Category Archives: Minnesota Stem Cells

The following 13 research projects were selected for Regenerative Medicine Minnesota grants from 61 applications.These grants are effective for a two-year period, 2018-2020.CLINICAL TRIALS (research in human patients)

Mohamad Bydon, MDCELLTOP: A Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury

Aaron Krych, MDThe RECLAIM trial for focal cartilage repair

Terence Burns, MD, PhD Safety and mechanisms of senolytic therapy for central nervous system rejuvenation.

Ping Chen, PhD Regeneration of hypothalamic neuro-architecture using liver enzyme gene transfer as an approach to treat post-dieting body weight rebound

Daniel Garry, MD, PhD Bioengineering strategies for cardiovascular disease and regeneration

Nobuaki Kikyo, MD, PhDCircadian rhythm-based differentiation of iPS cells to cardiomyocytes

Raghavendra Rao, MDNeuroprotection Using Human Extremely Low Gestational Age Neonate-Derived Umbilical Cord Blood Stem Cells in Neonatal Hemorrhagic Brain Injury

Jennifer Westendorf, PhD Girk channels in cartilage development and repair

Marija Cvetanovic, PhDDetermining therapeutic potential of BDNF in delaying the onset and progression of Spinocerebellar ataxia type 1 (SCA1)

Joseph Lillegard, MD, PhDGene Therapy of Hereditary Tyrosinemia Type I using in vivo Lentiviral Vectors

Troy Lund, MD, PhDAccelerating Hematopoietic Cell Regeneration

Alexander Revzin, PhDEngineering microcapsules for stem cell cultivation and transplantation

Robert Tranquillo, PhDRegenerative vein valve

Current Awards

Past Awards

Read the original:
2018 Regenerative Medicine Minnesota Research Awards

California Stem Cell Treatment Centers has not responded to requests for comment.

StemImmune is "fully cooperating with the FDA about the development of its stem cell-based investigational cancer therapy," Ulrike Szalay, a spokeswoman for the company, wrote in an email. "We look forward to continuing our dialogue with the FDA."

"It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures," she wrote. "The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals."

Comella wrote that the surgical procedure used by the clinic is "not subject to the rules for tissue banks which include minimal manipulation and homologous use" as described in current federal regulations. She concluded, "our clinic is not violating the law as it is currently written."

The International Society for Stem Cell Research commended the FDA for its policy direction and enforcement efforts. President Hans Clevers said the society has been "very concerned" about reports of patients using unproven stem cell therapies.

"Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies," Clevers said in a statement. "We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients."

"I've directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health," Gottlieb wrote. "We have examples where some of these unproven treatments have clearly harmed patients."

"I wish it hadn't taken this long," said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota. "This is a space where the FDA could have taken action four or five years ago as far as making this a policy priority."

Turner said he sees the steps announced Monday as both important and necessary, yet he remains skeptical.

"There are important distinctions to be made, and the FDA seems to be making these distinctions in terms of suggesting that they are putting together this working group, a task force, going after businesses marketing unproven interventions, going after businesses making illegitimate or unwarranted claims about stem cell treatment," he said.

What will trigger regulation?

Gottlieb wrote in his statement "it's incumbent upon the FDA" to make sure the existing legal and regulatory framework is properly defined, with "bright lines" separating individualized or tailored therapies surgeons are permitted to use from new treatments subject to regulation. Because the field of regenerative medicine is rapidly evolving, he said, close calls may be frequent between what constitutes an individualized treatment and what constitutes an unapproved, possibly harmful medical product.

Turner said Gottlieb's statement allowed for "a bit of slippage as far as what exactly the FDA is going to do and which businesses they are going to target."

Questions remain as to whether the warning letter is a sign of more letters to come and whether we will see "a dramatic increase" in such activities from the FDA, Turner said.

FDA spokeswoman Lyndsay Meyer wrote in an email that the agency "will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line."

Yet, Turner asked, what is enough to trigger FDA regulation? Are marketing campaigns and commercial activity enough?

"Or do we actually require people being blinded before the FDA does something?" he asked, noting that "there's a considerable amount of uncertainty in terms of what we should expect in the months ahead. The statement itself doesn't provide clear answers to all those questions."

Susan L. Solomon, CEO of the New York Stem Cell Foundation, a nonprofit research organization, said via a spokesman that "the regulation of these clinics is very difficult, so the announcement today that the FDA will be stepping up their oversight should be welcomed and applauded."

Overall, Turner said, the agency's actions should not give all stem cell treatments or doctors performing these regenerative therapies a bad name. There are already effective treatments. "If we think about bone transplants as stem cell transplants, it's standard of care for certain diseases," he said.

Solomon agreed: "There are extremely promising studies and research using stem cells to treat macular degeneration, multiple sclerosis, diabetes and many other devastating diseases. I cannot emphasize enough how exciting and promising the research is.

"However, anyone advertising a 'cure' today is simply taking advantage of patients for their own financial gain," she said.

What patients need to know

Turner acknowledges the difficulty for patients, who may not easily recognize which stem cell therapies are approved and beneficial and which are not.

"If you see a business that's making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of," he said.

Turner acknowledged stem cell treatments as "a very promising area of research," and over time, he expects to see more FDA-approved therapies in the marketplace. The problem, he said, is that many American businesses making claims about stem cell treatments lack proper scientific safety and efficacy data.

"Why, for example, didn't California Stem Cell Treatment Centers get a warning letter for all the other treatments they are doing? It leaves me a bit perplexed," he said. "Why is the FDA so focused on these vials and not on the broader array of marketing claims that California Stem Cells was making?"

Solomon said that "by providing unproven treatments to chronically ill or injured patients," these clinics are not only taking advantage of patients, they are "muddying the scientific waters of clinical trials that are trying to show whether a treatment does or does not work."

In its statements Monday, the FDA notes the "handful of bad actors" in the stem cell space, Turner observed. (Meyer repeated the FDA's assertion that it's only "a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine.")

Ultimately, Turner is glad for the FDA's actions.

"I hope this is a sign that the FDA is going to do a lot more and better regulate this market space so we'll see whether or not that happens," he said. "It's easy to make these bold announcements. The question is going to be whether anything really comes of it."

Correction: Previous versions of this story included quotes attributed to David McKeon, a spokesman for the New York Stem Cell Foundation; they should have been attributed to foundation CEO Susan L. Solomon.

Read the original:
FDA cracks down on stem cell clinics - CNN

Researchers at the Mayo Clinic and the University of Minnesota say theyre on the brink of a new era in cancer care one in which doctors extract a patients white blood cells, have them genetically engineered in a lab, and put them back to become personalized cancer-fighting machines.

The so-called CAR T cellular therapies are expected to receive federal approval this fall for certain rare blood cancers B-cell forms of lymphoma and leukemia. But scientists at the Minnesota institutions hope thats just the first step that will lead to better treatment of solid tumor cancers as well.

This is really the first approval of a genetically modified product for cancer therapy, said Dr. Jeffrey Miller, deputy director of the Masonic Cancer Center at the University of Minnesota. If the proof of concept works, he said, we might be on the right track to get away from all of that toxic chemotherapy that people hate.

Participating in industry-funded clinical trials, the Minnesota researchers hoped to determine if patients with leukemia or lymphoma would be more likely to survive if their own stem cells were extracted to grow cancer-fighting T-cells that were then infused back into their bodies.

One analysis, involving trials by Kite Pharmaceuticals at Mayo and other institutions, found a sevenfold increase in lymphoma patients whose cancers disappeared when they received CAR T instead of traditional chemo-based treatment.

I often tell patients that T-cells are like super robocops, said Dr. Yi Lin, a Mayo hematologist in Rochester. Were now directing those cells to really target cancer.

The U.S. Food and Drug Administration is widely expected this fall to approve CAR T products made by Kite and Novartis, which genetically engineer T-cells to target so-called CD19 proteins found on the surface of leukemia and lymphoma cells.

The side effects can be harsh, because the T-cell infusions trigger an immune system response that can produce fever, weakness, racing heart and kidney problems. Short-term memory and cognitive problems also have occurred. Brain swelling led to five deaths of cancer patients who took part in a CAR T trial by Juno Pharmaceuticals. The trial was shut down as a result.

Lin said brain swelling appeared mostly in adults with leukemia. For now, she expects Kites CAR T therapy to be approved for diffuse large B-cell lymphoma and the Novartis therapy to be approved for acute lymphoblastic leukemia in children. Federal regulations also might restrict CAR T for patients whose cancers survived traditional treatments.

Current practice to treat these cancers generally involves chemotherapy and radiation. Physicians then transplant stem cells, often from donor bone marrow, to regrow the patients immune systems, which are weakened in the process of treatment.

CAR T differs in that patients will receive infusions of their own T-cells, genetically modified, which their bodies will be less likely to reject.

Its individualized medicine, Lin said.

Im on my way

Before he tried CAR T at Mayo as part of a clinical trial, John Renze of Carroll, Iowa, had received two rounds of chemo, two rounds of radiation, and an experimental drug that did nothing to stop the spread of lymphoma.

After you fail about four times, you start to wonder if anything is going to work, the 58-year-old said.

At first, there was no room for him in the Mayo trial which has been a problem nationwide as desperate cancer patients have searched for treatment alternatives. But then he got the call one morning last summer while ordering coffee at his local cafe.

Can you get up here by one? the Mayo official asked.

Im on my way, Renze replied.

Even before federal approval comes through, researchers such as Miller are looking beyond the first-line CAR T therapies, and wondering if the approach can be used on solid tumors. Roughly 80,000 blood cancers occur each year in the U.S. that could be treated with CAR T, but the total number of cancers diagnosed each year is nearly 1.7 million.

The challenge is that solid tumors dont have the same protein targets as blood cancers. And T-cells would have to be more discriminating if infused to eliminate tumors in solid organs, Miller said. If you destroy normal lung tissue (along with lung cancer), thats not going to work, he said.

Mayo researchers are studying whether CAR T can work against multiple myeloma, a cancer of the bone marrow, while U researchers are exploring ways to better control the CAR T-cells after they are infused in cancer patients.

Researchers also are trying to understand whether CAR T produces memory in the immune system, so it knows to react if cancers resurface.

In addition, Miller is studying whether NK cells, which also play a role in the human immune system, can be genetically modified and infused instead of T-cells to target cancer. The body doesnt reject NK cells from donors as much, he said. So NK cells from donor bone marrow or umbilical cord blood could be collected and mass produced to potentially provide faster and cheaper treatments.

Like many breakthrough therapies, CAR T will be expensive, with a price likely to exceed $200,000 per patient. How insurers plan to cover it remains unclear. Blue Cross and Blue Shield of Minnesota is evaluating evidence regarding CAR Ts effectiveness, and will set a coverage policy after it receives FDA approval, said Dr. Glenn Pomerantz, Blue Cross chief medical officer.

A surge for Mayo?

Mayo expects a surge of hundreds of cancer patients per year if CAR T is approved, because it will initially be provided by large medical centers that have experience with the therapy and its side effects. The Rochester hospital is planning to add staff and space dedicated to CAR T.

Miller said the U is developing advice for referring doctors and hospitals statewide, so they know what to do if CAR T patients show up with complex symptoms.

They can be a bit delayed and you cant just keep people in the hospital to see if they develop these things, he said.

Renzes stem cells were taken last July, and his modified T-cells were put back a month later. He lost weight and felt sick for weeks, and had to drive three hours to Mayo for frequent checkups.

But as of last Aug. 31, the cancer had vanished.

Every three months, he returns to Mayo to make sure the cancer hasnt re-emerged. Then he returns to Carroll, where he owns farmland and car dealerships and dotes on his grandchildren.

For people like me that have already failed a bunch of times, youre happy to try anything, he said. I mean, what else would I have done?

See the article here:
Mayo Clinic, University of Minnesota develop 'robocop' stem cells to fight cancer - Minneapolis Star Tribune

Upon arriving in McLeod, North Dakota, Saturday morning it was evident something special was going on.

Horses waited for riders on every street in town. Cowboy hats and horse trailers were everywhere throughout the city as anticipation built for an extraordinary fundraiser to begin.

Riders and horses hit a 12-mile track Saturday, Aug. 19 that was more than a trail ride. Cowboy Up Ride Against Cancer is in its 13th year. Participants paid to join the ride to raise money for cancer research and to help patients at the Roger Maris Cancer Center in Fargo.

To cowboy up means whenthingsgettoughyou have to get back up,dustyourself off and keep trying. Anyone battling cancer knows how this slogan applies to their fight.

The color in this years ride was red, which is the representative color for multiple myeloma cancer. Patty Dick, Engelvale, North Dakota, was the guest speaker for the opening ceremony. She told her cancer story, a battle she will not win. Multiple myeloma has no cure, but each day since her diagnosis gives her children and grandchildren more time to make memories. Multiple myeloma, sometimes called bone marrow cancer, affects plasma cells elevated protein levels in her blood in April 2011 during a routine wellness check. Patty was told there are few reasons for elevated levels the most likely was cancer. More tests continued to show higher protein levels with calcium deposits also showing up. She was told the myeloma cells were crowding out bone cells. A bone marrow biopsy gave doctors a diagnosis, multiple myeloma.

The next few years were a watchful wait, she told the gathered audience at Cowboy Up. In late winter 2014 her cancer had reached a stage where her levels warranted increased care.

Its time we start treatment, her doctor said.

That summer she took four rounds of oral chemotherapy, a pill she took each day for 21 days straight with seven days off. The pill prepared her for a stem cell transplant scheduled for the winter. Doctors harvested her own stem cells and she underwent a transplant in December 2014. She and her husband, Mike, moved to Rochester, Minnesota, for a two-month stay during that time frame. Their five children took turns traveling to Rochester to be with them as she underwent the stem cell transplant. She was told there was danger of infection for those two months and she would need caregivers as she started a clinical trial of high-dose chemotherapy.

Although her story was difficult to tell, Patty shared some positive information. People with cancer are living longer and having greater quality of life during their survivor years, she said.

Im still fighting my battle, Patty said as horses along the streets talked to each other with whinnies and neighs. Higher protein levels showed up again.

In January 2017 she began immunotherapy. The treatments gives her hope, a message that people who battle cancer share. When lives are in danger hope is sometimes all there is.

A second guest speaker was a young boy from St. Joseph, Missouri. Weston Luebke explained how at Christmas he asked Santa for $200 to help breast cancer patients. Santa worked hard and gave him $200 for Christmas, but Weston wanted to do more. He and his family came up with the idea to create cancer bags. He gives these bags to people undergoing breast cancer treatments in St. Joseph, a bag that contains a blanket, peppermint, lotion, hand sanitizer and a game book. The hope is the bags will distract patients as they undergo treatments.

He and his family were increasing their donation circle to include the Roger Maris Cancer Center in Fargo. His mother is from McLeod, so attending the annual ride is part of their August vacation. This year though, Weston brought some cancer bags to give to upper Midwest patients.

At the conclusion of the ceremony, the restless horses took over and the ride officially began.

View post:
Cowboy Up Ride Against Cancer - Wahpeton Daily News

Cargill, Inc., announced it has joined billionaires Bill Gates and Sir Richard Branson investing in Memphis Meats, a San Francisco-based start-up making real animal beef, chicken and duck from single cells. http://kare11.tv/2v7WbBh

Christoper Hrapsky, KARE 10:39 PM. CDT August 23, 2017

Cargill, Inc. announced it has joined billionaires Bill Gates and Sir Richard Branson investing in Memphis Meats, a San Francisco-based start-up making real animal beef, chicken and duck from single cells. (Photo: Courtesy Memphis Meats)

MINNETONKA, Minn. - The meat industry is taking a futuristic leap from pasture to Petri dish.

Cargill, Inc., announced it has joined billionaires Bill Gates and Sir Richard Branson investing in Memphis Meats, a San Francisco-based start-up making real animal beef, chicken and duck from single cells.

The new industry, dubbed clean or lab-cultured meat, uses self-reproducing muscle stem cells to make the meat without slaughtering a single animal.

It tasted like duck, said Sonya Mccolum Roberts, president of growth ventures for Cargill Protein, who recently tasted a sample of Memphis Meats' product. We are still all about our traditional proteins, but this is an opportunity for us to provide something additional to customers who want something different.

Memphis Meats has a Minnesota connection. The company was co-founded by former Mayo Clinic cardiologist Dr. Uma Valeti.

He was already growing tissue for his work, and he decided, Well, if I can do it here, why can't I do it in other avenues and specifically food? said Roberts.

Considering the environmental cost of traditional meat farming, the feed cost, the antibiotics, and the finite ability to use more land and water, Cargill sees Memphis Meats as another option for the future of a growing population that will demand more meat.

The first lab-cultured hamburger was created in 2013 by Mark Post, M.D., a Dutch professor who used 20,000 muscle strands grown in his laboratory, according to New Harvest, an industry nonprofit.

The discoveries have led multiple companies to pursue clean meat commercially.

Memphis Meats says it could go to market in four or five years, but costs will need to scale down.

Right now, according to Roberts, one pound of lab-cultured meat costs about $2,400.

2017 KARE-TV

Continued here:
Cargill invests in 'clean meat' start-up - KARE

Clinics that offer unproven stem-cell therapies have begun to use a website run by the National Institutes of Health (NIH) to recruit paying patient-customers, according to an article published last week in the journal Regenerative Medicine by Leigh Turner, a bioethicist at the University of Minnesota.

The website is ClinicalTrials.gov, which is a registry of public and private clinical trials (research that uses human subjects) being conducted around the world. People with a chronic illness sometimes use the site to see if there is a clinical trial that they might qualify for, usually with the hope that the new treatment being tested might improve their medical condition and their quality of life.

Most researchers who list their studies on ClinicalTrials.gov do not charge patients to participate, and if they do, it is only a nominal amount and after first receiving approval from the Food and Drug Administration (FDA) to do so.

Turner has found, however, that clinics selling dubious stem-cell treatments are now listing equally dubious clinical trials on the NIH website studies for which they are charging patients thousands of dollars.

Often, there is no hint on ClinicalTrials.gov that these are pay-to-participate stem-cell studies. Patients discover that only when they call the clinic to ask about enrolling in the trial.

Most patients are also unaware that those pay-to-participate studies are highly questionable, with inadequate peer-reviewed preclinical research (to make sure that there is substantial evidence that the treatment is safe) and inappropriate study-designs (such as not randomizing patients to different treatment groups and not using placebos or sham procedures to control for placebo effects).

The clinics are basically trying to take advantage of the perceived legitimacy and credibility of the website, said Turner in an interview with MinnPost. They want to suggest that if their studies are on this site, then they must be legitimate.

The problem is that anybody can sit at his computer, enter pretty much anything, press submit, and get on ClinicalTrials.gov, because the screening is inadequate, he added.

Earlier this year, NIH made its disclaimer regarding ClinicalTrials.gov more prominent. Patients who click on the site now see a statement across the top of the sites home page that says, Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted health care professional before volunteering for a study.

That change was made after an article published in March in the New England Journal of Medicine described how three women in their 70s and 80s had developed severe vision loss in one case, total blindness immediately after undergoing an unapproved stem-cell procedure for age-related macular degeneration (AMD) at a Florida clinic.

At least one of the women said she had learned about the procedure after reading about it in a study description posted on ClinicalTrials.gov. She and the other women each paid $5,000 to the clinic for the treatment.

As Ive written here before, only a fewstem-cell therapieshave been shown through clinical research to be safe and effective for treating medical conditions, mostly cancer and blood and immune disorders. Yet that hasnt stopped hundreds of clinics across the United States including here in Minnesota from marketing unapproved stem-cell therapies for a long and widely diverse list of other conditions, including (in addition to AMD) aging skin, sports injuries, sexual dysfunction, HIV/AIDS, autism, dementia, chronic obstructive pulmonary disease (COPD), Parkinsons disease and multiple sclerosis.

In a study published last year, Turner identified 351 companies in the United States that are engaging in direct-to-consumer advertising of stem-cell therapies at 570 individual clinics across the country. Most of these companies marketautologous stem cells, which are derived from cells collected from the patients body (often from fat tissue) and then injected back into the patient.

Leigh Turner

In his current paper, Turner found that such companies had successfully registered seven patient-sponsored, patient-funded, or self-funded autologous stem-cell studies on ClinicalTrials.gov. These are all studies for which the patient must pay $6,000 or more in order to participate. Another 11 studies listed on the site make no mention not even through coded terms like patient-sponsored that a fee will be charged. The patients learn that they must give the clinic money only when they seek out further information from the company or clinic sponsoring the trial.

These are junk studies that are nothing more than marketing devices, said Turner.

People can spend a lot of money not only for no real benefit, but no real prospect of benefit, for the treatment was never going to work, he added.

In some cases, patients undergoing an unproven stem-cell treatment will forgo therapies that research has proven to be effective at managing their chronic disease, he added.

And then there is the real possibility that the dubious stem-cell studies will lead directly to physical harm, as demonstrated by the cases of the Florida women.

Indeed, in another Florida case, a cardiologist lost his medical license after a patient died in 2012 while undergoing an unproven stem-cell procedure at his clinic a procedure for which the patient reportedly paid $54,000.

Turner applauds the placing of a more prominent disclaimer on the ClinicalTrials.gov website, but he believes that action alone is insufficient to protect the public from unscrupulous stem-cell clinics. Federal officials need to vet all studies before they go up on the site, he says, to ensure each one meets certain basic requirements such as getting FDA approval before charging patients to participate.

The cost of such vetting to the government would be minimal compared to the benefit it would bring vulnerable patients.

ClinicalTrials.gov has a lot of value and a lot of good intentions behind it, but it turns out that its really easy to take advantage of it and just repurpose it and abuse it as a marketing platform, Turner said.

Unless the site is more closely supervised, he added, There are going to be more people spending money for interventions that arent going to help them in any way, and there will be more people harmed.

FMI: You'll find Turner's paper on Regenerative Medicines website.

Go here to see the original:
Stem-cell clinics are using a federal website as a marketing tool for unproven treatments, U of M bioethicist says - MinnPost

Stem cell therapy isnt approved to treat heart failure in the US, but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the US alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients medical records and just one facility said it had a board certified cardiologist on staff.

We simply do not know anything about the quality of the treatment delivered at these centers, said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

These centers are not regulated in any way, Hauptman said by email.

Almost 6 million Americans have heart failure, and its one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the US Food and Drug Administration.

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasnt involved in the study.

Its also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though theres no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patients own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, If you have a million dollars to spend we will set you up with weekly infusions.

Hauptmans team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you and We hope you dont believe your doctor when they tell you there is nothing they can do, you were smart to call us.

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain, said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasnt involved in the study.

The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure, Sipp said by email.

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasnt involved in the study.

But its impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris, Turner said. Often one can only speculate.

Read more:
More than 60 US clinics have sold unproven stem cell therapies for heart failure - New York Post

Ping Yeh, the leader of the disease-testing company that just won the Minnesota Cup, is a mechanical engineer who decided to shift to health products from electronics after a bout with cancer.

We are just thankful to be part of this entrepreneurial community, Yeh said Friday, a day after his firm, Stemonix, took the grand prize in the states biggest business competition.

The company is improving production, growth and manufacture of human heart and brain cells for drug toxicity and efficacy testing. It already is selling the results to several unspecified pharmaceutical companies, Yeh said.

The graduate of the University of California, San Diego said he started Stemonix in 2014, after recovering from Hodgkins lymphoma that was diagnosed in 2012. After receiving a maximum-toxicity treatment that cured his cancer, Yeh learned the only way to test for heart damage as a result of the treatment was after, not before the treatment. That prompted him to use his knowledge of nanotechnology to start Stemonix.

We sell human minibrains and human heart tissue, samples and human stem cells that are derived from skin or blood or teeth, he said. I want to help cure the toughest diseases of our society. Our technology, in addition to being helpful to drug companies, eventually will help physicians understand the disease and optimal treatments.

Yeh, who earned an MBA from the University of Minnesota, leads a team of 18 employees and consultants at downtown Minneapolis-based Stemonix. He said the company previously has raised about $5 million in equity, mostly from individual angel investors in Minnesota, North Dakota and San Diego. He declined to name drug-company customers or discuss financial projections of fledgling Stemonix.

In August, Stemonix and seven other division winners won $30,000 apiece in seed capital, as the monthslong Minnesota Cup competition progressed to Thursday nights presentation by the eight finalists.

Over the past 12 years more than 11,000 aspiring entrepreneurs have participated in this competition, and gone on to raise more than $225 million to foster innovation and job creation in Minnesota, said Melissa Kjolsing, executive director of Minnesota Cup. The finalists were:

Activated Research Co., in energy/clean tech/water category;

SelfEco Garden in food/ag/beverage;

Berd Spokes in general

Vugo in high-tech;

Stemonix in life science/health IT;

Asiya in social entrepreneurship;

Minnealloy Magnetics in student;

ExpressionMed in youth.

In addition to the grand prize, the Carlson Family Foundation awarded $25,000 to Asiya, the top female-led business.

Meda, the economic-development counselor that nurtures minority-owned businesses, also gave $10,000 to Asiya, as the minority entrepreneur with the most innovative business concept.

A record 1,500 entrepreneurs participated in the Minnesota Cup competition, which this year introduced a youth division for budding entrepreneurs 18 and younger.

A record 38 percent of entries were from female-led teams. More information: mncup.org.

Here is the original post:
Stemonix, a stem cell research firm, wins Minnesota Cup ...

In 2014, Minnesota became the most recent of a handful of states that provide state funding for all types of stem cell research, including human embryonic stem cell research (hESCR).[i]

The law provides for 10 years of funding with $4.5 million approved for the first year and $4.35 million each year thereafter.

Since state funding for stem cell research was approved, Regenerative Medicine Minnesota (RMM), the body established to oversee the approval and distribution of grants, has made two rounds of grants. RMM awarded grants to six research projects in 2015, and to nine in 2016.

Not one of the 15 funded research projects utilized human embryonic stem cells (hESCs).

This is not surprising, given patterns of funding that the Lozier Institute has documented in other states where funding for hESC research is not prohibited (e.g., here and here). The clear pattern over the years in states such as California (the nations largest funder of stem cell research apart from the federal government) and Maryland has clearly trended away from funding hESC research and toward providing overwhelming support for ethically non-contentious adult stem cells and other types of non-embryonic stem cell research.

The Minnesota grants reinforce this trend and are even more revealing for another reason.

Minnesota boasts one of the nations leading programs for stem cell research, the University of Minnesota Medical Schools Minnesota Stem Cell Institute. In fact, this institute, established in 1999, was the nations first interdisciplinary institute dedicated to stem cell research. But despite this first for stem cell research, Minnesota is a relative latecomer in approving state funding.

In contrast, in California voters approved state funding for stem cell research in 2004, leading to the establishment of the California Institute for Regenerative Medicine (CIRM). CIRM distributed its first round of grants in 2007, fairly early on in the then-emerging field of regenerative medicine. Not surprisingly, given all the hype and exaggeration surrounding the promise of human embryonic stem cells, all of the 72 first-round grants awarded were for hESC research. One month later, CIRM awarded another round of grants and again all 29 of them went to hESC research.

Public funding of stem cell research tells a similar story in Maryland. In 2006, that states legislature approved public funding of stem cell research and the first grants were made in 2007 again, fairly early in the field of regenerative medicine. Of the 24 grants awarded that year, only four went to projects focusing solely on non-embryonic, adult stem cell research. Those grants for hESC projects amounted to $5.21 million, more than twice the $2.4 million awarded to adult stem cell research.

In contrast, Minnesotas funding for stem cell research only began in 2015, well past the point when the initial phase of hype and over-inflated expectations for hESC research had subsided. It came after the 2007 discovery of how to create human induced pluripotent stem cells (iPSCs).[ii] Human iPSCs have since come to dominate the pluripotent stem cell focus within the field of regenerative medicine. So important was this development that Shinya Yamanaka, who discovered the method for creating iPSCs, was awarded the Nobel Prize for Medicine in 2012, just five years after his discovery.

Looking at the decision of RMM not to fund any research projects devoted to hESC research, it is fair to conclude that by 2015 and 2016, RMM could see the complete failure of hESC research to live up to its much-hyped promise and thus decided that its citizens money would be better spent on adult and other non-embryonic stem cell research, including research using iPSCs. Almost two decades after human embryonic stem cells were first isolated, there have only been a dozen clinical trials utilizing them. In contrast, the NIH lists thousands of clinical trials for adult stem cells.[iii]

Minnesota may be the most recent state to provide public money for stem cell research. But in declining to fund hESC research in favor of adult stem cells and other ethically non-contentious, non-embryonic stem cell research, it is echoing a trend that has been gathering momentum for years.

Gene Tarne is senior analyst for the Charlotte Lozier Institute.

[i] The other states currently funding all forms of stem cell research including human embryonic stem cell research are California, Connecticut, Maryland, and New York. Programs in Illinois and New Jersey to provide state funding for such research have ended.

[ii] Induced pluripotent stem cells are ordinary somatic cells (such as a skin cell) that have been reprogrammed back to an embryonic-like, fully pluripotent state. These cells were dubbedinduced pluripotent stem cellsas they are created by inducing a somatic cell into becoming a pluripotent stem cell.

[iii]https://www.clinicaltrials.gov/ct2/results?term=adult+stem+cell+transplants&type=Intr

View original post here:
Minnesotas Funding of Stem Cell Research Echoes Trend ...

TY - CHAP

T1 - Stem cell research

AU - Norrander,Barbara

AU - Norrander,Jan

PY - 2007

Y1 - 2007

N2 -

At the 2004 Democratic convention, Ron Reagan, the son of the former president, took the podium to call for increased federal funding for stem cell research. Nancy Reagan also publicly supported stem cell research in the hope that some day this research could help to cure the Alzheimer's disease that had stricken her husband. Meanwhile in California, Republican governor Arnold Schwarzenegger supported Proposition 71, which would provide $3 billion in state aid for stem cell research. Yet despite support from some prominent Republicans, President George W. Bush generally opposed stem cell research due to ethical concerns over the destruction of human embryos. In August 2001 he had limited federal funding for such research to the existing sixty cell lines. In contrast, Democratic presidential nominee John Kerry promised a fourfold increase in federal funding. The question remained whether stem cell research would become a decisive issue in the 2004 election. Various reasons existed to suspect that it would not. Voters were probably less aware of this issue than of more long-standing or common issues, such as the state of the economy. Voters also were receiving mixed signals as to the partisan content of the issue. On the one hand, voters' opinions on the stem cell issue might overlap with other moral issues, such as abortion, causing stem cell opinions to supplement, but not change, existing patterns of political preferences. On the other hand, stem cell research was a debated topic during the campaign, and positions on the issue might not line up directly with attitudes on other moral issues. In investigating these questions, the chapter proceeds as follows. We begin with a brief overview of the science behind stem cell research and then turn to an analysis of whether opinions on stem cells had any impact on the 2004 presidential vote. We conclude with a discussion of whether stem cell research is likely to become the "new abortion"-a long-standing issue that divides the parties. 2007 Royal Institute of International Affairs.

AB -

At the 2004 Democratic convention, Ron Reagan, the son of the former president, took the podium to call for increased federal funding for stem cell research. Nancy Reagan also publicly supported stem cell research in the hope that some day this research could help to cure the Alzheimer's disease that had stricken her husband. Meanwhile in California, Republican governor Arnold Schwarzenegger supported Proposition 71, which would provide $3 billion in state aid for stem cell research. Yet despite support from some prominent Republicans, President George W. Bush generally opposed stem cell research due to ethical concerns over the destruction of human embryos. In August 2001 he had limited federal funding for such research to the existing sixty cell lines. In contrast, Democratic presidential nominee John Kerry promised a fourfold increase in federal funding. The question remained whether stem cell research would become a decisive issue in the 2004 election. Various reasons existed to suspect that it would not. Voters were probably less aware of this issue than of more long-standing or common issues, such as the state of the economy. Voters also were receiving mixed signals as to the partisan content of the issue. On the one hand, voters' opinions on the stem cell issue might overlap with other moral issues, such as abortion, causing stem cell opinions to supplement, but not change, existing patterns of political preferences. On the other hand, stem cell research was a debated topic during the campaign, and positions on the issue might not line up directly with attitudes on other moral issues. In investigating these questions, the chapter proceeds as follows. We begin with a brief overview of the science behind stem cell research and then turn to an analysis of whether opinions on stem cells had any impact on the 2004 presidential vote. We conclude with a discussion of whether stem cell research is likely to become the "new abortion"-a long-standing issue that divides the parties. 2007 Royal Institute of International Affairs.

UR - http://www.scopus.com/inward/record.url?scp=84901178893&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84901178893&partnerID=8YFLogxK

M3 - Chapter

SN - 0815710178

SN - 9780815713272

SP - 142

EP - 159

BT - A Matter of Faith: Religion in the 2004 Presidential Election

PB - Brookings Institution Press

ER -

Read more:
Stem cell research Experts@Minnesota