The Henrietta Lacks Story and Eggs, Money and Motherhood

The legacy of Henrietta Lacks popped up again today in a piece in the New York Times that should resonate among stem cell researchers and within the stem cell industry.

It even has a current hook involving California legislation to permit women to sell their eggs for the purposes of scientific research – a bill that is now on the desk of Gov. Jerry Brown.

The issues in the Lacks saga involve ownership of human cells, trafficking in them and informed consent, all of which surface in one form or another in the state legislation.

But first a refresher on Henrietta Lacks. She was an African-American woman who died in 1951 of cervical cancer at the age of 31. Shortly before her death, physicians removed some of her tumor cells, and, as recounted in today's NYTimes article by Carl Zimmer,

“They later discovered that the cells could thrive in a lab, a feat no human cells had achieved before.

"Soon the cells — nicknamed HeLa cells — were being shipped from Baltimore around the world. In the 62 years since — twice as long as Ms. Lacks’s own brief life — her cells have been the subject of more than 74,000 studies, many of which have yielded profound insights into cell biology, vaccines, in vitro fertilization and cancer.”

But Lacks never consented to her cells' being studied, a situation not uncommon at the time, nor did her family know about the situation until 1973. The complete story was chronicled in 2010 in a best-selling book, “The Immortal Life of Henrietta Lacks," by Rebecca Skloot.

Zimmer noted in today's article,

“For 62 years, (Lacks') family has been left out of the decision-making about that research. Now, over the past four months, the National Institutes of Health has come to an agreement with the Lacks family to grant them control over how Henrietta Lacks’s genome is used.”

The particulars involving her genome are in Zimmer's story. But the article implicitly raises anew questions that make many scientists uncomfortable. Often they contend that the situation involving Lacks could not occur today because of higher ethical standards. Standards ARE higher today. But problems continue to arise in the scientific community, including the sale a few years ago of willed body parts at UCLA for $1.5 million to private medical companies.

Development of products based on human stem cells promises even greater rewards, with billion-dollar blockbuster therapies not out of the range of possibilities. Profit and the desire to record a stunning research triumph are powerful motivators. They can lead to short cuts and dubious practices, such as seen in the Korean stem cell scandals of 2006.

So we come to whether women who donate their eggs for stem cell research can give truly informed consent when they surrender all rights to whatever products may result from parts of their bodies, as is common on such consent agreements. Or for that matter, what about the men who give up adult cells for reprogramming to a pluripotent state? Can they really understand the likelihood of a billion dollar product being generated with the help of their contribution? On the other hand, can the donors also truly understand that they are probably more likely to be struck by lightning than have their body parts result in a medical blockbuster?

These considerations may seem insignificant to some in science. But to grasp their full implications, one only has to read a few of the nearly 200 reader comments today on Zimmer's article today. Here is a sample.

From Frank Spencer-Molloy in Connecticut:

“(T)the Lacks family was robbed. Scores of companies profited to the tune of tens of millions of dollars from products they made derived from Henrietta Lacks' cancerous cells. Maybe this will provide some impetus to a wider consideration of the rights patients are entitled to when their tissues are cloned and disseminated to other researchers and ultimately put to use in profit-making ventures.”

From Robbie in New York City:

“At the very least, this family needs to be financially compensated for the anguish of their discovery and for the time and energy they've put into pursuing their rights. In my opinion, they also deserve a portion of any commercial gain that's been made using the HeLa cells. It is only through having to give away money that the powerful learn manners.”

From Julia Himmel in New York City:

“It is absolutely true that scientists have had a blind spot when it came to the human element of the HeLa cells.”

The pay-for-eggs legislation (AB926) now before Gov. Brown requires informed consent from those who provide eggs. Opponents of the measure, however, argue that truly informed consent from some women could be actually impossible because of economic pressures felt by the women. Writing in The Sacramento Bee last month, Diane Tober and Nancy Scheper-Hughes said,

“Allowing a market in eggs for research would reach beyond the current pool to target women who may be motivated by dire need. How many low-income women might consider selling their eggs, multiple times, to feed their children or pay the rent?”

Even the fertility industry group sponsoring the legislation acknowledges that informed consent can be problematic. A 2012 news release from the American Society for Reproductive Medicine said, 

“Prospective egg donors must assimilate a great deal of information in the informed consent process, yet it remains difficult to determine the extent of their actual understanding of egg donation and its potential risks.”

The story of the treatment of Henrietta Lacks and her descendants is a poor commentary on science and medicine. Yet it resonates with the public, which is keenly sensitive to scientific and medical abuses, even in situations that did not appear to be abuses at the time.

Stem cell research already is burdened by its own particular moral and religious baggage. With commercialization of new, pluripotent stem cell therapies coming ever closer, the last thing the field needs is contemporary version of the Lacks affair. It would behoove researchers and the stem cell industry to walk with more than normal care as they manipulate products that are tied inextricably to visions of both motherhood and money.  

Californians Top List of Stem Cell Honorees

Californians dominated the list of those to be honored at the World Stem Cell Summit coming up in San Diego this December.

They include fellow blogger Paul Knoepfler, a stem cell scientist at UC Davis, and Roman Reed, the San Francisco Bay Area stem cell activist and son of another stem cell advocate, Don Reed. Both are among the 2013 Stem Cell Action Award honorees for this year.

Others include Denny Sanford, a philanthropist whose name now adorns the Sanford-Burnham Institute in La Jolla, and Malin Burnham, who is also linked to the institute. Also being honored is Mary Ann Liebert, whose firm publishes peer-reviewed journals in science and biomedical research.

Malin is a San Diego businessman who joined with an anonymous donor in 1996 to contribute $10 million to the La Jolla Cancer Foundation. It was renamed to reflect that contribution. In 2010, Sanford pledged $50 million to the organization, and it was renamed again.

Memorial Services Friday for Duane Roth, Co-vice chairman of the California Stem Cell Agency

A memorial service for Duane Roth, co-vice chairman of the California stem cell agency, will be held Friday at 11 a.m. at Immaculata Church at the University of San Diego.

Roth died Saturday from injuries suffered in an accident last month while bicycling in the mountains east of San Diego. He was 63.

San Diego has seen an outpouring of tributes in the wake of Roth's death for his contributions to the community in the life sciences, philanthropic and technology areas. He had served on the stem cell agency board since 2006 and had been scheduled to become of chairman of the Sanford-Burnham Institute this fall. He was CEO of Connect, a non-profit organization aimed at support entrepreneurship in the technology field.

Ted Roth, Duane's brother, remembered him in a piece in the San Diego U-T as the oldest of five sons growing up in Wayland, Iowa. Ted Roth wrote that their parents relied on Duane "to set an example for his brothers, and he was the one they called upon in their later years. He was a lifelong mentor and friend to his brothers, someone that was always there to share in life’s experiences." 

Ted also wrote about his brother's involvement in technology and business.

 "Duane was captivated by the possibilities that innovation provides in improving the world in which we live." 

The family has suggested that in lieu of flowers that donations be made to the Otterson Fund at Connect, Challenged Athletes Foundation or the Copley-Price Family YMCA.

Here are links to some of the other recent articles on Roth: San Diego U-T (see here and here), La Jolla Patch, La Jolla Light.

CIRM's Roth Dies Following Bike Accident

Duane Roth, co-vice chairman of the California stem cell agency, died yesterday from brain injuries suffered in a bicycle accident two weeks ago.

Duane Roth, Connect photo

Roth, CEO of Connect, a San Diego organization aimed at fostering technology entrepreneurship, succumbed yesterday afternoon at the UC San Diego Medical Center, the San Diego U-T reported. He was 63.

An avid bicyclist, Roth was injured while biking in the mountains east of San Diego July 21. Roth hit an outcropping and his helmet was broken in the accident.

Roth was a long-time member of the 29-person governing board of the $3 billion California stem cell agency and was a strong advocate for industry. He chaired the agency's loan task force, was vice chair of the Intellectual Property and Industry Engagement Subcommittee and a member of the executive committee.

J.T. Thomas, chairman of the stem cell agency, released the following statement this morning.

“On behalf of all the CIRM family, we mourn the loss of our colleague and dear friend Duane Roth.  Throughout his tenure with us, he was one of the true stewards of the mission, offering countless insights on the role of industry in the world of regenerative medicine and how best and efficiently to drive therapies through to patients.  He was unfailingly a voice of reason and optimism and always sought to find ways to make things happen, refusing to take 'no' for an answer.  Though one of 29 Board members, his extensive participation as co-Vice Chair of the Board, co-chair of Intellectual Property and Industry Engagement Subcommittee and a member of our Executive Committee gave Duane a singularly important and resonant voice in our organization.  His passing will be deeply felt by all of us as well as by the many patients and other CIRM stakeholders whom he touched over the years.  We send our deepest sympathies to Renee, Duane's brothers and the rest of the Roth family.”

Roth recently was involved in raising funds for cancer, and reporter Bradley Fikes wrote in the San Diego U-T,

“Contributions in Roth’s name can be made to Pedal the Cause, a fund-raiser for cancer research that Roth supported. More than $10,000 has been raised since Roth's accident."

Pay-for-Eggs Legislation: A Comment on Risk

The author of the Forbes piece cited in the eggs legislation item today has responded to a comment filed by two persons opposed to the measure that would remove the ban in California on paying women for their eggs for scientific research.

Here is the text filed by Jon Entine, executive director of the Genetic Literacy Project.

“Diane and Nancy, I'm shocked that you are either unaware or do not acknowledge that there are studies of oocyte retrieval surgeries that show very persuasively that the potential harm from this procedure is manageable. While you refer to 'stories' of women being harmed--that's called anecdotal evidence and is the antithesis of science--you ignore the established research in this area, which makes it clear that you are reacting hysterically rather than responding to empirical evidence. I would suggest that you read the National Academies Press workshop report: Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (http://www.nap.edu/catalog.php?record_id=11832). It cites numerous studies, including a German study that examined the outcome of approximately 380,000 oocyte retrieval surgeries during 2000-2004. For the procedures for which there was information, the rate of complications was very low: only 0.002 percent—2 in every 100,000—had complications that required surgery to correct.

“Studies have also examined the potential risks of retrieval for a woman's future fertility.
“According to one large study, the rate of infection after oocyte retrieval was about 1 in every 200 IVF cycles, and surgery is needed to treat pelvic abscesses in less than 1 in 1,000 IVF cycles. 

“About five hundred egg donations take place in Canada each year, according to the Canadian Fertility and Andrology Society.The CFAS told me that, between 2001 and 2010, only two donors in Canada, out of a total of 4,177 donations, suffered from “severe” OHSS, which usually involves hospitalization. Fourteen others had “moderate” OHSS. These numbers are collected in a database called the Canadian Assisted Reproductive Technologies Registry.

“So sure, you can find your 'stories' but they do not represent a scientific review of the available data--you are trying to legislate based on fear. That's not science; that's the dark ages, and it's exactly the tactics used by anti-abortionists (and indeed by organizations like the Center for Genetics and Society which opposes such beneficial advances as mitochondrial replacement surgery).

“Furthermore, because women have a set of two ovaries and two fallopian tubes, they can remain fertile even if one set is damaged, and there is no evidence that both might be threatened simultaneously by the side effects of retrieval surgery. 

“Today doctors have had two decades of experience with the use of hormone treatments to maximize the number of eggs that can be harvested from a woman, and they have become quite proficient in the production of oocytes. During that time they have also worked to improve the safety of the procedure and decrease the potential risks. Despite these improvements some risk will remain, because hormones have a powerful effect on the body—they could not increase egg production so dramatically if this were not true—and anything with a powerful effect on the body has the potential for harmful side effects as well. 

“Egg donations are done for a reason. There are risks and benefits. For you to exaggerate the risks based on 'stories' and ignore the evidence is unconscionable. It's exactly what anti-abortion groups do and what opponents of genetically modified foods do--you promote fear around manageable (or in the case of GMOs, negligible) risk. 

“Your call for 'further studies' is the age old technique of reactionaries trying to control other people and impose their values on other people. You know darned well, because of your fundamental ideological opposition to this procedure, no study results could ever meet your standard of acceptability. 

“You are trying to control other women's bodies, claiming you have superior knowledge and wisdom--those are pro-life talking points. Your views, and that of the organizations that you represent, are illiberal.”

Comment re Pay-for-Eggs Item and Forbes Article

One of the authors of an op-ed piece in The Sacramento Bee has filed a comment in connection with an item today on the California Stem Cell Report. The item dealt with the California pay-for-eggs bill, which was also the subject of an op-ed piece in The Sacramento Bee as well as an article yesterday on the Forbes magazine website that discussed the op-ed piece critically.

A quotation from the article was contained in this item earlier today.

Here is the text of the comment from Nancy Scheper-Hughes, a professor of anthropology at UC Berkeley and director of Organs Watch.  Diane Tober, associate executive director of the Center for Genetics and Society of Berkeley, was the other author.

“Dr. Diane Tober and Prof. Nancy Scheper-Hughes  are 'pro choice'  social scientists who are concerned about the absence of any evidence-based medicine on the long term effects of hyper-stimulation for oocyte (egg) production in young women research subjects. We are not concerned about abortion, right to life, or obstructing  needed and valuable research on stem cells. We are concerned about the safety for potential research subjects who are being actively recruited to participate in  invasive medical procedures without any medical research studies on the possible risks and consequences of egg multiplication and extraction. We are on record that we  fully support stem cell research but not at the expense of unprotected egg donors.”  

Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown

California's pay-for-eggs bill is now officially on Gov. Jerry Brown's desk, awaiting his signature or veto.

The measure, AB926 by Assemblywoman Susan Bonilla, D-Concord, was sent to the governor at 4:45 p.m. PDT yesterday. On July 1, it easily won legislative approval and has been held in legislative processing since then. The governor has 12 days to act on the measure or it becomes law without his signature.

The legislation would remove the state ban on payment to women for their eggs for scientific purposes. Currently women who provide their eggs for fertility purposes can be compensated. Fees run as high as $50,000 in some cases, depending on the characteristics of the woman providing the eggs, but generally are in the $10,000 range or less. The bill does not affect the ban on the use of funds from the California stem cell agency to compensate egg providers.

Bonilla's bill is sponsored by the $5 billion-a-year fertility industry, which is backing it on motherhood and sexual equity grounds. Supporters say women should receive payment for their eggs just as men are paid for their sperm. They also argue that more eggs are needed for research into fertility problems. In the stem cell field, scientists have also said it is nearly impossible to find women who will provide eggs unless they are paid.

Opponents contend that the process of stimulating production of eggs can be risky or dangerous. They say that the longterm effects of the process have not been studied well. They also argue that it will lead to exploitation of low income and minority women to produce eggs that then can become a profitable commodity for the largely unregulated fertility industry. (For more informationon on the bill, see here, here and here.)

In one op-ed piece in The Sacramento Bee, opponents cited the late philosopher Ivan Illich, who was much admired by Jerry Brown, who considered him a friend. Illich was quoted as warning "against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"

The industry group says, however, that Brown is committed to signing the bill.

The measure surfaced in the news yesterday in an article on the Forbes magazine website by Jon Entine. He wrote,

“Should activist groups, working through legislators, exercise their control over women’s reproduction? Do we really 'own' our own bodies? Or does that tenet only hold when nanny groups say it’s okay?”

(One of the authors of The Sacramento Bee op-ed piece criticized in the Forbes article later filed a comment concerning their position.)

The egg legislation may have implications for regulation of stem cell research by the state Department of Public Health(again not involving the California stem cell agency). Last month the California Stem Cell Report asked Hank Greely, a Stanford law professor and chair of the state department's Human Stem Cell Research Advisory Committee, about the measure. He replied,

“Well, if (when?) AB 926 is signed, I think our committee should meet to consider what recommendations we would make to the (the department) as a result of the bill.  Those recommendations could lead, if the committee and the department agree, to a revision of the state guidelines.  As a matter of law, a statute, particularly a subsequent statute, trumps a guideline where they are in conflict, but basically I expect we'll see what the committee thinks and what the department decides.  I don't wish to guess at the results of either process.”

Another question that was not discussed publicly during the debate on the legislation deals with whether human eggs provided with compensation would be subject to state sales tax at any stage in the process. A check of the tax code, however, makes it clear that eggs are tax free. The code states that “any human body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose." The definition of “bank” includes research facilities, and "medical purposes" includes research.

CIRM's Roth Remains Hospitalized

Duane Roth, a co-vice chairman of the $3 billion California stem cell agency, is displaying no apparent brain damage following a bicycle accident 11 days ago in the mountains east of San Diego.

Bruce Bigelow of Xconomy reported this morning,

“MRI diagnostic imaging showed no apparent brain damage, but he remains sedated, according to his brother, Ted Roth. While doctors see nothing that would prevent Duane Roth from a good recovery, told me by phone yesterday his caregivers are moving slowly to give him time to heal.”

Roth is also CEO of Connect in San Diego, a technology industry assistance organization.

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.

California Stem Cell Agency Looking for New Home in Two Years

The California stem cell agency is located south of Market Street in San
 Francisco, close to the San Francisco Giants ballpark(upper right).  Since
 the agency has been there, the area has grown from seedy to gentrified. 

Some not-so-good news surfaced today in San Francisco involving the $3 billion California stem cell agency.

The news has little to do with its science efforts but everything to do with where it is located and its overhead expenses. The agency will be forced out of its free office space – 20,000 square feet – in two years. The free space was provided under an $18 million recruitment package and is worth at least $1 million a year, according to the agency's auditors.

The bad news is that the San Francisco office-space market is sizzling hot. Google, Yahoo, Microsoft and other technology firms are scrambling for space in Baghdad-by-the-Bay, as the city is sometimes known. According to a story this morning by James Temple in the San Francisco Chronicle, the firms are looking for a total of about 800,000 square feet and are prepared to pay well for it.

One nearly completed deal involving Yahoo would cost about $48 per square foot for a 10-year lease. If CIRM paid at that rate, it would have nearly $1 million in additional costs annually. However, leasing rates are expected to rise substantially in the next year or so. Also involved in a move would be the cost of parking, which could run about $360,000 a year.

The stem cell agency is already examining its options for new offices, including some sort of special deal with the City of San Francisco.

Former State Sen. Art Torres, onetime chairman of the state Democratic Party and co-vice chairman of CIRM, briefed agency directors on the matter at its meeting in May. He said,

“I met with the mayor of San Francisco(Ed Lee), who's a dear friend, and he encouraged us to be aware that he's very committed to helping us find some space in San Francisco. Whether it means tax credits or incentives to a potential landlord, we still have to work that out. Obviously we still have to work out what the space will be. But the fact that the mayor has indicated very explicitly that he wants to keep us in San Francisco, I think it will bode well for us down the road.

“The current owner of the property (Stockbridge Capital Partners) has not been happy that for ten years they've had to supply free rent to us. And what they didn't anticipate was having to provide for over $755,000 in operating costs, which they thought some donors would take are of. Those donors -- some of whom passed away and others who chose to give money to other institutions, UC San Francisco, in particular, to the stem cell lab, which was very much appreciated, I know, by UCSF – but at the end of the day, there's no room for negotiations with this current owner.”

CIRM Director Joan Samuelson asked Torres whether future rent would also be free. Torres, who is also president of San Francisco's Public Utilities Commission, replied,

“I would not work on that assumption. I would work on the assumption somewhere between a dollar and more, again, dependent upon what kind of tax incentives the City of San Francisco would provide. We're very fortunate that my son(Joaquin Torres) is the deputy mayor for economic development, so we also have him working on this as well.”

Samuelson replied,

“I'll ask more questions offline.”

California Stem Cell Official Duane Roth in Improving Condition

Duane Roth, the co-vice chairman of the California stem cell agency, is improving after he was hospitalized for treatment of a serious brain injury sustained in a bicycle accident Sunday in the mountains east of San Diego.

According to a report on Xconomy.com, Roth's brother, Ted, said yesterday, 

“Were certainly moving in the right direction. We're now looking at the recovery phase.”

The article by Bruce Bigelow said Roth has passed through the most critical period following surgery at the UC San Diego hospital.

Roth, the 63-year-old CEO of the San Diego technology organization, Connect, is in serious condition in a medically induced coma.

The governing board of the California stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.  

Stem Cell Agency Board Concludes Meeting

The governing board of the California stem cell agency concluded its meeting today at 2:33 p.m. PDT. The California Stem Cell Report has also concluded its coverage today's session.

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.

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..

.

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.