Wednesday, July 17, 2013

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)”.

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