved regulations that banned the use of CIRM funds for stem cells lines derived using compensation. That rule would be modified under today's plan, which would permit the CIRM governing board to approve the use of such lines following a staff study evaluating scientific and ethical issues. Their use would be allowed if the lines would “advance CIRM's mission.”

The delay came after four organizations, including the Center for Genetics and Society in Berkeley, argued that the plan is vague and did not adequately address safety issues.

The four-page statement by the groups said that the plan does not appear to have met “numerous concerns” raised in 2009 in a document co-authored by the CIRM staff. Those concerns include long-term risk and ethical issues.

Under the proposal, the groups said that the agency governing board

“...will decide whether to approve a grantee’s request to use a stem cell line created with paid-for eggs on the basis of whether doing so 'will advance CIRM’s mission.' This criterion is much too vague, and doesn’t include consideration of the health or welfare of the women who undergo egg retrieval. Protecting the well-being of women providing eggs is not even mentioned (though perhaps it could be considered as an element of the fifth of five 'factors to be considered by the ICOC(the agency board),' 'whether the donation…was consistent with `best practices’ at the time of donation').”

The standards group also heard from a UCLA researcher who argued on behalf of the change. Kathrin Plath said she and her colleagues wanted to use a paid-for stem cell line from the Oregon experiment that cloned human stem cells.

(An earlier version of this item said the change under consideration would ease restrictions on "purchasing" stem cell lines. The word "purchasing" was changed to "using.")

Here is the text of the statement by the four organizations.

CGS July 2013 Letter Opposing Changes in CIRM Cell Line-Egg Regulations

$70 Million Alpha Stem Cell Clinic Project Garners Mainstream Media Attention

California's $70 million plan for a chain of “Alpha” stem cell clinics today received its first major attention from the mainstream media.

The story came in the state's largest circulation newspaper, appearing this morning on the home page of the website of Los Angeles Times.

The Alpha project would create five clinics around the state and a coordination/information center under a concept that comes before the governing board of the state's $3 billion stem cell agency at its meeting tomorrow in Burlingame, Ca. Funds could be awarded as early as a year from now. (For more information, see here and here.)

Reporter Eryn Brown quoted Natalie DeWitt, special projects officer for CIRM, as the stem cell agency is known, and Maria Millan, a CIRM medical officer. Brown wrote,

“Clinics to conduct trials of stem cell therapies have different needs than clinics designed to deliver conventional therapies, DeWitt and Millan said. They need special facilities for handling the cells safely, as well as imaging equipment to track the cells once they're delivered into a patient’s body.  Some of this infrastructure already exists, but other parts of it still need to be perfected.  Establishing clinics to house multiple trials might create the critical mass needed to get the infrastructure in place, they said....

"Additionally, they said, CIRM hopes that such collaboration would encourage stem cell companies to share information -- speeding their own work and also helping out policymakers and insurers who are trying to figure out how they'll pay for stem cell therapies in the future.”

The Times quoted the California Stem Cell Report as saying last week,

 “The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments.”

The proposal envisions Alpha stem cell clinics at major, established institutions around the state. It is possible that two could be located in the Los Angeles area at institutions such as UCLA, USC, Cedars-Sinai or the City of Hope, all of which have representatives on the stem cell agency's governing board. Other likely locations are in the San Francisco Bay area and San Diego, again at facilities such as Stanford, UC San Francisco and UC San Diego that have representation on the agency board.

Institutions competing for the grants, including businesses, will be subject to closed-door. peer review prior to final action by the full governing board.  

UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers

A UCLA researcher has spoken out in support of a proposal to allow use of California stem cell agency funds to purchase stem cell lines derived from eggs provided by women who have been paid for the service.

Kathrin Plath, an associate professor, said in a letter to the agency that she and her colleagues would like to use a line from the Oregon SCNT experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as a result of regulations that are the extension of a state law that bars use of agency funds for payment for eggs.

The agency's standards group meets later today to consider changing those regulations. The proposal will then go before the full board tomorrow.

Plath, who has received $5 million from CIRM, said,

“In my lab, we are ... interested in understanding what happens to the somatically silenced X chromosome when differentiated cells are reprogrammed by SCNT. The key question is: are these SCNT-ESCs more similar to iPSCs or fertilization-derived ESCs with respect to the epigenetic state of the X chromosome. Furthermore, it has been shown in mouse reprogramming that the active X chromosome becomes deregulated during SCNT-based reprogramming, and we would like to address this problem in the human system as well.

“We believe that the comparison of the epigenetic states between fertilization-derived ESCs, SCNT-ESCs and human iPSCs is important for a better characterization of these cells and understanding of their epigenetic nature.”

Co-vice Chairman of California Stem Cell Agency Remains in Critical Condition

Duane Roth, the co-vice chairman of the California stem cell agency, remains in critical condition with brain injuries following a weekend bicycle accident.

According to a report by Bradley Fikes in the San Diego U-T, Roth's family is preparing for a recovery that will take weeks. Roth is currently in a medically induced coma.

Roth's wife, Renee, released a statement through the UC San Diego Medical Center that said,

“His condition is currently listed as critical. Duane is in the great hands of the university’s doctors and nurses and we are very happy with the outstanding care he is receiving. We do ask that our privacy be respected as Duane heals. We will be in touch to share more.”

The accident occurred Sunday in the mountains east of San Diego when Roth hit a rocky embankment or outcropping and his helmet split open on the impact.

Roth is CEO of Connect, a technology business group. He has served on the stem cell agency board since 2006.

(An earlier version of this item incorrectly described Roth as CEO of Current instead of Connect.)

Correct Link to CIRM Report on Business Aspects of Alpha Clinics

The "Inside Alpha Clinics' Business" item yesterday had a bad link to the CIRM report on the proposal. Here is the correct link.  A thank you to Kevin McCormack of CIRM for pointing this out.

How to Stay On Top of California's Stem Cell Research Cash Cow -- At Least This Week

Persons interested in listening to Thursday's hearing on California's $70 million “Alpha” stem clinic proposal can do so by two different methods via the Internet.

In addition to Internet access, the public can participate in the meeting in Burlingame, Ca., and also at two teleconference locations in Los Angeles. The Internet access does not allow two-way participation.

If you have money in the game, our advice is to attend the meeting in Burlingame. Only a handful of business people and scientists attend the agency's governing board meetings, but they seem to benefit from the information and discussion as well as from the ability to meet face-to-face with CIRM officials and board members.

Of particular interest may be a scheduled discussion of CIRM's goals and direction this year and next along with other proposals that will funnel $128 million to researchers in California, including the clinic plan.

If stem cell agency fans do not have time to sit through the day-long proceedings, they can follow developments via the California Stem Cell Report, which will be covering the meeting live via the Internet and filing stories as warranted.

Instructions for Internet access can be found on the meeting agenda. One method is a relatively straightforward audiocast. The other involves WebEx, which may involve some configuration of your computer. However, the method also shows the Power Point presentations that are used during the meeting and are otherwise not available in advance or on the day of the meeting. They often contain valuable information that informs the discussions of the board of the $3 billion agency.

In either case, you will want to check out the procedures in advance if you have not used them before. The dial-in number for the audiocast is 866-320-4708 with the password of 297273. Here is the link for the WebEx connection: https://cirm.webex.com/cirm/onstage/g.php?d=286602980&t=a&EA=acheung%40c...

As for the teleconference locations, the specific addresses are on the agenda. But you should ask in advance for more information on the Cedars-Sinai location to be sure you can find it on the day of the meeting. The Cedars complex is very large.

Tomorrow the agency's standards group will take up a proposal to allow CIRM grant recipients to purchasestem cell lines derived from eggs from paid donors. Unfortunately, that session is not available either by Internet or teleconference, but only in San Francisco. The proposal is expected to move forward to the full board on Thursday but it could be modified.

Co-vice Chairman of California Stem Cell Agency Hospitalized with Brain Injury

Duane Roth
Connect Photo

Duane Roth, co-vice chairman of the $3 billion California stem cell agency, has been hospitalized in a medically induced coma following a bicycle accident yesterday in the mountains east of San Diego.

Roth hit a rock embankment and broke his helmet, according to news reports. He was flown to the UC San Diego Medical Center, where he underwent surgery to remove a piece of his skull to relieve pressure on his brain, according to an account by Bruce Bigelow on Xconomy.

Bradley Fikes of the San Diego U-T reported that Roth is expected to kept in a coma for at least several days until his condition improves. 

J.T. Thomas, chairman of the stem cell agency, said in a statement,

“Our thoughts, prayers and best wishes for a full recovery are with Duane and his family.”

Roth, CEO of Connect, an organization that supports the technology industry, has served on the governing board of the $3 billion California stem cell agency since 2006. He has been a strong voice for business at the agency and likely would have been active participant in board discussion this Thursday of one of the agency's major initiatives that will benefit business – a $70 million stem cell clinic plan.

Inside the Business in California's $70 Million Alpha Stem Cell Clinic Proposal

Want to know more about the business aspects of a $70 million proposal to create a chain of “Alpha” stem cell clinics in California?

More details can be found in a report from the California stem cell agency titled “Alpha Stem Cell Clinics: Delivering a New Kind of Medicine.”

Among other things, the 23-page report discusses how the plan would guide efforts to build profits into stem cell therapies and to develop strategies to attract investors and philanthropists. Not all of the business questions are answered. However, the report does paint a more complete picture of how the clinics would lead to actual production and marketing of a therapy. Overall, the proposal is aimed at creating a sturdy foundation for the stem cell industry in California, one that surpasses anything found elsewhere in the world.

The stem cell agency's governing board is set to move forward on the Alpha clinics at its meeting on Thursday. This week's action involves approval of the concept with an RFA coming in October. Awards to six recipients could be made as early as July of next year.

The business aspects of the proposal are critical because without a clear pathway to profits no stem cell therapies will be available on anything approaching a significant scale. 

CIRM President Alan Trounson first advanced the Alpha concept two years ago. Last fall the $3 billion agency brought together 70 folks from the stem cell world to ponder the idea and to make suggestions. CIRM's report on the discussions at the workshop served as the basis for the proposal to be considered by its governing board this week. Here are excerpts from the report.

“Workshop participants...emphasized the need for engaged experts who can consider and implement strategies for reimbursement (i.e.generating profits) for stem cell therapies, and to gather evidence for their value and effectiveness that will be important for coverage by payers. Having clear pathways in place will help in building financially sustainable clinics as stem cell therapies gain approval and are implemented as standard medical practice. The Alpha Coordinating Center (funded at $15 million) would work with Accountable Care Organizations (funding gouprs that tie performance to payment) and multi-stakeholder collaborations to generate evidence for informing coverage and payment policies.”

“Incentivizing company sponsors of clinical trials to participate in data sharing will be challenging, and it will be important to protect their interests as appropriate, by respecting confidentiality of proprietary information, while at the same time requiring an appropriate degree of data sharing to advance the mission of the Alpha Stem Cell Clinics Network(five clinics funded at $11 million each). It is interesting to note that at this time, the landscape of disclosing clinical trial results is in flux, and there is increasing international pressure for companies to disclose information on safety and efficacy to the research and medical communities.”

“Alpha Stem Cell Clinics will create unique models for assessing the financial viability of stem cell therapies in a clinical setting. Cost and revenue data may serve as the basis for developing reimbursement options among the public and private sector as therapies accumulate. Identification of reimbursement options can reduce investor uncertainties and encourage further investment by pharmaceutical companies, investors, funding agencies and philanthropists.
“The elements of the Alpha Stem Cell Clinics Network, namely the clinical sites and central coordinating center, will interact with external entities to generate revenue streams that would ultimately ensure financial sustainability independent of CIRM funding (Figure 3).”

“The Coordinating and Information Management Center could develop a fee for service model for its consulting services, and operate like a CRO. Sponsors could choose whether to use the consulting services and whether to use the Alpha Stem Cell Clinics Sites. The Alpha Stem Cell Clinics Sites would generate operating revenue by running the clinical trials and could perhaps support the Center with revenues, as the volume of trials grows and the Network builds steam.

“In a second model, clinical trial sponsors would all contract with the Coordinating and Information Management Center, which would then set prices according to services needed. From this revenue, the Center would pay the Alpha Stem Cell Clinics Sites for costs associated with the clinical trials.

“By the time the CIRM seed money is depleted, the clinics should have established a strong track record and brand for excellence in conducting clinical trials in stem cell therapies, which would attract more clinical trial sponsors, including companies. To have the largest possible impact on healthcare, it will be desirable to increase industry involvement for cell therapies. However engaging corporate involvement could be challenging, given that many cell therapies are not considered patentable, and many of the ongoing trials are conducted in academic settings. It was suggested that the Alpha Stem Cell Clinics Network align as much as possible with corporate “mentality” to maximize corporate participation.

“Overall, the Alpha Stem Cell Clinics Network will help companies increase their 'bandwidth' and run stem cell therapy clinical trials more effectively and successfully. Many companies will already have sufficient in-house expertise for administration and regulatory guidance, and may not need to engage the Center’s consulting services. They would be attracted to the Alpha Stem Cell Clinics Network because of advantages for clinical trials such as benefiting from the collective databases, know-how and experience of the 'brain trust,' positive interactions and lines of communication with the FDA and regulatory experts, positive branding, quality control, accreditation for their trials, access to patient registries for outreach and patient recruitment and, through its clinical trial management resources, help with enrollment.

“Workshop participants also emphasized that attaining reimbursement for stem cell therapies will be necessary for delivering approved therapies into medical practice. It is likely that the business models for at least some of the clinics will resemble bone marrow/HSC transplant clinics, where for stem cell therapies that are proven superior to the standard of care, the clinic will directly receive reimbursement from insurers for the procedure and follow-up care.

“Reaching this point will require advance advocacy and preparation, and the engagement with the CMS at an early stage of product development. It was recommended that the Alpha Stem Cell Clinics Coordinating and Information Management Center should employ experts in reimbursement methodologies to facilitate entry of approved products into healthcare delivery. One workshop participant, Jeff Sheehy(a stem cell agency board member), suggested that early engagement with Accountable Care Organizations (ACOs) could be helpful, given that stem cell therapies offer the promise of cures, which in the long run will offer high value and effectiveness, albeit with ' high front end costs and the necessity of developing the appropriate infrastructure for delivering complex cell based procedures.' Consortiums such as the Green Park Collaborative are being established to develop methodological standards to demonstrate the effectiveness and value of new technologies. These data could be used to inform healthcare payers of the overall benefits of cell therapies and their long-term value, as compared with existing therapies."

“In 2016 and beyond, CIRM will initiate the 'Delivery' phase, in which priorities will be 'facilitating commercialization (and non-commercial adoption, where appropriate) of therapies, advancing therapies to patients, and enabling business models for stem cell-based therapies.' Connecting this network to other networks and centers with a similar mission outside of California will further accelerate the development and delivery of stem cell therapies, through the global exchange of information and expertise. International testing of experimental therapies developed in California will be essential for ensuring their sustainability, as regulatory approval and widespread delivery of these products in major markets throughout the world will ensure commercial viability and sustainability of companies and universities that produce them, which will in turn help deliver returns to investors. Ultimately, establishing a solid foundation for investor engagement will ensure the viability of stem cell therapies as they move into clinical practice.'”

Paying for Human Eggs, Ivan Illich and Jerry Brown

California's pay-for-eggs bill is stalled in a technical parliamentary process as opponents continue to wage their campaign urging Gov. Jerry Brown to veto the proposal, which swept easily through the legislature.

The latest volley against the industry-sponsored measure appeared this week as an op-ed in The Sacramento Bee. The legislation would allow women to be paid for eggs for scientific research. The op-ed piece invoked the philosopher Ivan Illich, a longtime friend of Jerry Brown and much respected by him.

The July 16 article was written by Diane Tober of the Center for Genetics and Society of Berkeley and Nancy Scheper-Hughes, a professor of medical anthropology at UC Berkeley and director of Organs Watch, a medical human rights documentation project.The piece said, 

“The late historian of science and technology, Ivan Illich, warned against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"

The op-ed said,

“Women's research eggs (have) become the hot new bio-product, increasing the profits of the multibillion-dollar-per-year infertility industry at the expense of women's health, safety and possibly, their future fertility. Is this the 'equity' we want for ourselves, our sisters and our daughters?”

In 2003, Brown wrote a remembrance of Illich, whom he first met in 1976. Brown said that Illich

“...bore witness to the destructive power of modern institutions that 'create needs faster than they can create satisfaction, and in the process of trying to meet the needs they generate, they consume the earth.'”

The egg compensation bill (AB926 by Assemblywoman Susan Bonilla, D-Concord) would remove a ban in California on paying women who provide their eggs for scientific research. Currently women who provide eggs for fertility purposes can be paid, sometimes as much as $50,000, depending on the characteristics of the woman providing the eggs. The bill would not alter the ban on using research funds from the California stem cell agency to pay for eggs. However, the agency next week will consider a proposal to allow use of agency funds to purchase stem cell lines derived from eggs through compensation. (For more information on the bill, see here, here and here.)

The egg bill received final legislative approval on July 1. The governor has 12 days to act on the measure once it actually reaches his desk. However, as of this morning, the legislation remained in what is known as the “engrossing and enrolling” process. It could be a routine delay but the process can also be used to manage the flow of legislation to the governor. Brown is currently on a two-week trip to Germany and Ireland and is not expected to return until near the first of August.

(An earlier version of this item incorrectly identified Nancy Scheper-Hughes as with the Center for Genetics and Society.)

California Stem Cell Agency to Commit 20 Percent of Remaining Cash

The California stem cell agency next Thursday is expected to move forward with plans to give away $128 million, roughly 20 percent of its remaining funds.

The programs include the $70 million Alpha clinic plan, an ambitious five-year project that would be one of the $3 billion agency's hallmark efforts. The other “concept” rounds up next week include a $35 million “tools and technology”RFA and $23 million to recruit four more star, stem cell scientists to California.

The agency has committed about $1.8 billion of its $3 billion so far with about $700 million available for future spending. The remainder is going for the agency's administrative expenses. Cash for new grants is expected to run out sometime in 2017. Total cost of the agency's efforts run to about $6 billion because it operates with money borrowed by the state and must pay interest.

The agency is currently engaged in developing a plan to develop new sources of funding with an eye on some sort of public-private model. It solicited proposals in May for help with the effort, with the goal of completing a plan by this fall. At last report, however, the contract with the consultant had not been let.

The “strategic roadmap,” as it is called, is likely to come up at next week's governing board meeting along with a review of agency goals for the 2013-14 fiscal year.

On the agenda is a proposal to modify the agency's ban on use of its funds to purchase stem cell lines derived from human eggs supplied by women who have been paid. That proposal will also be heard by the agency's standards group next Wednesday.

The agency has additionally been busy implementing recommendations from a performance audit in May 2012. The audit said the agency was laboring under a range of problems that include protection of its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance. A staff Power Point presentation seems to indicate that it is making substantial progress in solving the problems identified by the audit.

Next week's meeting will be in Burlingame near the San Francisco Airport. Two remote locations where the public can participate are also available in Los Angeles. Addresses can be found on the agenda.

The California Stem Cell Report will provide live coverage of the meeting based on the Internet audiocast with stories filed as warranted.  

California's $70 Million 'Alpha' Stem Cell Clinic Plan Headed for Approval Next Week

Alpha clinic organizational diagram
Graphic by CIRM

California's stem cell agency next week is likely to approve a $70 million plan to build a taxpayer-financed chain of  “Alpha” stem cell clinics in what could be a major step towards making California the stem cell capital of the world,

The proposal would create five centers at existing institutions or businesses to be funded at up to $11 million each over five years. Also proposed is a coordination and information center that would receive $15 million over five years.

A story in Nature Medicine said that the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

The clinics are expected to draw stem cell projects from the around the world as well as those funded by the $3 billion California stem cell agency. The proposal would be one of the largest single research efforts funded by the agency, formally known as the California Institute for Regenerative Medicine (CIRM) and use about 10 percent of its remaining cash.

The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments. Indeed, one of the objectives of the information center is to divert people from dubious treatments elsewhere.

The plan would fill a “profound gap” in quality information about stem cell treatments, according to a CIRM document, which said,

“By providing this resource, the public and potential patients would be better educated and informed, whether or not they should opt to enroll in clinical trials or approved treatments at any of the Alpha clinics.”

The Alpha concept was first broached two years ago publicly by CIRM President Alan Trounson, a pioneer in IVF research and the IVF business. His proposal has received early and heavy attention on the CIRM website with a video, blog items and a white paper.

The plan has received little critical attention although a researcher from an institution that could be a candidate for an Alpha clinic commented harshly in May on the California Stem Cell Report, calling the proposal “an irresponsible waste”and a “boondoggle for some medical schools.” The researcher, who asked that he/she not be identified, said,

“CIRM will pay for an unneeded infrastructure that will be empty space and staff sitting on their hands 99 percent of the time.  Or worse yet, CIRM will pay but the space will be used for other things, other clinic procedures paid for by insurance.”  

Elie Dolgin's July 8 piece in Nature Medicine quoted Mahendra Rao, director of the Center for Regenerative Medicine at the US National Institutes of Health (NIH), as applauding the concept. However, Rao said he doesn't anticipate the approach being tried nationally soon.

Dolgin wrote,

“Rao regularly asks researchers hoping to advance promising stem cell therapies whether they require additional clinical infrastructure. 'So far, what they've told us is they'll let us know if they need anything more than (the) programs that we have already established,' he says.”

The question of the size of the demand for Alpha clinics is not addressed in the CIRM concept plan. Also absent is much discussion of the business aspects of the proposal. It does mention “corporate sponsors” in passing. In a CIRM blog item yesterday, Natalie DeWitt, special project director at the agency, touched on business elements, declaring,

“(The proprosal) will yield better clinical trial design, accelerated approval of high quality treatments, and data and know-how to inform regulatory and reimbursement decisions.”

Reimbursement is the industry euphemism for creating ways to generate profits for stem cell firms.

The proposal said applicants would have to bring substantial support from their own institutions and “demonstrate the potential to bring in a pipeline of additional stem cell-based therapeutic trials as well as future funding streams to sustain the clinic.” Applicants would also be “evaluated in their ability to create a positive 'brand' that would attract clinical trials.”

Also up in the air was whether grant reviewers, all of whom come from out-of-state, would have special expertise to evaluate the business aspects of each applicant's proposal along with their business track record.

What is before the CIRM directors July 25 at their meeting in Burlingame, Ca., is a request for approval of the concept, which would be fleshed out for the RFA. The governing board almost always approves staff concepts, although they may modify them slightly. A number of directors come from institutions that are likely to be applicants in the program. They can participate in voting on the concept plan but would be barred from voting on any applications that come in later. The two RFAs could go out as early as October with approval of funding of applications one year from now.

In addition to the Burlingame meeting site, members of the public can participate from two teleconference locations in the Los Angeles area. The specific locations can be found on the meeting agenda.

The California Stem Cell Report will provide live coverage of the entire meeting, filing reports as warranted based on the Internet audiocast.

Here are excerpts from CIRM's staff document on the plan.

“To accelerate therapeutic development and delivery of stem cell therapies, CIRM proposes establishing the CIRM Alpha Stem Cell Clinics Network (CASC Network). The network will be designed to support projects emanating from CIRM’s funding pipeline, as well as scientifically outstanding stem cell products being developed worldwide and brought to California. Conceptually, the CASC Network is intended to be a sustainable infrastructure designed to support academic- and industry-initiated clinical trials, and delivery of therapies proven safe and effective.”

“The major thrusts (of the overall plan) will be:
• Development of clinical capacity and associated resources designed to support the effective implementation and execution of clinical trials and delivery of registered stem cell therapies
• Compilation of data and information concerning clinical trial experience and therapy outcomes to further inform the research, regulatory, and general community about the status of investigational stem cell interventions and long-term outcomes
• Dissemination of information to the public and counseling of patients and potential trial subjects about therapeutic options and clinical trials involving stem cells in the network and elsewhere.”

“The long-term vision is for the Alpha Clinics to expand and accommodate a broad array of stem cell-based clinical trials, where the trial meets the scientific, clinical trial design and ethical standards set forth by the Alpha Clinics Network, as well as FDA approved treatments.”

The coordinating and information center would be expected to :
“Build relationships with Accountable Care Organizations, and participate in initiatives for informing coverage and payment decisions
“Design strategies to attract investors and philanthropists to CASC network
“Create business plans, and marketing and branding strategies for financial sustainability of the Alpha Clinics Sites and (the coordination/information center)”.