Stem Cell Clinic

Is Human Embryonic Stem Cell Research in Jeopardy? – Healthline – Healthline

Studies on diseases like ALS, Alzheimer's, Parkinson's, and Huntington's jeopardized if GOP-controlled Congress cuts funding for embryonic stem cell research.

In 2010, when renowned stem cell scientist Lawrence Goldstein, PhD, published his groundbreaking book Stem Cells for Dummies, with co-author Meg Schneider, the forecast for human embryonic stem cell research had just begun to brighten.

In 2001, former President George W. Bush cast a cloud over this field of science by barring the National Institutes of Health (NIH) from funding research that used embryonic stem cells beyond the 60 cell lines that already existed.

But in 2009, then-President Barack Obama signed an executive order repealing Bushs policy.

Obamas decision enabled researchers like Goldstein, director of the UC San Diego Stem Cell Program, and Sanford Stem Cell Clinical Center, to make real progress, inching closer to human clinical trials.

Goldsteins work focuses on discovering clinical applications for human embryonic stem cells, also known as ESC.

His work looks specifically at clinical applications for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), and Alzheimers, Parkinsons, and Huntingtons diseases.

After 10 years, weve seen a variety of projects that use embryonic stem cells moving closer to clinical applications and in clinical trials, Goldstein told Healthline.

Although its taken some time, were getting closer to seeing the most promising approach for treatment of different neurologic disorders that have no suitable treatment alternative.

Read more: Stem cells therapy offers hope for MS remission

But now use of human embryonic stem cells are once again under fire from conservative and pro-life groups.

Contrary to popular belief, human embryonic stem cells do not come from aborted fetuses.

All the human embryonic stem cell lines currently in use are derived from unused embryos developed for in vitro fertilization and donated for research.

They are cells that would have only been discarded.

Nevertheless, their use in research is opposed by many in the pro-life movement, including a vocal coalition in Congress.

Last month, 41 conservatives in the House urged President Trump to fire Dr. Francis Collins, director of the NIH, the worlds largest agency funding biomedical research, because Collins supports embryonic stem cell research.

However, Trump announced last week he was reappointing Collins, a widely respected physician-geneticist.

Several Republican leaders in Congress had reportedly urged Trump to retain him, calling Collins the right person, at the right time, to continue to lead the worlds premiere biomedical research agency.

But Trumps decision didnt sit well with many in his voting base and his own cabinet.

Vice President Mike Pence, and Health and Human Services Secretary, Tom Price, have both spoken out against the use of embryonic stem cells on moral grounds.

Just a few weeks ago, Pence got a standing ovation at the National Catholic Prayer Breakfast when he reminded the audience that he was the one who cast the tie-breaking vote in the United States Senate that allowed states to defund Planned Parenthood.

The Congressional conservatives who called on Trump to fire Collins are voicing their anger over Trumps decision to retain Collins.

Rep. Jim Banks, R-Ind., told LifeNews, a pro-life publication, that he was disappointed in the Trump Administrations decision.

Dr. Collins support of embryonic stem cell research, along with his comments that cloned embryos do not deserve the same moral protections as naturally generated embryos, make him a less than an ideal fit for a pro-life administration, Banks said. I am hopeful that Dr. Collins will turn away from embryo-killing research as he continues his tenure as NIH director.

Trumps election has resulted in a new and unprecedentedly tenuous era for the NIH. Its funding has typically had bipartisan support.

Despite Trumps seemingly pro-science pivot, the NIH still faces a potential $5.8 billion cut about 18 prevent in the presidents fiscal 2018 budget.

And this plank from the 2016 GOP platform remains in place:

We oppose embryonic stem cell research. We oppose federal funding of embryonic stem cell research. We support adult stem cell research and urge the restoration of the national placental stem cell bank created by President George H.W. Bush but abolished by his Democratic successor, President Bill Clinton.

Goldstein and several other scientists interviewed for this story said that while Trumps decision to retain Collins is a positive, theres still no guarantee that embryonic stem cell research will continue getting support from the federal government in this increasingly hostile and volatile political climate.

While human embryonic stem cells are just one of several types of stem cells being studied for their innate, but complex, abilities to treat diseases, Goldstein explained, they are an important weapon in a growing arsenal.

It takes a great deal of time, money, and patience to develop these therapies, he noted.

It would be a shame to go back to the dark age solution that we had under the Bush administration, said Goldstein, who is currently focused largely on ALS, also known as Lou Gehrigs disease, named for the legendary New York Yankee.

Gehrig died from the disease at age 37.

Goldstein said a lot of individuals and institutions are working to find treatments for ALS, which has enjoyed a boost in awareness and funding thanks to the recent Ice Bucket Challenge that caught on nationwide.

Its important that we develop an aggressive set of cell therapy programs so that we have multiple shots on goal, Goldstein said. We need to attack the disease from as many angles as possible.

Read more: Stem cell therapy a possible treatment for RA

For the last 25 years, Frances Saldaa has been on a mission to increase awareness of Huntingtons disease (HD), a debilitating, incurable, and often inherited disease.

Its become my mission in life to advocate for support of HD research and for excellence in patient care, said Saldaa, whose husband, Hector Portillo, didnt tell her he had the disease.

Three of their children inherited HD from their father. Both of Saldaas daughters have died, and her son is not doing well.

My son Michael is fighting for his life every single day, but time is running out for him too, she said. The suffering endured at the end of life for HD patients is unimaginable. My daughter, Margie, and her husband did not have the money to go through IVF when they started their family. They had two beautiful children. I live in fear that my two grandchildren, now 19 and 21, are also at risk of inheriting HD.

When Saldaa learned that members of Congress were urging President Trump to fire Collins, her heart sank.

To have the door close on this research because they have this belief would be tragic, she said. In my opinion, an embryonic egg is not life until its attached to the placenta.

Saldaa said that if she had the opportunity, she would ask people who oppose this research, Have they ever seen their own children dying devastating deaths? Have they ever seen their own children lose the ability to talk, to swallow? Have they ever had their own child die in their arms, and yet know that there is hope, that there is a chance with this research to find a cure?

Ive dedicated my life to supporting this research, from Team Hope walks to bake sales, everything and anything to find a cure, she said.

Leslie Thompson, PhD, a professor of psychiatry and human behavior, and professor of neurobiology and behavior, at the University of California Irvine, has devoted her entire career to unlocking the mysteries of Huntingtons disease and finding treatments.

Thompson, who said many of her patients with HD are like family, said human embryonic stem cells present great hope for finding a treatment for HD.

And after decades of painstaking study, she told Healthline that her work could lead to human clinical trials for people with HD as soon as two or three years from now.

Thompson keeps a picture of Saldaas children in her office to remind her of what her research is really all about.

Im deeply concerned how this could move the field backwards, she said, but added that she is hopeful her work and that of others will be allowed to continue.

Were in an exciting, unprecedented time of opportunity to use stem cells for treatments, she said.

When former President George W. Bush decided to halt new human embryonic stem cell research, Saldaa recalled, We all jumped and went toward getting Prop 71 passed.

The California Stem Cell Research and Cures Initiative, which was passed by a 60-40 margin, was drafted by the California Institute for Regenerative Medicine. It has provided millions of dollars in stem cell research in the state, including embryonic stem cell research.

The public vote on this initiative has helped California become the national leader in stem cell research.

There is also solidarity in the stem cell community. Even scientists who dont use human embryonic stem cells still support their colleagues who do.

Jeanne Loring, PhD, a professor of developmental neurobiology, and director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, Calif., made the shift about a decade ago from human embryonic stem cells to induced pluripotent stem cells (IPS), which she makes from cells cultured from skin biopsies.

There are certain advantages to IPS, she said, but added that she still fully supports embryonic stem cell research.

Its hard to predict what President Trump will do, said Loring, whose lab is working on finding treatments for Parkinsons disease, discovering the cause of autism, ways to treat it, and more.

Loring notes that there are great misunderstandings about embryonic stem cell research and where the cells come from.

There is always an undercurrent of misunderstanding about sources of human stem cells. People think they are associated with abortion but they are not. she said.

Read more: Using stem cells to heal broken bones

What lies ahead for human embryonic stem cell research is anyones guess.

When Obama signed the order to lift Bushs ban on new embryonic stem cell research, he said, In recent years, when it comes to stem cell research, rather than furthering discovery, our government has forced what I believe is a false choice between sound science and moral values.

In this case, I believe the two are not inconsistent. As a person of faith, I believe we are called to care for each other and work to ease human suffering. I believe we have been given the capacity and will to pursue this research and the humanity and conscience to do so responsibly.

Goldstein said he hopes Trump, too, will embrace the importance of this research that seeks to find treatments for deadly diseases.

Its early in this administration, there is still time for them to staff up with people who will give the President the appropriate scientific advice, Goldstein said. There are many challenges facing us that are technological in nature. You cant have a humming economy without robust investment in science. It drives the development of new technologies and devices. An investment in science pays far more than what you put in.

Goldstein said investing heavily in science has helped give the United States the quality of life that Americans now enjoy.

Our investments in science and technology are likely the reason for winning World War II, he said. And our investment in biotech has revolutionized medicine and has been invaluable to providing jobs in many states.

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Is Human Embryonic Stem Cell Research in Jeopardy? - Healthline - Healthline

Stem cell scientist to become the latest Democrat trying to topple Dana Rohrabacher in OC House race – Los Angeles Times

An internationally known stem cell scientist and entrepreneur will join the ranks of candidates trying to unseat Republican incumbents in contested House races next year when he announces Thursday his challenge of 18-term Rep. Dana Rohrabacher.

Hans Keirstead, a 50-year-old Democrat from Laguna Beach, said Wednesday that he will run in the 48th Congressional District, one of more than half a dozen in California that have been targeted by Democrats seeking to harness sentiment against President Trump in their fight for a House majority.

Keirsteads candidacy has been sought by some national Democratic figures, who see his science and business background as a good fit for the district. It runs along the Orange County coastline from Laguna Beach to Seal Beach, and includes some nearby inland cities.

Republicans represent a plurality of the district with more than 40% of its registration, to about 30% for Democrats. A quarter of voters are registered as nonpartisan. The Huntington Beach-based Rohrabacher, who is 69, has served in the House since 1988.

Part of the reason for the Democratic drought in the 48th and other districts now seen as competitive has been the partys candidates; Rohrabacher last faced a serious challenge in 2008, when he won by 10 percentage points. In November, he won by more than 16 points. Hillary Clinton won the district by almost 2 points en route to becoming the first Democratic presidential nominee to win Orange County since 1936.

Several other candidates already have announced their intention to run against the veteran House member.

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Nationally and in California, Democrats say they have been swamped by candidates interested in running for office to oppose Trump and Republican majorities in the House and Senate. Keirstead said that is one of his motivations.

Ive come to realize more acutely than ever before the deficits in Congress and how my profile can actually benefit Congress, he said. Id like to do what Im doing but on a larger stage and I think Congress provides that, provides a forum for doing the greater good.

Keirstead was a pioneer in stem cell research, first in his native Canada and, since 2000, in Southern California. He helped lead UC Irvines stem cell research program and, in his only political endeavor, served as an advisor to a successful 2004 state measure, Proposition 71, that sought to steer $3 billion into medical research.

He also has started and sold several medical research companies that have invented therapies for ovarian, skin and brain cancer, as well as spinal cord injuries, rheumatoid arthritis and ulcerative colitis.

Keirstead has made millions of dollars off of his business endeavors but said he will not use his own money for his campaign.

Although his background gives him a network of allies to help raise money, Keirstead is likely to face criticism for leaping into politics mid-ladder, without the relationship-building that usually precedes a first run.

He became a citizen in 2008, he said. County voting records show he cast ballots in general elections that year and in 2010, 2012 and 2016. The records indicate that he did not cast any ballots in the 2014 midterm elections, and he has not voted in primary elections.

Asked about the missing votes, Keirstead said he had other commitments and responsibilities but stressed that the result of last falls elections show how important it is to participate in our democracy.

Campaign finance records show he has not donated to federal or state candidates.

In an interview, Keirstead suggested he is still studying policy positions. He said that he would prefer to improve the Obamacare insurance program rather than adopt a universal healthcare plan favored by some liberal Democrats.

I think Obamacare put in place a very large system that is fantastic in some measures and very flawed in others, he said. Theres a lot we can do with the existing system rather than cripple it first as the Trump administration is doing in order to justify a replacement.

On trade, another issue that has divided Democrats, he declined to take a position on the North American Free Trade Agreement, which Trump and some Democrats favor dumping. He also would not say whether he favored Clinton or Sen. Bernie Sanders last year.

I just dont really like the labels, he said. Im trying to run as authentic Hans. I am personally tired of partisan politics where the labels are driving the decision making. I think we should be more results driven.

But he was happy to criticize Rohrabacher for his advocacy of friendlier relations with Russia and for voting for the House Republican healthcare plan. And he also defended, with a laugh, his unorthodox path to politics.

I can tell you without a doubt my cancer treatment, my spinal cord injury treatment, would never have been invented had I followed a step-by-step straight path in academia and business, for sure, he said. Doing things differently has been responsible for my success. And its actually encouraged me to take on bigger initiatives like running for Congress.

cathleen.decker@latimes.com

Twitter: @cathleendecker

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Stem cell scientist to become the latest Democrat trying to topple Dana Rohrabacher in OC House race - Los Angeles Times

Texas has sanctioned unapproved stem cell therapies. Will it change anything? – Science Magazine

Texas Governor Greg Abbott just signed a law making it easier for unproven stem cell therapies to be given to patients in his state.

Marjorie Kamys Cotera/Bob Daemmrich Photography/Alamy Stock Photo

By Kelly ServickJun. 15, 2017 , 11:15 AM

Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the right to try laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).

In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the states official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.

You could make the argument thatif [the new law] was vigorously enforcedits going to put some constraints in place, says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics marketing directly to consumers online, 71 of which were based in Texas. But it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards, he adds. Either way, Turner says theres powerful symbolic value in setting up this conflict between state law and federal law.

The law, effective 1 September, will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissuesuch as a patients own fatif their doctor recommends it after considering all other options, and if its administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial. The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDAs lengthy approval process, provided the cells are only minimally manipulated and perform the same function they normally have in body.

The Texas bills clinical trial and IRB requirements seem to weed out some dubious therapies, but the language is too nebulous to protect patients, says Beth Roxland, a bioethicist at New York Universitys Langone Medical Center in New York City. The bill doesnt specify that a trial be conducted in the United States or that the therapy get clearance from FDA for human testing. You could gain access to something [as long as its] being studied in a human somewhere on the planet, she says, which in the stem cell area makes it really very scary.

Awareness about the risks of unproven stem cell therapies is growing. A case report published in The New England Journal of Medicine earlier this year documented three women who lost their vision after receiving purported stem cell injections meant to treat age-related degeneration of the retina. Such risks are also the subject of a news conference today at the annual meeting of the International Society for Stem Cell Research in Boston.

Roxland is also unnerved by a provision in the Texas law that would prevent any state government entity from interfering with a patients access to treatment. Hypothetically, if a state officially gets wind of nefarious doings at a for-profit clinic the state officials are now restrained from doing anything. She notes that that language mirrors a proposal in a federal bill known as the Trickett Wendler Right to Try Act, introduced in the Senate in January, which would prevent the federal government from interfering with a terminally ill patients access to an experimental drug outside of a clinical trial, and would prevent FDA from considering those patients outcomes in its drug approval decisions. Vice President Mike Pence signaled his support for the law in February and met with the family of Trickett Wendler, who advocated for right to try laws before her death from amyotrophic lateral sclerosis in 2015.

Others also believe that the Texas laws approval might signal a coming thaw in federal regulation of stem cell clinics. The FDA obviously doesnt have the manpower to watch over these people, says David Bales, chairman of the advocacy group Texans for Cures in Austin, which pushed for more patient protections in the new bill. We really feel like theyre trying to open up the floodgates.

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Texas has sanctioned unapproved stem cell therapies. Will it change anything? - Science Magazine

New Law Opens Door for Stem Cell Therapy in Texas – Spectrum News

AUSTIN, Texas -- The legal battle to get patients access to stem cell therapy in Texas is closer to reality.

Gov. Greg Abbott signed such legislation into law this week, and itmeans some patients will be heading into uncharted medical territory.

Come Sept. 1, patients with terminal illnesses or severe chronic diseases will be allowed to access experimental stem cell treatments in Texas.

MORE |Governor Signs Law to Allow Chronic, Terminally Ill in Texas to Get Stem Cell Treatments

Currently, mostpatients who want stem cell therapy have to travel outside the United States to do it, and stem cell re-injections are only allowed here within a 24-hour window.

"This is going to protect patient health, and provide for the treatments to be done here locally at home," saidMike Byrom, the Chief Science Officer at Austin stem cell bankBioEden.

Byrom said the new lawwill keep patients in the country, and will provide renewed hope for those with serious ailments.

This hope resulted in anemotional fight this session.

Texas State Rep. Drew Springer, R-Gainesville, gave an impassioned speech for the legislation as the deadline to read new bills approached, urging lawmakers to keep it from dying.

"I'll be damned if we don't get the chance tonight to hear the very next bill that opens up the doors of medical science," saidSpringer, whose wife is wheelchair-bound."It might give somebody like my wife a chance to walk."

But not everyone's convinced this is the right way to go.

"We want access for patients to the best drugs, but we think they ought to go through the FDA approval process," saidTexans for Cures Chairman David Bales.

Bales was one of the few people who testified against the bill. While he supports more stem cell research,hearguesthe state should fund it, rather than letting for-profit businesses lead the way.

"You run the risk of medical fraud because a lot of these guys, a lot of these patients, are paying a lot of money, to physicians and drug manufacturers who haven't gone through the right process,"Balessaid.

Patients who will be participating in stem cell therapy procedures will give up their right to take legal action if something goes wrong.

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New Law Opens Door for Stem Cell Therapy in Texas - Spectrum News