Alpha Clinic Session Streaming Live Today

The symposium on Thursday dealing with California's Alpha stem cell clinics will be available online or via a phone connection that day and also later on YouTube later.

Here is the information provided by the City of Hope, which is hosting the one-day event, on accessing the proceedings, which involves a $40 million effort by the California stem cell agency. You can find the agenda here for some idea on the timing of each segment and speakers.

Click the link below Thursday to join the webinar:

https://cityofhope.zoom.us/j/193680670

Or iPhone one-tap (US Toll): +14086380968,193680670# or +16465588656,193680670#

Or Telephone:

Dial: +1 408 638 0968 (US Toll) or +1 646 558 8656 (US Toll)

Webinar ID: 193 680 670

International numbers available: https://cityofhope.zoom.us/zoomconference?m=rHRfXr-NQJ9VHlWI_6V4iao8Z4JbxpqJ

California's Alpha Clinics: A Unique, Stem Cell 'Clincher' for Patients, Doctors and Researchers

California's $3 billion stem cell agency this week explored the status of its ambitious Alpha Clinic network, touting its impact and progress over the last two years involving hundreds of patients.

The network, which now has bases only in Southern California, is slated to add two more this year in what will be a $40 million investment by the state of California. It is likely to be a major part of the legacy of the California Institute of Regenerative Medicine or CIRM, as the Oakland-based stem cell agency is formally known. The agency runs out of cash for new awards in 2020.

Geoff Lomax, senior officer for CIRM's strategic initiatives, yesterday wrote about the Alpha network in an item on the agency's blog, The Stem Cellar.

He noted the state’s position as a world leader in stem cell research, helped mightily by the efforts of the 12-year-old agency. He wrote,

“But the real clincher is that California has something that no one else has: a network of medical centers dedicated to stem cell-based clinical trials for patients.”

Lomax, who was one of the first employees at the agency in 2005, said,

“So far, hundreds of patients have been treated at our Alpha Clinics. These top-notch medical centers use CIRM-funding to build teams specialized in overseeing stem cell trials. These teams include patient navigators who provided in-depth information about clinical trials to prospective patients and support them during their treatment. They also include pharmacists who work with patients’ cells or manufactured stem cell-products before the therapies are given to patients. And lastly, let’s not forget the doctors and nurses that are specially trained in the delivery of stem cell therapies to patients.

“The Alpha Clinics Network also offers resources and tools for clinical trial sponsors, the people responsible for conducting the trials. These include patient education and recruitment tools and access to over 20 million patients in California to support successful recruitment. And because the different clinical trial sites are in the same network, sponsors can benefit from sharing the same approval measures for a single trial at multiple sites….

“This collective expertise has resulted in a 3-fold (from 12 to 36 – two trials are being conducted at two sites) increase in the number of stem cell clinical trials at the Alpha Clinic sites since the Network’s inception.”

The agency is seeking applications to open two more Alpha Clinics this year, funding them with $8 million each. One of the criteria is geographic diversity. The application deadline is May 15.

In just 13 days, folks interested in Alpha Clinics can take part in a one-day symposium at the City of Hope in the Los Angeles area, which is one of the current Alpha sites. Advance registration is requested for the free event.

The other Alpha sites are at UC San Diego and UCLA/UC Irvine.

$15 Million California Stem Cell Agency Award to Firm Lacking Stem Cell Experience

California's stem cell agency is set to award a key, $15 million contract to a yet to be identified business despite an acknowledgement that the firm "lacks expertise in stem cell clinical and product development."

The five-year award is aimed at helping to make California a world leader in clinical application of stem cell research. It is also linked to the ambitious Alpha Clinic program of the California Institute for Regenerative Medicine (CIRM), as the Oakland-based stem cell agency is known. All CIRM projects initially will receive preferential treatment from the awardee although other outside efforts will be serviced later.

The winning firm is supposed to provide regulatory, operational and consultative services to clinical trial sponsors and "accelerate the regulatory review process and the conduct of high quality clinical trials using stem cell treatments," an agency document said.

The agency's blue-ribbon, out-of-state reviewers gave the firm's application a score of 89 out of 100 during a closed door meeting earlier this spring, according to a presentation prepared for the CIRM board meeting next week. The cut-off line was 85. The other three applicants fell below that level.

A summary of the review published by the agency said,

"The applicant lacks expertise in stem cell clinical and product development."

It stated,

"While there is a lack of stem cell experience in the team, there is a clear commitment and plan to aggregate stem cell expertise and leverage knowledge gained over time to build a center focused on accelerating progression of stem cell projects toward commercialization."

Concern was also expressed about top level management. The summary said,

"Reviewers were not convinced that the proposed center director is sufficiently experienced to direct the CIRM Accelerating Center. However, there is great confidence in the parent organization, which alleviated some of the concerns."

Nonetheless, the reviewers' bottom line indicated that they believed their qualms could be overcome. The summary said,

"Reviewers thought the applicant to be highly capable of delivering the required core services and establishing and sustaining the proposed CIRM Accelerating Center. More importantly, reviewers thought the applicant had given great thought about how best to partner with CIRM to accelerate delivery of stem cell treatments to patients with unmet medical needs by leveraging CIRM Infrastructure Programs and offering innovative and impactful preclinical and clinical development resources to both CIRM and non CIRM-funded investigators."

It is customary for the agency to withhold the names of winning applicants until the board formally ratifies the reviewers' decisions. That will come next Wednesday at the board's public meeting in Berkeley. The names of competing applicants are generally withheld indefinitely by the agency, although the agency has made exceptions.

CIRM reviewers make the de facto decisions on all applications, always behind closed doors. In the agency's 11-year history, the agency's governing board has almost never overridden a positive funding decision by its reviewers.

The reviewers' economic and professional interests, however, are not disclosed publicly. At most state agencies, financial decision-makers are required to disclose their economic interests.

The review process in this case did deviate somewhat from other past practices.  CIRM applicants are normally evaluated based only on a written submission. In this case, however, applicants were permitted to make a 20-minute, face-to-face presentation to reviewers, who then had a chance to ask questions. The agency's regular practice is to withhold the identity of specific reviewers from applicants.

The goal of the "Accelerating Center" is to speed submissions to regulators and assist with clinical trial management, the tests that are conducted before regulators will approve a therapy for widespread public use. The center is also supposed to deal with data management, biostatistical and analytical services.

It will be a key component in the Alpha Clinics Network, a $34 million CIRM project. The Alpha Clinics were pushed forward with the intent of making the Golden State the global leader in stem cells, although the plan was scaled down financially from an original $70 million. (See here and here for more).

Three centers were funded: a combined project involving UCLA and UC Irvine and one each at the City of Hope in Duarte in the Los Angeles area and UC San Diego.

Here is a link to a CIRM presentation made for applicants in the $15 million Accelerating Center round. Here is a link to the CIRM request for applications.

Here is a link to  CIRM's Alpha Clinics Network page with interviews of some of the leaders in the program.

From Wounds to Regulatory Speed-Up: California Conclave Examines Stem Cell Business and Research

Highlights

The Grafix story

Japanese ambitions

California's Alpha Clinics

Hundreds of representatives of the world’s stem cell community are meeting today and tomorrow in California mulling over everything from pricing to the possibilities of commercial cures.

The occasion is the Stem Cell Meeting on the Mesa 2015 in La Jolla, Ca., and if you are not there, it is still possible to see some of the presentations live and later on video.

Some can be dramatic, including one from Lode Debrabandere, CEO of Osiris Therapeutics of Maryland. This afternoon he pulled up a slide involving an Osiris product called Grafix, which is “a cryopreserved placental membrane that is designed for direct application to acute and chronic wounds.”

The photographs on the slide showed an open wound with an exposed tendon before and after

Osiris/Meeting on Mesa graphic

treatment. Debrabandere said the Grafix treatment led to closure of the wound in five months. He said the patient "is walking around and still has his foot.”

Osiris is the firm once headed by Randy Mills, president of the $3 billion California stem cell agency, known officially as the California Institute for Regenerative Medicine(CIRM). Mills speaks tomorrow morning to the conclave. The agency is one of the major organizers of the three-day session and contributed $50,000 to the program.  Other organizers are the Alliance for Regenerative Medicine and the Sanford Consortium for Regenerative Medicine, which has received $43 million from CIRM.

The conference has received little attention in the mainstream media with the exception of the San Diego Union Tribune. The newspaper's biotech reporter, Bradley Fikes, has filed two major stories tied to the conference.

One dealt with the burgeoning number of stem cell clinical trials. The other explored the ambitious stem cell research effort in Japan. Fikes wrote,   

“In the second half of the 20th century, Japan emerged as a world leader in automobiles and consumer electronics. In the first half of this century, the country plans to do the same with stem cells and regenerative medicine.”

Fikes said the Japanese stem cell market “was estimated at $90 million in 2012, projected to reach $950 million in 2020, $10 billion by 2030 and $25 billion by 2050.”

Fikes also pointed out how the Japanese have streamlined the regulatory process, something that CIRM President Mills thinks the United States should emulate. Last week, Mills was in Washngton, D.C., talking to regulators and others, presumably advancing his case for faster action on stem cell therapies.

On the agenda tomorrow morning is a panel dealing with clinical trials at the Sanford Consortium. The effort is tied to the Alpha stem cell clinic effort at UC San Diego  (see here ), which is funded by $8 million from CIRM. The agency initiated the Alpha program, which totals $24 million, in an effort to develop  a world-leading, one-stop program for stem cell treatment.

The Mesa meeting program said, “The CIRM Alpha Stem Cell Clinic at UC San Diego provides infrastructural strength to enable the complex interaction required for success” in stem cell treatments. 

Openness and Transparency: Backsliding at California Stem Cell Agency

Highlights
$34 million Alpha Clinics involved
Information failure on proposal
Discourages public/researcher participation
California’s stem cell agency this past couple of weeks skidded significantly backwards in its efforts to improve clarity and transparency in its $3 billion operation.

The latest example came this week and involved its ambitious, $34 million Alpha stem cell clinic program at four major California institutions: the City of Hope, UCLA and UC Irvine and UC San Diego. 

A proposed, multimillion dollar project involving the effort was scheduled for action next Tuesday by the Science Subcommittee of the agency’s governing board.  As of early this morning -- only one full business day from the meeting -- the agency had released only nine words about it to the public. Here is the full text:

“Consideration of concept plan for Alpha Clinics Accelerating Center.” 

Opaque is the only way to describe the process. And it was bound to create issues with affected parties, which it has in this case.

Such cryptic notices make it impossible for the public to comment intelligently or otherwise, given the lack of information. The failure to provide the information in a timely fashion also feeds suspicion and distrust.

Clarity is one of the watch words that Randy Mills has invoked in his 15-month tenure at the California Institute for Regenerative Medicine(CIRM), as the agency is formally known. He has done much to sharpen CIRM’s focus and provide additional clarity through his analysis of the agency’s work.  

But failing to provide material in a timely fashion removes more than the shine on his efforts. The meetings of the agency’s directors are CIRM’s most important public events.  They are where patients, advocates, researchers, biotech executives and even the unwashed public can come together to hear and see the board in action and discuss issues informally with directors and the CIRM staff. Attendance should be encouraged – not discouraged. Which is what happens when important information is withheld from the public.

Last Friday the California Stem Cell Report carried an item on another mysterious agenda item, one that involved forgiveness of agency loans and potential royalty revenue, something that was promised in the election campaign that created the agency in 2004. 

That too was a case of missing information until it was much too late for the public or affected parties to make thoughtful comments. (See here and here.)

CIRM can and should do better than this. 

(The California Stem Cell Report this morning asked CIRM for comment on the failure to provide information on the Alpha proposal scheduled for Tuesday.  About ninety minutes later, CIRM spokesman Don Gibbons responded, saying that the item was now being postponed "to allow more time for refinement and consideration.")

(By this afternoon, the agency had also posted the first explanation of another cryptic item on the Tuesday agenda for the Science Subcommittee. This one would eliminate the specific schedule for RFAs in the upcoming basic research (discovery) and translational RFAs. The reason for the change is to provide more flexibility.)

(Editor's note: The last paragraph of this item was added several hours after the original posting.)

Sunlight on California's Stem Cell Loan Effort; Info Missing on Changes in $127 Million Research Programs

Highlights

Some details on loan changes

New Alpha clinic center proposed; no details

Unspecified changes upcoming in $93 million award programs

A little sunshine popped up over the weekend on a bit of fiscal alchemy at the $3 billion California stem cell agency, and a little clarity emerged.

The matter involves the agency’s loan program, which affects multi-million awards to businesses. The awards are called loans but are forgiven if no viable product emerges.

The matter surfaced as a result of a cryptic agenda item for Thursday’s meeting of the agency’s directors’ Intellectual Property Subcommittee. Here is what happened:

About a week ago, the agency posted the agenda for the meeting. The agenda contained a 24-word line that said that it was going to change its policies “to permit existing loan recipient whose loan has been forgiven to convert its award to a grant.”

The need for change and its financial impact on the agency was not discussed. The specific language being changed was not spelled out. The timetable for the changes was not specified. Nor was it discussed whether the move was desired by any recipients of the agency’s largess.

Given the opaque nature of the agenda item, the California Stem Cell Report carried an item Friday morning that said,

“In just four business days, the $3 billion California stem cell agency is going to perform a bit of financial alchemy. But like most alchemists, its methods are less than transparent.” 

Much later that day or possibly early Saturday, the agency posted a brief memo and regulatory language that provided a better look at the loan rule changes, which could have an impact on royalties the state might receive on a successful stem cell therapy.

Based on what is now on the agency’s Web site, the proposal would clarify what happens if a loan-financed therapy is dropped and then revived, leading to actual revenue. Under existing rules, such a situation could trigger an ambiguous financial burden that would have to show on the company books. And business executives and investors do not like ambiguous financial burdens. 

The memo from the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, said,

“To provide clarity regarding future obligations, CIRM proposes giving existing loan recipients whose loan has been forgiven by CIRM the option to convert their loan to a grant and forego reinstatement of a forgiven loan. In this way, loan recipients will be automatically governed by the revenue sharing (and other) principles of the agency’s intellectual property regulations in the event future revenue streams are realized. This will be particularly important in the event future revenues are realized after CIRM has exhausted its funding.” 

The directors’ subcommittee is likely to approve the change on Thursday. It would then go to the full board at its Sept. 24 in San Diego for action before it enters the state’s regulatory process, which will open it to further public comment.

The Thursday meeting will also take up changes in the “loan election policy” for this year’s $100 million clinical award program. Details on that are still not available as of this morning, but one assumption would be that they are an extension of the proposed loan changes to that particular program.

The weekend’s memo on the loan changes was dated  Aug. 20.  One can only assume that it was lingering on some CIRM executive’s desk for eight days until it was made available to the public, researchers and likely affected businesses.  

Problems with timely posting of agenda material are not new to the agency. In the more distant past, they were significant but have diminished. That is, until this case and others earlier this year.

The agency also has another directors’ subcommittee coming up in just five business days. The session involves two significant, multimillion dollar programs. One proposal calls for creation of an “Alpha Clinics Accelerating Center” in connection with the $34 million Alpha clinics effort.

The other proposal before the Science Subcommittee deals with unspecified changes in the agency’s upcoming, $93 million “discovery and translational” award rounds.

This morning, no additional details were available on those two matters.

The Science Subcommittee teleconference session on Sept. 8 will be based in San Francisco. Interested parties can weigh in at public locations in Irvine, La Jolla, Los Angeles and Duarte. Addresses are on the agenda.

The meeting Thursday of the Intellectual Property Subcommittee is also a teleconference session based in San Francisco. Public locations are available in San Diego, Hawaii, Woodside and Redwood City with two in San Francisco.

The only public access to these meetings is at their physical locations. No participation is available via the Internet.  However, comments may be submitted in advance or later by emailing them to mbonneville@cirm.ca.gov.

California's Stem Cell Program, Brain Cancer and the City of Hope

The City of Hope said yesterday that it has treated the first brain tumor patient at its state-financed Alpha stem cell clinic, part of an ambitious program aimed at creating four one-stop stem cell treatment centers in California.

The City of Hope announced that the unidentified patient was involved in a clinical trial using genetically modified neural stem cells to help deliver chemotherapy to brain cancer cells.

The press release said,

“The aim of this neural stem cell research is to develop a treatment that is more potent and less toxic than existing treatments for brain tumors.” 

 The Alpha Clinic program was created last October by the $3 billion California stem cell agency. It awarded $24 million for clinics involving UCLA, UC San Diego and UC Irvine in addition to the City of Hope, which is located in Duarte in the Los Angeles area.

Karen Aboody, co-leader of the Developmental Cancer Therapeutics Program at City of Hope, said,

Karen Aboody, City of Hope photo

  “Rather than putting chemotherapy through the whole body and possibly causing significant side effects that affect quality of life, the neural stem cells produce active chemotherapy only at the sites of the tumor, killing surrounding cancer cells.”

Maria Millan, who oversees the Alpha program for the stem cell agency, said,

 “This work does more than help just one person. Because they are part of the Alpha Clinics Network, City of Hope is demonstrating how by working together, providing collective expertise, efficiencies and critical resources, we can help accelerate the development of stem cell treatments for patients with unmet medical needs.”

 The City of Hope study now has several patients and is looking for more.­­­­­

Stanford Pulls Its $10.9 Million Alpha Stem Cell Clinic Application

Stanford University has withdrawn its $10.9 million request to the California stem cell agency to create an Alpha stem cell clinic on its campus, along with a complaint that an illegal conflict of interest was involved in reviewing the proposal.

No further details about the alleged conflict were disclosed by the stem cell agency, which cloaks such matters in secrecy.

The Stanford application last October came before the board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. It was pulled from the agenda without a vote shortly before it was to be considered because of the late allegation of a conflict.

The application was to have come again before the CIRM board yesterday but again was removed. Kevin McCormack, senior director for communications, said that both the proposal and the complaint had been withdrawn by the applicant.

McCormack did not disclose the identities of the reviewers in the Alpha round nor the identity of the applicant, which the agency keeps secret. But the California Stem Cell Report has learned that it was Stanford.

The proposal received a low score, 64 or below, from the agency’s blue-ribbon reviewers, all of whom come from out-of-state, and was not recommended for funding. It was a rare loss for the Palo Alto institution, which has been the most successful in the state in winning money from CIRM. It has collected $298.3 million in 90 grants. The figure far surpasses the No. 2 institution, UCLA, which chalked up $215.3 million in 75 grants.

The winners in the $34 million round were the City of Hope in Duarte, UC San Diego and UCLA-UC Irvine. All of the institutions involved have representatives on the CIRM governing board. They are not allowed to vote on applications from their institutions.

In addition to Stanford, the other losing applicants in the round were UC Davis and UC San Francisco. 

See below for a CIRM list of the conflicts of interest in the round involving various directors.

   Conflict List -- Alpha Stem Cell Clinics -- Directors of California Stem Cell Agency

Alpha Clinic Applications Now Being Considered by California Stem Cell Agency

The Alpha clinic awards are now coming up at today's meeting of the governing board of the California stem cell agency.

Earlier today, Randy Mills, the new president of the agency, outlined in more detail his plan to speed up the grant award process beginning next January. His goal is to substantially reduce the time it takes the agency to process an application until a scientist receives funding.

A press release from the agency later said,

“Right now it can take almost two years for a promising idea to go from the application to the final funding stage. That’s just unacceptable,” says Mills. “We are going to shorten that to just 120 days. But we’re not just making it faster, we’re also making it easier for companies or institutions with a therapy that is ready to go into clinical trials to be able to get funding for their project when they need it. Under this new system they will be able to apply anytime, and not have to try and shoehorn their needs into our application process.”

He said the plan would include ongoing funding opportunities each month during which researchers could apply when ready and have their requests acted on within a matter of a couple of months.

He told the board,

"We don't want loitering."

Mills also told the board that 26 percent of the funding of the agency is going for non-cellular research, the sort of thing that is commonly done by Big Pharma and the NIH. He asked for expression of sentiment whether that should  continue.

In a brief discussion, there was little opposition to that continued expenditure.

In 2004, the ballot initiative that created the $3 billion stem cell agency was peddled to California voters on the basis that it would fund human embryonic stem cell research that the federal government would no longer finance. There was no discussion of funding conventional therapies.

(Editor's note: An earlier version of this item carried an incorrect timeline for funding CIRM grants.)

California's $70 Million Alpha Stem Cell Clinic Plan Edging Forward

The $3 billion California stem cell agency is predicting that “human healthcare will be greatly improved” by stem cell research by 2024 and this week is fleshing out some of the details of an ambitious plan to help make that happen.

The effort involves what the agency calls “Alpha” stem cell clinics. The agency said its proposed $70 million, Alpha network will support its own projects along with products developed worldwide and brought to California.

The plan will come before the stem cell agency's standards group tomorrow at a meeting in San Francisco. The agency's staff has recommended alteration of some of the agency's regulations to avoid duplication in connection with review and approval of clinical trials.

The staff document said a workshop earlier this year developed a “consensus that it would be beneficial if the CIRM (the stem cell agency) regulations reflected existing state and federal requirements with regard to delegation of responsibility and avoid unnecessary duplication of effort, such as the IRB (institutional review board) responsibility for the risk and benefit assessment.”

The staff is recommending that “CIRM’s regulatory requirements for clinical research should be modified to avoid duplication of IRB’s responsibility for review and approval of clinical trials.”

The staff also said,

“CIRM’s existing regulatory requirements for notification, review and approval of basic and pre-clinical research appear effective at this time without creating undue burdens. In fact, mature systems appear to be in place to efficiently incorporate ESCRO (embryonic stem cell research oversight) operations into institutional compliance programs.”

Also on the standards group agenda are issues dealing with informed consent by providers of somatic cells “obtained under general (biomedical) research protocols" in connection with iPSC (induced pluripotent stem cell) derivation.

Dubbed the “Discuss Project,” its goal is “to initiate a process designed to develop consensus for the use of previously collected specimens for iPSC research" and to publish "final considerations" in early 2014.

Another item on the agenda tomorrow involves an update on the “progress of CIRM iPSC bank and donor consent protocol.”

Skimpy Coverage of Alpha Clinic Concept Approval

News coverage of approval of the California stem cell agency's ambitious, $70 million Alpha clinic plan has been quite light but does include one article in the Los Angeles Times, the state's largest circulation newspaper.

The concept proposal was ratified last week by the agency's board with RFAs scheduled to be posted in October. The agency is seeking to build a basis for a robust stem cell clinic business in California that would have an international reach and give the state dominance in the industry.

Karen Kaplan's story in the Times last week quoted CIRM President Alan Trounson as saying in 2010 about agency's goals.

“If we went 10 years and had no clinical treatments, it would be a failure. We need to demonstrate that we are starting a whole new medical revolution.”

The stem cell agency was created by voters in 2004 and funded with $3 billion in borrowed money. It will run out of funds for new grants in 2017.

Outsourcing-Pharma.com caught up with the plan this week in a story that said,

“The opportunity to run trails under the well-funded CIRM could be a boon for CROs (contract research organizations)....But the difficulties of handling the stem cells and gathering enough patients to enroll in a trial may prove daunting for whatever company tries to conduct the trials.”

The article also quoted CIRM spokesman Kevin McCormack as saying,

 “No one has reached out to us yet because the specific details of what we are looking for in the clinics have not yet been decided.”

That said, considerable information is available here, here, here, here and here.)

Also reporting on board approval of the Alpha clinic plan was GenNews.

CIRM Posts Alpha Clinic Press Release

The California stem cell agency this afternoon posted its press release on the $70 million Alpha stem cell clinic plan. Here is where it can be found.

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.