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Archive for the ‘BUSINESS OF STEM CELLS’ Category

NOT FDA APPROVED, NOT INSURANCE COVERED SO IT MUST BE BAD!

In BUSINESS OF STEM CELLS, HOPE AND INSPIRATION, OFF THE BEATEN PATH, STEM CELLS IN THE NEWS on February 9, 2017 at 5:37 pm
failure-missed-opps

NOT FDA APPROVED, NOT INSURANCE COVERED SO IT MUST BE BAD!

Someone reminded me that most stem cell treatments and immunotherapies aren’t FDA approved or covered by insurance in the USA.
 
This is true, but…
we’ve known about the rampant capacity for stem cells regenerating/regrowing finger tips since the work of Dr Illingsworth in the early 70’s. Children under 8 regrew their fingertips unassisted. That was their natural stem cells in their own bodies regenerating the distal phalanx, blood vessels, skin, nail, etc. but our natural healing system is not FDA approved.
 
We’ve known about bone marrow derived stem cell treatments in the form of bone marrow transplants for Leukemia/blood cancers. They regrow the patients immune system and are approved and have been used successfully in the USA for 60 years.
 
We know of stem cell treatments recovering patients from many chronic and terminal diseases successfully around the world for over 2-3 decades but that is only outside of our country and medical system for what I think are probably obvious reasons.
 
We know immunotherapy, like the 2 bubble babies cured and out of bubbles in 2001 and the Cuban originated lung cancer vaccine has been working for decades and treated thousands successfully but that is years from getting approvals here.
 
Sadly, as you said, many of these treatments – which merely expand on and accentuate the natural regenerative capacity and natural immune response capacity of the human body – are not covered by insurance or FDA approved.
 
I guess the only question I have is:
If these treatments have worked years to decades everywhere else they are used…
Is this a failing of the treatments or of the FDA and insurance…

Only you can decide.

 
“Many of life’s failures are people who did not realize how close they were to success when they gave up.” – Edison

“All that was great in the past was ridiculed, condemned, combated, suppressed — only to emerge all the more powerfully, all the more triumphantly from the struggle.” – Tesla

“Success is not final, failure is not fatal: it is the courage to continue that counts.” – Winston Churchill

“The scientific man does not aim at an immediate result. He does not expect that his advanced ideas will be readily taken up. His work is like that of the planter—for the future. His duty is to lay the foundation for those who are to come, and point the way.” – Tesla

WHAT WILL TOM PRICE MEAN TO PATIENTS?

In BUSINESS OF STEM CELLS, HEALTH AND WELLNESS, STEM CELLS IN THE NEWS on January 24, 2017 at 11:45 am

tom_price_official_transition_portrait

“Who is Tom Price, Trump’s pick for HHS?

Washington (CNN) While some Republicans have signaled major changes to Obamacare are a long time in the making, President-elect Donald Trump has sent a strong signal that the law’s days are numbered, no matter what.

That signal is Rep. Tom Price, Trump’s pick to head the Department of Health and Human Services.
The Georgia Republican and medical doctor is among the law’s most studied and determined opponents.” via

On ABORTION

  • Voted YES on banning federal health coverage that includes abortion. (May 2011)
  • Voted NO on expanding research to more embryonic stem cell lines. (Jan 2007)
  • Voted NO on allowing human embryonic stem cell research. (May 2005)
  • Voted YES on restricting interstate transport of minors to get abortions. (Apr 2005)
  • Rated 100% by the NRLC, indicating a pro-life stance. (Dec 2006)
  • Bar funding for abortion under federal Obamacare plans. (Jul 2010)
  • Prohibit federal funding for abortion. (May 2011)
  • Prohibit federal funding to groups like Planned Parenthood. (Jan 2011)
  • No family planning assistance that includes abortion. (Jan 2013)
  • Grant the pre-born equal protection under 14th Amendment. (Jan 2007)

On DRUGS

  • Voted NO on more funding for Mexico to fight drugs. (Jun 2008)
  • Rated -10 by NORML, indicating a “hard-on-drugs” stance. (Dec 2006)
  • Rated 0% by NORML, indicating an anti-legalization stance. (Jan 2014)

On ENVIRONMENT

  • Voted NO on $2 billion more for Cash for Clunkers program. (Jul 2009)
  • Voted NO on protecting free-roaming horses and burros. (Jul 2009)
  • Voted NO on environmental education grants for outdoor experiences. (Sep 2008)
  • Voted NO on $9.7B for Amtrak improvements and operation thru 2013. (Jun 2008)
  • Voted NO on increasing AMTRAK funding by adding $214M to $900M. (Jun 2006)
  • Voted NO on barring website promoting Yucca Mountain nuclear waste dump. (May 2006)
  • Voted YES on deauthorizing “critical habitat” for endangered species. (Sep 2005)
  • Stop considering manure as pollutant or hazardous. (Sep 2011)
  • Rated 13% by HSLF, indicating an anti-animal welfare voting record. (Jan 2012)
  • Strengthen prohibitions against animal fighting. (Jan 2007)

On HEALTH CARE

  • Republicans have offered ideas and solutions on healthcare. (Jan 2010)
  • Address lawsuit abuse; it doesn’t raise taxes by a penny. (Jan 2010)
  • More Medical Savings Accounts; less medical malpractice. (Nov 2004)
  • Voted YES on the Ryan Budget: Medicare choice, tax & spending cuts. (Apr 2011)
  • Voted YES on repealing the “Prevention and Public Health” slush fund. (Apr 2011)
  • Voted NO on regulating tobacco as a drug. (Apr 2009)
  • Voted NO on expanding the Children’s Health Insurance Program. (Jan 2009)
  • Voted YES on overriding veto on expansion of Medicare. (Jul 2008)
  • Voted NO on giving mental health full equity with physical health. (Mar 2008)
  • Voted NO on Veto override: Extend SCHIP to cover 6M more kids. (Jan 2008)
  • Voted NO on adding 2 to 4 million children to SCHIP eligibility. (Oct 2007)
  • Voted NO on requiring negotiated Rx prices for Medicare part D. (Jan 2007)
  • Voted YES on denying non-emergency treatment for lack of Medicare co-pay. (Feb 2006)
  • Repeal any federal health care takeover. (Jul 2010)
  • Deauthorize funding for Obamacare. (Jul 2010)
  • Repeal the Job-Killing Health Care Law. (Jan 2011)

Via 

 

On HEALTH ISSUES
Benjamin says that Price’s record in public-health policy is particularly worrying. In 2008, for instance, Price voted against allowing the FDA to regulate tobacco as a drug.

Price has also pushed to repeal the Public Health and Prevention Fund (PHPF), a roughly $1 billion to $2 billion fund provided yearly to the CDC to support public-health programmes. Owing to past budget cuts, the agency has used this money to bolster spending on existing programmes, such as research on lead toxicity. Price has criticized the PHPF as a “slush fund”, but Benjamin says that it has been essential for the agency. “Should he be confirmed, we’d be working very hard to try and change his mind to convince him that prevention is an important issue he should champion,” he says.

And Price has also consistently opposed embryonic stem cell research, saying in 2009 that Obama’s executive order to permit such research would “force taxpayers to subsidize research that will destroy human embryos”.

He has also supported numerous efforts to defund the reproductive non-profit healthcare group Planned Parenthood” Via

 

“On STEM CELL RESEARCH

Price has been outspoken against research that involves embryonic stem cells.
In 2005, Price spoke with Georgia’s Athens Banner-Herald newspaper about the “ethical dilemma” of stem cell research. Embryonic stem cells, which have the potential to treat myriad medical conditions, are controversial because they derive from early embryos.
The cells are of interest for research because they have the potential to develop into many different cell types, and so scientists believe they can be used to generate cells and tissues that could be used for cell-based therapies.

See the latest news and share your comments with CNN Health on Facebook and Twitter.

“There are people who believe any form of embryonic stem cell research necessitates the destruction of human life,” Price said. “I can’t overestimate the importance of that statement.” And for people who believe that, “stem cell scientists are threatening your fundamental principles,” he said.
According to the National Institutes of Health’s current guidelines on human stem cell research, embryonic stem cells are eligible for research with NIH funding if they were created using in vitro fertilization and are no longer needed or were donated by individuals seeking reproductive treatment.
Price has voted against expanding embryonic stem cell research. As HHS secretary he would oversee NIH grants to research on embryonic stem cells.” Via
On LGBT, DOMESTIC VIOLENCE, HUMAN RIGHTS, PERSONHOOD STATUS of EMBRYOS
Last year Price joined other Georgia Congressmen in signing a letter of support for fired Atlanta fire chief Kelvin Cochran, who was terminated after not obtaining permission to use his official capacity to promote a book he wrote that disparages LGBT people under the cloak of religion. The letter falsely described both Cochran’s actions and the reason for his termination.Price, as On The Issues details, voted against reauthorizing the Violence Against Women Act and against prohibiting job discrimination based on sexual orientation. He voted to constitutionally define marriage as one-man-one-woman and to amend the Constitution to define traditional marriage. He’s earned a 0% rating from the Human Rights Campaign and a 17% rating from the NAACP.

Rep. Price, 62, opposes a woman’s right to choose, he opposes stem cell research, and supports banning all federal funding of Planned Parenthood. He also supports granting embryos personhood status and thus equal protection under 14th Amendment.” Via 

 

What will Tom Price as head of the Department of Health and Human Services mean to you?  Please comment below.

Is Donald Trump FOR or AGAINST Stem Cells?

In ALL ARTICLES, BUSINESS OF STEM CELLS, STEM CELLS IN THE NEWS on January 17, 2017 at 11:08 am

Same old tug of war

While much has been written about this, few have answered it well.  Let’s try.  A brief recap.

  1. President-Elect is considering representative Andrew Harris (R-MD) as Director of the National Institutes of Health.
  2. “Some researchers are concerned about how Harris might approach human embryonic stem cell research. In 2005, when Harris was a member of the Maryland legislature, he led an ultimately unsuccessful effort to derail legislation creating a state [Embryonic] stem cell research fund.” via
  3. If Harris is NIH Director, he will support adult stem cells but not embryonic stem cells.

So, if Trump places Harris, there will be more support for Adult stem cells and less for Embryonic.

Is that good or bad?

  1.  While there are different stem cells sources; embryonic, adult (about 70), iPSC, etc., in the US, the POLITICAL debate is only about Embryonic vs Adult stem cells.
  2.  Embryonic stem cells are powerful BUT have a history of generating cysts, tumors, teratomas and cancer and virtually zero successes to date.
  3. Many of the 70+ adult stem cells are less powerful but…SOME may be AS powerful as embryonic stem cells.
  4. Many conditions can be treated with the adult stem cells from your own body (autologous).
  5. Adult stem cells have almost 1,000 clinical trials proving safety and efficacy.  https://repairstemcell.wordpress.com/stem-cells-for-newbies/

So…

if Trump picks Harris = Pro Adult = Anti Embryonic = Pro Treatments Now

Donald Trump And The Great Stem Cell Decision

01/16/2017 02:13 pm ET

I do not think President-elect Donald Trump has his mind completely made up on the subject of stem cell research. Certainly I cannot find any quotes from him opposing the research.

But if the President-Elect chooses representative Andrew Harris (R-MD) as Director of the National Institutes of Health, that will signify an irrevocable decision. The President-elect will have boxed himself in as an opponent not only of stem cell research supporters, but also the one in five Americans with a disability—and we, their families, who dream of cure.

Families like mine.

My paralyzed son Roman Reed’s name is on state legislation which funded the first embryonic stem cell research therapy in the nation: The Roman Reed Spinal Cord Injury Research Act of 1999. “Roman’s Law” funded Dr. Hans Keirstead’s famous method of using embryonic stem cells to “re-insulate” damaged spinal cord nerves, currently in human trials.

In California, voters backed a $6 billion stem cell program, which has led to therapies in clinical trials for blindness, diabetes, spinal cord injuries, cancer and much more.

We felt so strongly about protecting our research that we established protections for it in the California State Constitution.

This was done precisely because of political ideologues like Representative Harris, a determined enemy of the research California supports. In public and behind the scenes, Harris has worked against embryonic stem cell research since 2005, when he tried (unsuccessfully) to kill a stem cell program for his own home state of Maryland. But that was not the end of his attacks.

Harris co-sponsored a “personhood” bill, House Resolution 816, which defined every fertilized egg as a person with rights under law. Bear in mind a fertilized egg is essentially liquid, often shed unnoticed in a woman’s monthly cycle. Yet personhood bills would criminalize embryonic stem cell research.

It was almost certainly Harris who manipulated the 21st Century Cures Act so that its funds were limited to the less effective adult stem cells, with zero funding allowed for the far more powerful embryonic.

President-Elect Trump might wish to consider retaining the services of Francis Collins, the current Director of the National Institutes of Health. A born-again Christian, Dr. Collins is a moderate, not a boat-rocker. But he is also pro-stem cell.

Dr. Collins is strongly supported by such key Republicans as Lamar Alexander, Chairman, Senate Health, Education, Labor and Pensions Committee; Roy Blunt, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services; Fred Upton, Chairman, House Committee on Energy and Commerce; and Tom Cole, Chairman, House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies.

On December 2, 2016, these Republican leaders sent an open letter to President-elect Trump, recommending the retention of Dr. Collins, saying:

“Dr. Collins is the right person, at the right time, to continue to lead the world’s premier biomedical research agency. He possesses all the attributes one should have as the Director of the National Institutes of Health—intellectual prowess, renowned scientific experience, and outstanding leadership skills. We are confident that under his leadership and with Congress’ commitment to biomedical research as a national priority, the National Institutes of Health will thrive and continue to enhance the Nation’s health through scientific discovery and biomedical research.”

Selecting Francis Collins as NIH Director puts the President on the side of science.

But for all who hope for a positive stem cell policy, hiring Andrew Harris would be an absolute deal-breaker.

Don C. Reed is the author of “STEM CELL BATTLES: Proposition 71 and Beyond: How Ordinary People Can Fight Back Against the Crushing Burden of Chronic Disease”, World Scientific Publishing, Inc.

http://www.huffingtonpost.com/don-c-reed/post_13911_b_14152616.html

LORI MILLS WINS BATTLE WITH BLUE CROSS IN WAR ON CIDP

In ALL ARTICLES, BUSINESS OF STEM CELLS, STEM CELLS IN THE NEWS, VICTORIES & SUCCESS STORIES on January 9, 2015 at 8:08 pm

“A journey of a thousand miles begins with a single step.”Lao-tzu,

Lori Mills’ story is now mainstream and may affect millions of people in years to come.  You may have seen her in the dictionary under “persistence” or next to the quote: “be the change you want to see in the world.”  Certainly she is a very lucky woman.  Or maybe it’s simpler than that.  Maybe she is simply a mother and a wife who wants to live her life as best as she can without simultaneously carrying the burden of a debilitating illness.

Lori has chronic inflammatory demyelinating polyneuropathy or CIDP and she was denied insurance coverage by Blue Cross Blue Shield in the Summer of 2014.  One week ago, believe it or not, they reversed their decision. This is a huge victory for Lori in the battle with Blue Cross Blue Shield.  This is also the first of many skirmishes in her war on CIDP and a minor victory for those that follow her.  Here’s how it breaks down:

  • Be excited for Lori as she now has a chance at a better life.  She has defeated the one thing standing in her way of getting treated.
  • Don’t expect insurance companies to start caving tomorrow as BCBS has already stated with conviction that this is not to be seen as a precedent.
  • The treatment she is approved for is a clinical trial with exclusionary criteria, not from a treatment center so this is not available to the general public.

I reached out to Lori today and both she and her friends responded with grace and respect:

Hi Lori,
I’m following your story with great interest. I am a 10 year stem cell educator and while Blue Cross is clear in stating that this shouldn’t be considered precedent setting I just wanted to personally thank you for your hard work to get the doors open just a little bit more for those people who are suffering needlessly with conventional drug and treatment protocols which do not work for them. Kudos to you and yours! Wishing you the best,
David

We wish her great success and hope to do a follow up on her progress at the end of her trial.

————————-

I’d like to share something with you.  Look at the image below.  It jumped out at me.
A simple statement.  “I’m a CIDP Fighter.”
We can all understand what it means to fight a single adversary.
With awareness and education we can learn what it means to fight an invisible neurological illness like CIDP.
And that should be enough.  For anyone.  But it isn’t.

Today’s patients seek answers, seek cures, seek stem cell therapies…
but they are not just fighting their conditions…
they often are simultaneously fighting the medical establishment, fighting insurance companies, fighting ignorance and fighting resistance.
It should not be this hard.  We should do more to make it easier for patients to get the treatments they need.  We must do more.

https://i2.wp.com/api.ning.com/files/g3sZFdca7acig06FeFWUZqdRPlquxI2mTDs9uAFPDyLXkzcpRZ7I43vUcRg17SeZXVckqdfYklRANSSUHPFwBNvR9VB6NnHt/603671_10102191952132385_769765818_n1.jpg

Blue Cross overturns decision, approves stem cell transplant coverage

GREENVILLE, Mich. — Lori Mills has been approved to receive a stem cell transplant under her Blue Cross Blue Shield coverage.

The insurance company has overturned its previous denial from the summer of 2014.

In a letter Mills received January 2, 2015, Blue Cross states the company will now pay for the potentially life-changing procedure.

“I know it’s going to be a shot at a whole new life for me,” Mills said today.

She added, “I know that because of our previous interview, it really helped get this approval letter because whenever I call they talk about it.”

FOX 17 also interviewed Mills in October, questioned Blue Cross, and aired her story.

She suffers from chronic inflammatory demyelinating polyneuropathy or CIDP. Her immune system attacks her nervous system. She shakes, has numbness, and it impairs her movement.

Doctors told her a stem cell transplant could be the cure.

via

RELATED ARTICLES:

NONMYELOABLATIVE AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR REFRACTORY CIDP

http://www.neurology.org/content/69/18/1802.short

Haemopoietic stem cell transplantation—an evolving treatment for severe autoimmune and inflammatory diseases in rheumatology, neurology and gastroenterology

http://www.maneyonline.com/doi/abs/10.1080/10245330701255106

Autologous haemopoietic stem cell transplantation for autoimmune diseases
http://informahealthcare.com/doi/abs/10.1517/14712598.2011.580272

WHAT DOES THE FOXO1 SAY? HERE’S MORE INSULIN!

In ALL ARTICLES, BUSINESS OF STEM CELLS on July 5, 2014 at 10:20 am
It May Take Guts to Cure Diabetes -Human GI Cells Retrained to Produce Insulin

Imagine taking cells from your gastrointestinal tract and then switching off one gene, the FOXO1 gene, and then ending up with insulin producing cells.  From gut cell to diabetes fighter in one easy gene switch-off.  Scientists did this successfully in 2012 in mice and recently in humans.  What does the FOXO1 say? ‘Here’s more insulin!’  Awesome.

The next step is where it gets…awkward.  I’d like this information to generate a gene therapy protocol or to improve success rates in stem cell/Diabetes treatment protocols,  etc.  But that’s not the way our system works.  The next step is to find a drug that inhibits the FOXO1 gene so it “…could retrain cells inside a person’s GI tract to produce insulin…”  Unfortunately, this drug will also have side effects as all drugs do which will create other symptoms requiring other drugs to mitigate.  And so it goes.

When will US Diabetes patients be able to benefit from a medical protocol based on this discovery?  An educated guess puts it at:
7-10 years for clinical trials and drug development for a name brand Pharma product and then 10-15 years for the drug patent to open up to an affordable generic.
Sorry Diabetes patients.

New York, NY (June 30, 2014) “By switching off a single gene, scientists at Columbia University’s Naomi Berrie Diabetes Center have converted human gastrointestinal cells into insulin-producing cells, demonstrating in principle that a drug could retrain cells inside a person’s GI tract to produce insulin…The Columbia researchers were able to teach human gut cells to make insulin in response to physiological circumstances by deactivating the cells’ FOXO1 gene.”

DUKE CORD BLOOD STUDY TARGETS AUTISM

In ALL ARTICLES, BUSINESS OF STEM CELLS, SCIENCE & STEM CELLS, STEM CELLS IN THE NEWS on June 24, 2014 at 9:02 am

It’s about time!

autistic child
Duke cord blood study targets autism

Jun. 17, 2014 @ 11:48 AM

“Doctors have used umbilical cord blood stem cells to treat diseases ranging from acute lymphoblastic leukemia, thalassemia major and sickle cell.
Now a partnership between ViaCord and Duke University Medical Center hopes to learn whether an infusion of cord blood cells can treat children diagnosed with autism spectrum disorder.

The single-site Phase I safety study includes 20 children who are 24-72 months old and diagnosed with ASD.
The Centers for Disease Control and Prevention reported that 1 in 68 children in the United States have the disorder, up 30 percent from two years ago.
“We are pleased to collaborate with Duke University Medical Center by sponsoring this important study to determine the safety of cord blood for potentially treating this prevalent disorder facing children worldwide,” said Morey Kraus, ViaCord’s chief scientific officer.
It’s a critical first step, said Dr. Joanne Kurtzberg at Duke.

“We hope to learn whether cord blood infusions are safe and to define the best tests to use to study the effects of cord blood in future studies,” she said.
Duke’s also using cord blood for a cerebral palsy clinical trial.”

Follow on Twitter at @HS_WesPlatt. Connect on Facebook at facebook.com/wesplattheraldsun.


REDUCING STEM CELL MIGRATION/ADHD TO FOCUS HEALING

In ALL ARTICLES, BUSINESS OF STEM CELLS, SCIENCE & STEM CELLS on June 23, 2014 at 2:55 pm

broken-bone-cast

REDUCING STEM CELL MIGRATION/ADHD TO FOCUS HEALING
“Stem cells are smart and will only stay in one place to repair damaged cells and tissues until called away for more dire situations requiring attention.  Like little ADHD multi-tasking mechanics/repairmen, they run all over the body where the body has decided (through a very complex set of devices) they are most needed.  This results in stem cells dedicated to mending bones, suddenly running off to fix the heart, pancreas, etc before finishing the job on the broken bone.  While this is a great holistic and triage approach (paying attention and dedicating resources to that which needs it most), it makes it difficult to access how powerful and successful stem cells are at resolving a single issue/condition in the body.

A lot can be said for repairing many areas in the entire body simultaneously, in fact, this is one of stem cells’ greatest strengths…but it doesn’t sit well with the concept of “completing one job before moving on to another.”  Scientists have devised a new way to make stem cells stay put and finish the job they were directed to do.  No more stem cell ADHD.

keep-calm-and-oh-look-a-squirrel-1

In the case of serious and terminal diseases, this is an excellent innovation.  If you can fix that which is going to fail first, you can then move on to what’s next.  It also makes commercialization of stem cells easier.  Nobody picks up their car with the damaged exhaust from the mechanic and he says: ‘I got the exhaust half done but realized your distributor, struts and alternator were shot so I fixed them instead.’  But your body is not a car.

This may be a wonderful innovation or it may be another instance of scientists trying to aggressively control a natural healing system in the body.  I think it’s both and the result is we now have one more extraordinary tool for fighting disease…and like any tool, it will be used well and for the right reasons and results and also used poorly for the wrong reasons and results.  Ultimately, our understanding of the modus operandi of stem cells has increased, our ability to manipulate stem cells has increased and the everyday miracles of stem cell treatment results are getting better and better understood and more common place all the time.” – David Granovsky

 ——————-

Delivering Capsules of Stem Cells Helps Repair Injured Bones

“One trouble with stem cells is that they don’t stay put. When doctors put cardiovascular progenitor cells in the heart to heal damage from a heart attack, the cells are whisked away in the bloodstream in a matter of hours.

Researchers, and a couple of renegade doctors in Colorado, have shown that stem cells do help bones heal. While bones, even the intricately shaped jawbone, have been grown in the lab, researchers have been somewhat stymied in their efforts at the seemingly more banal task of using stem cells and grafts to help heal major fractures, bones removed in surgery and other hard-to-fix injuries inside the body.

That’s where materials science comes in.

University of Rochester biomedical engineer Danielle Benoit encapsulated bone progenitor cells in a hydrogel wrapper and placed it on the bone she aimed to heal. Benoit hoped the wrapper would result in fewer stem cells being washed away and more sticking around to do the work of healing the bone…”

via
​http://singularityhub.com/2014/06/23/delivering-capsules-of-stem-cells-helps-repair-injured-bones/

Parkinson’s patients fund their own stem cell research

In BUSINESS OF STEM CELLS, SCIENCE & STEM CELLS, STEM CELLS IN THE NEWS on March 19, 2013 at 9:00 am

parkinsons

Healing Parkinson’s patients with their own stem cells

Up to 1 million Americans have Parkinson’s, according to the Parkinson’s Disease Foundation. Because aging is the chief risk factor for the disease, the patient population is expected to increase as the baby boom generation gets older.  Parkinson’s selectively kills brain cells that make the neurotransmitter dopamine, which enables movement. No one knows how it happens, or how to stop it. Researchers expect that transplanted dopamine-producing brain cells will eventually die, but perhaps not for 10 to 15 years.

The most visible symptoms of Parkinson’s include tremors, slowed movement, stooped posture and loss of balance, and trouble speaking. People sometimes walk with a shuffling gait, and they may experience severe and chronic pain. Patients’ faces can assume a mask-like expression.  Drugs that provide dopamine or mimic its effects can partially relieve the symptoms, but they produce side effects such as uncontrolled movement. Also, their effectiveness decreases over time.

A groundbreaking stem cell treatment for Parkinson’s disease is getting close to moving from lab research in La Jolla to therapy for patients. The research, funded by the patients and their supporters, could also pioneer a new model for moving medical advances from the lab into the clinic.

Eight Parkinson’s patients have allied with scientists from The Scripps Research Institute and medical professionals from Scripps Clinic for the project, which involves creating new brain cells from other cells in their own bodies. Because of the unusual, personalized nature of the research, the patients are participating with scientists and doctors as equals, meeting regularly to review the progress.

The ambitious goal is to relieve the movement difficulties Parkinson’s causes by replacing the brain cells the disease destroys. In theory, it would restore near-normal movement for a decade or more, and the procedure could be repeated as needed.

Research is far enough along that scientists and health care professionals in the project are talking to regulators about beginning clinical trials, perhaps as soon as next year.

The replacement brain cells are now being grown in a lab at The Scripps Research Institute. Patches of skin the diameter of a pencil eraser were removed from the patients’ arms and turned into a new kind of stem cell that acts like embryonic stem cells. Called induced pluripotent stem cells, they were discovered in 2006, a feat honored by a Nobel Prize last year.

These IPS cells can become nearly any kind of cell in the body… Another potential advantage of IPS cells over embryonic stem cells is that they should be less prone to rejection by the patients’ immune systems, because the transplanted cells come from the individuals themselves.

Patient Cassandra Peters, 57, learned of the reality of Parkinson’s and the hope of a new treatment in a visit with Dr. Houser, her neurologist.  “Interestingly, when I first had a conversation with her, when she definitively told me I had Parkinson’s, she said to me, quote, “You will have a stem cell procedure in your lifetime.”  I took that ball and held it in my heart, thinking, this is going to be my ‘get out of jail free’ card.  Not a day goes by when I don’t have an opportunity to share what I’m going through now and what the future might hold,” Peters said.

Ileana Slavin, a research associate in the lab of Jeanne Loring, and Suzanne Peterson, a staff scientist, discuss what it means for scientists to directly meet the people they’re trying to help.  Diabetes researcher Matthias von Herrath of the La Jolla Institute for Allergy & Immunology said the work could help scientists developing stem cell therapies for diabetics,” von Herrath said. “And that’s going to open the door for these type of stem cells.”

Loring’s researchers are reaching the final stages of their part of the project. They have made induced pluripotent stem cells from all eight patients, and have turned those into the needed brain cells for two of them. The work continues for the other six.

Parkinson’s represents the “low-hanging fruit” of neurological diseases for stem cell therapy.  We know what cell types are lost in Parkinson’s disease,” Bratt-Leal said in a March 8 meeting of the group. “We can make them from stem cells.  And now we can make stem cells from adult tissues.  The next logical step is to make these cells from people and put them back into them.”

“With IPS cells grown from the patient, rejection should be less of a worry”, Bratt-Leal said.

Now that the research side of the project has overcome its greatest hurdles, the focus is shifting to medicine, Loring said. The replacement brain cells will be grown in a clinical grade facility at the City of Hope in Los Angeles.  As part of the transition to the medical side, Houser will provide expertise in setting up the clinical trial, assuming approval is granted by the U.S. Food and Drug Administration.

Beyond the potential benefit to the eight patients, the project may provide an answer to what Loring and other researchers call the “Valley of Death,” the period that halts promising research before it can become a medical treatment.  Most scientific research is federally funded, but commercialization is left to the private sector. If companies don’t see a way to make money, they won’t pursue a therapy, even if it works.  This problem is especially forbidding for treatments customized to individual patients. These don’t produce economies of scale, and hence are not attractive to pharmaceutical companies.  Advocates of the customized Parkinson’s therapy said it will pay off in the long run. Patients will require less medical care, and find it easier to maintain their jobs.

To Read Full Article click HERE.

Gastrointestinal motility disorders addressed with Stem Cells

In ALL ARTICLES, BUSINESS OF STEM CELLS, STEM CELLS IN THE NEWS on February 2, 2013 at 8:08 am

Zhang_neural_stem_cells04

Neural stem cell transplantation shows promise against gastrointestinal motility disorders

Proper function of the digestive system requires coordinated contraction of the muscle in the wall of the intestinal tract, regulated by the enteric nervous system. Damage or loss of these neurons can result in intestinal motility disorders, such as Hirschsprung’s disease, for which there is a dearth of effective treatments. In principle, disorders of the enteric nervous system could be treated by cell therapy, but it was previously unknown whether transplanted stem cells could migrate to the appropriate location in the gut and then become neurons that could properly innervate the bowel.

In the article, “Transplanted progenitors generate functional enteric neurons in the postnatal colon”, Journal of Clinical Investigation, Heather Young and colleagues at the University of Melbourne, isolated neural stem cells from mice, cultured them to promote the formation of neural precursor cells, and implanted them into the muscle in the colons of recipient mice. Young and colleagues found that these cells were able to migrate away from the transplantation site and develop into neurons that provided stimulation to the portions of the gut the regulate motility. These findings suggest that the transplantation of neural stem cells is a promising therapeutic avenue for the treatment of gastrointestinal motility disorders.

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STEM CELL TREATMENT FOR DEGENERATING INTERVERTEBRAL DISCS

In ALL ARTICLES, BUSINESS OF STEM CELLS, STEM CELLS IN THE NEWS on January 13, 2013 at 9:53 am

spine-stem-cells

Stem cell treatment for spine tested

An Australian-invented stem cell treatment for spinal surgery has been successfully used for the first time in the United States.  The patented stem cells product created by Melbourne-based company Mesoblast was trialed in a small group of patients with spinal discs that had degenerated beyond repair.  The bone marrow-derived stem cells – called mesenchymal precursor cells (MPCs) – were used to promote bone growth to fuse together spinal vertebrae, to eliminate debilitating leg and back pain.

If the procedure ultimately passes the final stage of clinical trials and is approved by America’s drug regulator, it would potentially provide patients worldwide with a quicker and less invasive procedure.

The Food and Drug Administration (FDA)-approved trial compared the use of stem cells to fuse vertebrae with bone harvested from the patient’s own hip, the current gold standard for this common operation.  The stem cells were used in conjunction with two chemicals to encourage bone growth, said Texas surgeon Dr Randall Dryer, who performed a number of surgical procedures in the trial.  The chemicals, hydroxyapatite and tricalcium phosphate, are non-cellular components of bone that tell the stem cells to turn into bone-forming cells, rather than other tissues, “If you put these cells into an environment that stimulates them to grow into bone, they do.  That eliminates us having to take the patient’s own bone from a different location to pack in there“, said Dr. Dryer, an orthopedic surgeon at the Central Texas Institute in Austin.

Eight of the 24 patients enrolled in the trial had the surgery using their own bone.  Of these, six patients’ bone had successfully fused after a year.  Six out of seven patients given a low concentration of stem cells had equally successful results, while five out of eight patients given a higher concentration of stem cells achieved the bone fusion.  “These stem cells work at least as good as or better than the patients’ own bone.”  The advantage of the operation is that it cancels the need to harvest the patient’s own bone, which lengthens the surgery time, is more painful and can lead to more complications.  This is hopefully going to be a new tool that we can use to help patients recover less painfully, quicker and with just the same effectiveness.” There were no adverse events in the phase two trial, which tests the product for safety and efficacy.  The company plans to apply for FDA approval to conduct a larger phase three trial in the United States, Europe and Australia later this year.

http://www.theaustralian.com.au/news/breaking-news/stem-cell-treatment-for-spine-tested/story-fn3dxiwe-1226551833859

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