$500,000 to Fight Covid-19 from California's Stem Cell Program

The California stem cell agency on Friday awarded a total of $500,000 to two UCLA scientists to help in the fight against Covid-19, including early stage research aimed at boosting the immune response of older persons. 

The grants are part of a $5 million, "emergency" Covid round that is aimed at fast-tracking promising research. 

Song Li (left) and Vaithilingaraja
Arumugaswami, UCLA photos

Vaithilingaraja Arumugaswami

received $350,000 for work dealing with Berzosertib, a therapy targeting viral replication and damage in lung stem cells. 

Arumugaswami said in a UCLA news release, 

"Clinical trials have shown that Berzosertib blocks the DNA repair pathway in cancer cells, but has no effects on normal, healthy cells. For this reason, we think this drug shows great promise for treating COVID-19 patients and could be rapidly and safely be deployed in the clinic."

A summary of reviewer comments on his application (TRAN1COVID19-11975) can be found here. 

Song Li received $150,000 to help develop an injectable biomaterial that can induce the formation of T memory stem cells, which are important in generating an immune response. 

Li said that if his work is successful, it could have applications well beyond Covid-19. A summary of reviewer comment on his application (DISC2COVID) can be found here. 

Directors of the agency rejected six applications in their action on Friday. Summaries of all application reviews can be found here. 

The stem cell agency, which is running out cash, is now supporting 11 Covid-19 projects, including two clinical trials. The fast-track Covid round is accepting applications every two weeks. More awards are expected when agency directors meet again on June 26. 

The agenda at that time will include other matters such as the budget for the coming 12 months, including a wind-down schedule should voters reject a $5.5 billion ballot measure to refinance the agency, which is running out of money. 

  

Click on this sentence to see the agency's press release on last week's awards. 

California's $5.5 Billion Stem Cell Countdown: Total Now up to Nearly 540,000

California county elections officials have been tallying
signatures on stem cell initiative petitions for one month.

Nearly 27,000 signatures were added today as the $5.5 billion effort to rescue the California stem cell agency moved slowly towards an all-but-assured position on the November ballot

The proposed ballot initiative is aimed at saving the agency from its financial demise. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, the California Stem Cell Report analyzed the trends in the tally, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 537,558 verified signatures of registered voters, up from yesterday's 510,930. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Look for the next update on the count Monday evening or early Tuesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: Campaign Not Likely To Sue for Deadline Extension

Solano County contributed 7,670 signatures this afternoon to the snail-like progress of a $5.5 billion stem cell research proposal towards a virtually assured position on the November ballot.

The measure is aimed at saving the California stem cell agency from fiscal extinction. The 15-year-old program is running out of cash and will begin closing its doors in the fall without more funds. 

Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 510,930 verified signatures of registered voters, up from yesterday's 503,260. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 14 counties out of 58 have not filed their verification numbers.

If the stem call initiative comes up short, it could join the effort to force the state to extend the deadline. Two groups have already sued seeking more time. One effort involves sports betting at Native American casinos. The other involves data privacy. The basic argument is that the Covid-19 crisis seriously and unexpectedly hampered the signature gathering which is constitutionally protected process. 

However, in response to a query, campaign spokeswoman  Sarah Melbostad today said,

"We have been pleased with the validity rates we’ve seen so far and are still confident that we are going to qualify for the November 2020 ballot. We have no plans to join these lawsuits or to file our own."

Look for the next update on the count tomorrow evening or early Saturday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: Inching Towards November 3

San Francisco stepped up today to provide 10,900 signatures to help the California stem cell agency refinance itself through a $5.5 billion initiative that is headed for the November ballot. 

What's at stake is qualifying the proposal so that it will be presented to voters in the fall. Earlier this week, The California Stem Cell Report analyzed the trends in the count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 503,260 verified signatures of registered voters, up from yesterday's 492,349 . The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 15 counties out of 58 have not filed their verification numbers. For stem cell history buffs, San Francisco, once known as Baghdad by The Bay, also was once known as the home of the stem cell agency for a number of years. The city won the headquarters in a bidding war after it promised $18 milion, including 10 years in free rent. The agency moved to Oakland when the free rent ran out because of the high cost of office space in San Francisco.

California Gov. Gavin Newsom was then mayor of San Francisco and played a major role in reeling in the stem cell agency. He has not spoken publicly about whether he supports the $5.5 billion initiative. 

Look for the next update on the count tomorrow evening or early Friday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

California's $5.5 Billion Stem Cell Countdown: The Official Tally Creeps Towards the Certainty of November

Watching the Signature Numbers

* The campaign is seeking 110 percent of the
legal requirement of 623,212 to avoid going to a 
prolonged full check. Sources: Secretary of State
June 9, 2020, California Stem Cell Report

The $5.5 billion initiative to save the California stem cell agency from its financial demise today made more slow progress in the official state count that is nearly certain to qualify it for the November ballot. 

The numbers already show that the measure is headed for the ballot unless something extremely unusual occurs. The California Stem Cell Report yesterday  analyzed the trends in the signature count, concluding that qualification is in the "virtual bag." 

Today's figures from state officials showed 492,349 verified signatures of registered voters, up from 484,973 on Monday. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 16 counties out of 58 have not filed their verification numbers.

Look for the next update on the count tomorrow evening or early Thursday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

Editor's note: An earlier version of this item said Monday's count of verified signatures was 481,689, which is actually from Friday. The correct figure for Monday is 484,973.

California's $5.5 Billion Stem Cell Countdown: Formal Upward Trend, Qualification Clearly Likely

A $5.5 billion initiative to refinance the California stem cell agency with $5.5 billion chalked up additional formal progress today, although it is clear that it will go before voters in November.

The numbers already show that the measure is virtually certain to make the ballot unless something extremely unusual occurs. The California Stem Cell Report earlier today analyzed the trends in the signature count, concluding that qualification is in the "virtual bag." The analysis also appeared on Capitol Weekly, an online California government and politics news service.

Today's figures from state officials showed 484,973 verified signatures of registered voters, up from 481,689 on Friday. The campaign is hoping for 685,534. The qualification rate is steady at about 78 percent. If the qualification rate stays fractionally above 67 percent, the measure will be placed on the ballot.  

Only 17 counties out of 58 have not filed their verification numbers.

Look for the next update on the count tomorrow evening or early Wednesday on the California Stem Cell Report, your only independent source of information and news about the stem cell agency for the last 15 years.

(Editor's note: An earlier version said that 16 counties have not filed their verification numbers. The correct figure is 17.)

California's $5.5 Billion Stem Cell Countdown: Ballot Qualification in Virtual Bag

California Stem Cell Initiative:

Current Shortfall for Ballot Qualification

Total Raw Signatures	924,189
Total Outstanding Unverified	305,312
Total Needed Under Quickest Way to Qualify	685,534
Total  Verified	481,689
Current Shortfall	203,845

Source: California Secretary of State 6/5/2020/California Stem Cell Report

The $5.5 billion California stem cell initiative is virtually certain to qualify for the fall ballot as the arithmetic of the signature count begins to fall into place.

The measure needs only slightly more than the 67 percent of the signatures that remain to be verified as coming from registered voters. The qualification percentage of raw signatures so far is 78 percent.

It is unlikely that that the qualification rate for the remaining raw signatures would drop as low as 66 per percent unless something quite unusual occurs. Only 18 of the 58 counties have yet to verify their raw signatures, which total 305,312. The initiative needs 203,845 verified signatures to make the ballot.

The ballot initiative is aimed at saving the California stem cell agency from financial extinction. Known formally as the California Institute for Regenerative Medicine (CIRM), the agency has nearly run through the $3 billion it received from voters in 2004. Without a major cash infusion, it will begin closing its doors next fall.

The campaign is shooting for the quickest way to the ballot. It submitted 924,189 raw signatures about one month ago. Legally, the measure needs only 623,212 signatures that are verified to have come from registered voters.

However, the state permits a combination of a random and hand count total of 110 percent of that number to qualify a measure without going to a signature-by-signature verification. County election officials are currently in the combination, random sample phase of checking the signatures on the ballot initiative petition.

If the current process falls short of 110 percent, the state requires a "full check" of each signature, a task that likely cannot be completed by the state's deadline of June 25. Counties have until June 24 to report to the state. (If the percentage falls below 95, the measure will not qualify.)

See here for the state's official report on the count as of the end of work last Friday. Here are more details on how the initiative process works in California.

The California Stem Cell Report will have updated figures this evening or early tomorrow.

California Stem Cell Ballot Initiative Signature Count

Unverified/raw signatures outstanding as of June 5, 2020

County	Raw Signatures
Alameda	31,002
Butte	6,502
Contra Costa	23,167
Fresno	29,072
Inyo	610
Kings	1,756
Lake	2,088
Placer	8,343
Riverside	51,478
San Benito	485
San Diego	99,899
San Francisco	14,263
San Mateo	6,491
Santa Cruz	6,436
Solano	9,910
Trinity	142
Tulare	9,663
Yolo	4,005
Total Outstanding Unverified	305,312

Source: California Secretary of State 6/5/2020, California Stem Cell Report
(Editor's note: An earlier version of this chart listed San Joaquin in place of San Francisco.)

California's $5.5 Billion Stem Cell Countdown: 70 Percent on the Way to Making the Ballot

State election officials yesterday reported that the $5.5 billion, California stem cell initiative is 70 percent on its way to qualifying for the November ballot. 

The latest number of valid signatures totalled 481,689. The measure's backers hope that they will have 685,534 valid signatures of registered voters out of 924,189 unverified signatures they submitted nearly a month ago.

The qualification rate still stands at about 78 percent.

The proposal would save the financial life of the California stem cell agency, which is running out of money. It was provided with $3 billion by California voers who created in in 2004. It will begin shutting down this fall without substantial financial assistance.

Reporting in yesterday was Orange County. Among the larger counties not yet reporting are San Diego and Riverside.

Look for an update on the tally Monday evening or early Tuesday morning right here on the California Stem Cell Report, your source for the last 15 years for all things dealing with the stem cell agency, officially known as California Institute for Regenerative Medicine(CIRM). 

California's $5.5 Billion Stem Cell Countdown: Sixty Percent on the Way to the Ballot

The $5.5 billion, California stem cell initiative this afternoon climbed closer to qualifying for the ballot but still remains more 200,000 signatures away from going before voters in the fall. 

The measure is an effort to financially rescue the California stem cell agency, which is running out of money. It will begin shutting down this fall without substantial financial assistance. 

Today's report from state election officials showed 411,839 verified signatures out of a raw total of 924,189.  Backers of the measure are hoping for 685,534 valid signatures to avoid going to a "full check," signature-by-signature count. Such an effort in 58 counties could be so prolonged that the measure would miss the deadline for being placed on the ballot. 

The current count is a combination of a hand count and random sampling. 

State election officials have set a deadline of June 24 for counties to submit figures. The state's own deadline to complete its work is June 25.

Today's tally is 60 percent of the needed 685,534. It is 110 percent of the legally required figure of 623,212.

So far about 78 percent of the raw signatures have been verified as coming from legally registered voters. 

Still missing from the total of verified signatures are San Diego, Riverside and Orange counties, which have a total of 200,546 raw signatures. 

Look for an update on the tally tomorrow evening or early Saturday morning right here on the California Stem Cell Report, your source for the last 15 years for all things dealing with the stem cell agency, officially known as California Institute for Regenerative Medicine(CIRM). 

California's $5.5 Billion Stem Cell Countdown: Two Pathways to the Ballot But Maybe One Not So Good

A $5.5 billion, proposed ballot measure today is anywhere from 58 percent to 63 percent on its way to possibly saving the California stem cell agency from financial extinction.

The agency, known formally as the California Institute for Regenerative Medicine (CIRM), is running out of  money -- the $3 billion that voters gave it in 2004. It needs the initiative to qualify for the ballot and voters to approve it or CIRM will begin closing its doors next fall. 

As of this evening, the multibillion dollar rescue proposal was nominally 63 percent along the road to qualifying. The measure had 394,237 valid signatures of registered voters, according to election officials. It needs 623,212. 

But the campaign says it really wants substantially more. A campaign official today said that its desired figure is 685,534, 110 percent of 623,212. Reaching 110 percent would avoid a "full check," which is a prolonged verification of each signature. That process might not be finished until after the deadline of June 24 for counties to get their figures to state election officials. The state schedules its verification on June 25.

A goal of reaching 685,534, however, means that the backers of the measure have only 58 percent of the signatures needed.

"If the result of the (now ongoing) random sample indicates that the number of valid signatures represents between 95% and 110% of the required number of signatures to qualify the initiative or referendum measure for the ballot, the secretary of state directs the county elections officials to verify every signature on the petition,"  according to the state's ballot initiative web site. 

"For an initiative measure, if the number of valid signatures is greater than 110 percent of the required number of signatures, the initiative measure will be eligible for the ballot," the state says. 

Critical to the process is the percentage of qualified signatures out of the 924,189 that were turned in May 12 by the measure's backers. That percentage is holding relatively steady at about 78 and has varied little as the count has progressed over several weeks. As long as validity rate stays above about 74 percent, the initiative will be sent to voters. 

"We’ve been very pleased with the validity rate so far and believe we have more than enough valid signatures to qualify," said Sarah Melbostad, a campaign spokeswoman.

The measure's validity rate is also closely aligned with five other initiatives that have qualified or nearly qualified in recent months for the fall ballot. Those initiatives have run or are running at rates that range from 73 percent to 78 percent. That is significant because the signatures are largely gathered by firms that specialize in that sort of work. 

It is reasonable to surmise that the firms, which compete for business, are more than likely to produce similar results. (For the other initiatives, see here and also here. The five initiatives mentioned had to labor under the restrictions of the Covid crisis.)

Officials have not yet verified signatures in some larger counties including San Diego, Orange and Riverside.  

Look for the latest figures tomorrow evening or early Friday on the California Stem Cell Report.

Advisory: Update on Ballot Count for California Stem Cell Measure

The state elections office reported this afternoon that later today it will post fresh figures on the qualification count for the $5.5 billion stem cell measure. A spokesman for the office said that it has not received any fresh figures from the counties since Monday afternoon. The California Stem Cell Report will carry an item on the latest figures when they come in.

Advisory on Ballot Initiative Count, Fresh Figures Not Forthcoming

State election officials have not posted a fresh count of signatures on the $5.5 billion stem cell proposal since Monday evening. We are inquiring about the matter and will post what we learn when we learn it.

California's $5.5 Billion Stem Cell Countdown: Sixty-two Percent Along the Road to the November Ballot

Backers of California's $5.5 billion stem cell research measure this afternoon received a hefty boost as their effort to place the proposal on the November ballot moved dramatically forward. 

The initiative is now 62 percent along the path to reaching voters. That figure emerged when Los Angeles County reported that it has counted 231,196 valid signatures of registered voters. The total number of valid signatures now stands 381,849. To be placed on the ballot requires 623,212. 

The percentage of valid signatures at 78 percent. If that qualification rate holds up, the proposal will be on the ballot since the campaign has submitted 924,189 "raw" signatures. Still outstanding are large counties such San Diego, Riverside and Orange.

The measure is aimed at saving the financial life of California's stem cell agency, which has nearly run through the $3 billion that voters provided it in 2004. With no infusion of additional funds, it will begin closing its doors next fall. 

Look for an updated count tomorrow evening or early Wednesday morning right here on the California Stem Cell Report. 

California's $5.5 Billion Stem Cell Countdown: Snail-like Progress Towards the Ballot

The final steps to qualify a $5.5 billion stem cell measure for the California ballot in November moved slowly this past week with the latest figures rising only marginally. 

State officials reported late yesterday that the number of valid signatures stood at 150,598, up slightly from 146,611 the previous day. 

In order to save the California stem cell agency from financial extinction, the initiative needs 623,212 valid signatures of registered voters.  Backers submitted 924,183 "raw" signatures.  

The signature disqualification rate yesterday stood at 22 percent, which is where it has been since May 22.

Large counties such as Los Angeles and San Diego have not yet reported on their verification efforts. The state deadline for counties to report their figures to the state is June 24. 

The stem cell agency is running out of cash and will begin closing its doors next fall unless it receives a substantial infusion of cash.

Look for an updated count Monday evening or early Tuesday morning right here on the California Stem Cell Report. 

California's Stem Cell Agency Backs More Covid Research in its $5 Million Round

The California stem cell agency this afternoon awarded a total of $450,000 to three researchers to fight Covid-19, which has infected nearly 91,000 persons in the Golden State and nearly 1.8 million nationally.

The action brought to nine the number of awards made in the agency's $5 million Covid round, which now has about $2.5 million remaining. 

Today's awards involved basic research, including a project aimed at a vaccine. Maria Millan, CEO of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), said in a news release. 

"“These three projects highlight three very different approaches to combatting the acute devastating health manifestations of Covid-19 as well as the debilitating sequelae that impact the ability to recover from the acute illness. Through this Covid funding opportunity, CIRM is enabling researchers to re-direct work they have already done, often with CIRM support, to quickly develop new approaches to Covid-19."

The vaccine research award (application number DISC2COVID19- 11941) went to Albert Wong of Stanford. The $149,000 grant will be used to develop a cellular response to beef up immunity. A CIRM news release said Wong's "team will use the experience it gained using CIRM funds ($3 million) to (fight) glioblastoma, a deadly brain cancer, to advance a similar approach to produce an effective cellular immune response to combat Covid-19."

CIRM directors directed Wong to apply for a supplement of up to $100,000 to cover more work to assure that his work has application to under-served and under-researched communities that have been the most seriously affected by Covid.

Another Stanford scientist, Helen Blau, was awarded $149,996 (DISC2COVID19-11920) to help prevent atrophy of the diaphragms in Covid patients on mechanical ventilation. 

Jianhua Yu of the City of Hope was awarded $150,000 (DISC2COVID19-11947) for research to turn umbical cord blood cells into natural killer cells that would target Covid. The research would leverage existing studies that the City of Hope has developed to treat cancer. 

Summaries of the reviews of their applications and scores can be found here. That web page also includes summaries of the review of the 10 applications that were rejected. 

CIRM directors are expected to meet again within the next couple of weeks to fund more Covid research under its fast-track effort to combat the disease. The agency was created 15 years ago with $3 billion in state funding, but it is running out of money and will begin closing its doors this fall unless more funds are forthcoming. 

An American Vaccine Disaster 65 Years Ago: Lessons for Today

"Remember the Cutter Incident!" The phrase is not exactly the same sort of watch word as "Remember the Alamo." 

But it does have fresh resonance today. The Cutter Incident was a vaccine disaster in America 65 years ago. The case is the keystone of a column yesterday in the Los Angeles Times that said, "History tells us that speed kills."

The comment came from Arthur Caplan, a bioethicist at NYU Langone Medical Center and a co-author of an article this week in the Journal of the American Medical Association (JAMA) that sounded a warning in the rush for a Covid-19 vaccine. 

Caplan spoke about the matter with Michael Hiltzik, a business columnist at the Times and author of "Big Science." Hiltzik's column appeared one day before the California stem cell agency is set this afternoon to consider more applications in its $5 million Covid-19 funding round. (Vaccines also came up at last Friday's meeting of the agency's governing board.)

Hiltzik wrote, 

"If anything is known for sure about the scientific battle against the novel coronavirus, it’s that the quest for a vaccine has been unprecedentedly intense, with rapid development and speedy production the paramount goals."

The Cutter Incident, Hiltzik said, is example of the perils of speed. It involved errors in a polio vaccine produced in 1955 by Cutter Laboratories. An estimated 40,000 children contracted polio from the vaccine. About 200 were permanently paralyzed. Ten died. 

Hiltzik wrote, 

"The so-called Cutter incident was 'one of the worst biological disasters in American history, exploded the myth of the invulnerability of science and destroyed faith in the vaccine enterprise,' observed Paul Offit, a vaccine expert at the University of Pennsylvania whose 2005 book is the definitive account of the episode."

The polio vaccine was halted in its tracks during the summer of 1955. Hiltzik wrote, 

"Public confidence in the vaccine was shattered. 'The summer of 1955 came and went with few children getting their shots,' historian David Oshinsky, a co-author of the JAMA article, recounted in his 2005 history of the epidemic. Major outbreaks occurred in Boston and Chicago. 'It seemed like old times, with beaches and movie theaters once again deserted and people fleeing the cities to escape the evil germs.'"

Hiltzik concluded, 

"Clinical trials won’t be the final hurdle in bringing vaccines to the world. Managing the public’s expectations will be crucial, since no vaccine for anything is 100% effective. So will ensuring that the manufacturing process is airtight.

"With anti-vaxxers and conspiracy theorists already spreading wild stories about the coronavirus, it would be a shame to give them more ammunition.

"'In this world, where there’s so much vaccine hesitancy and doubt,' Caplan said, 'you better get it right, out of the box. You can’t afford a failure. Even knowing that we’re in desperate need of a vaccine and the deaths are happening, I worry that if we don’t do it right, it’s going to be worse.'"

California's $5.5 Billion Stem Cell Countdown: Still Creeping Up Little by Little

The drive to save the California stem cell agency with a $5.5 billion bond measure gathered modest momentum today in the signature count to put the proposal on the November ballot. 

The total number of valid or projected valid signatures late this afternoon advanced to 146,611, up slightly from 98,159 yesterday. The ballot initiative needs 623,212 valid signatures. Backers submitted 924,183 "raw" signatures.  

The signature disqualification rate stood at 21 percent, about the same as yesterday's 22 percent.

Large counties such as Los Angeles and San Diego have not yet reported on their verification efforts. The state deadline for counties to report their figures to the state is June 24 -- 20 business days away. 

The stem cell agency is running out of cash and will begin closing its doors next fall unless it receives a substantial infusion of cash.

Look for an updated count tomorrow evening or early Saturday morning right here on the California Stem Cell Report. 

Rogue Stem Cell Clinics and Covid: California Moves 'Sedately' on Regulation

The state of California and its top medical regulator remain mired in a go-slow posture on regulation of "snake oil" stem cell clinics that are currently riding the Covid crisis to peddle dubious treatments to desperate patients.

The marketing surge by the clinics has drawn increased attention nationally, including in prestigious scientific journals such as Cell Stem Cell whose usual fare deals with such things as "Stem Cell Hierarchy in Colorectal Cancer."

But one article published earlier this month was titled:

 "Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed 'Stem Cell Treatments' for COVID-19." 

The quotes around "stem cell treatments" are deliberate. No guarantee exists that the treatments actually include stem cells. 

Leigh Turner, an associate professor of bioethics at the University of Minnesota, authored the piece. He said,

"In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for Covid-19. 

"Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for Covid-19."

Nearly two years ago, California's State Medical Board said it was going to tackle the problem of the rogue clinics. But to this date little has occurred. State legislation to develop regulations was also sidelined.

The California Stem Cell Report queried the medical board earlier this month concerning the status of its effort and whether regulations had been drafted and when a draft would be ready. In response, the board last week released the following statement:

"The board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow that will include a sample informed consent document and educational materials for the public to present to the board for review and final approval. 

"In the meantime, pursuant to Business and Professions Code section 684, healthcare practitioners providing stem cell therapy not approved by the Food and Drug Administration (FDA) and who have not obtained approval or clearance for an investigational new drug or device exemption from the FDA for the use of human cells, tissues, or cellular or tissue-based products, must provide notice to their patients indicating the lack of FDA approval, and encouraging their patients to consult with their primary care physician before treatment. Individuals concerned about a physician’s stem cell practice should file a complaint with the Board for review and appropriate action."

The issues with the clinics has drawn attention in the Los Angeles Times from Pulitzer Prize winning columnist Michael Hiltzik  who wrote recently,

"The proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The Covid-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims."

The California stem cell agency has also pushed for tighter regulation and partnered to help pass the law for disclosure notices concerning lack of FDA approval. For patients considering stem cell treatments, the agency has posted as rundown on issues concerning the treatments or clinical trials. 

(After this item was posted, the agency posted a blog item dealing with Parkinson's. In addition to information on the search for a cure or treatment, the item carried the following advice for persons seeking some sort of unregulated treatment. Here is what the agency had to say in a Q&A format,

"If you go online you can find lots of stem cells clinics, all over the US, that claim they can use stem cells to help people with Parkinson’s. Should I go to them?

("In a word, no! These clinics offer a wide variety of therapies using different kinds of cells or tissues (including the patient’s own blood or fat cells) but they have one thing in common; none of these therapies have been tested in a clinical trial to show they are even safe, let alone effective. These clinics also charge thousands, sometimes tens of thousands of dollars these therapies, and because it’s not covered by insurance this all comes out of the patient’s pocket.

("These predatory clinics are peddling hope, but are unable to back it up with any proof it will work. They frequently have slick, well-designed websites, and  'testimonials' from satisfied customers. But if they really had a treatment for Parkinson’s they wouldn’t be running clinics out of shopping malls, they’d be operating huge medical centers because the worldwide need for an effective therapy is so great.

("Here’s a link to the page on our website that can help you decide if a clinical trial or “therapy” is right for you.")