Kerry Simon returns from first round of stem-cell trials at Mayo Clinic, plans Feb. 27 benefit

David Becker/WireImage

Doug Bell (Heraea), Eric Ripert, Anthony Bourdain, Barry Dakake (N9NE Steakhouse) and Kerry Simon (Simon) at the Palms on Saturday, Feb. 9,2013.

By Robin Leach (contact)

Monday, Feb. 17, 2014 | 6 p.m.

Iron Chef winner Kerry Simon is back home after his first week of stem-cell treatments at the Mayo Clinic. He had an emotional homecoming with his restaurant partner Elizabeth Blau and Europes leading Multiple Systems Atrophy scientist, Dr. Gregor Wenning from Austria, who had been meeting with Kerrys physician, Dr. Ryan Walsh from the downtown Cleveland Clinic Lou Ruvo Center for Brain Health.

Kerry underwent two days of stem-cell injections at the base of his spine that had been harvested from him in a December visit to Mayo in Rochester, Minn. He told me they were exhausting and painful and that his return to Las Vegas over the weekend was delayed a day while fighting a low-grade fever.

It is unknown if the treatments will benefit him in the crippling disease for which there is no cure or treatment. He will return to Minnesota in March for two months of additional stem-cell surgeries and clinical trials.

First up, though, is his celebrity chef fundraiser and rock concert at the Brain Center on Feb. 27. An after-party for the food and music stars will follow at his restaurant Simon in Palms Place. For information and tickets, please go to KeepMemoryAlive.org.

Sammy Hagar, Alice Cooper, Vince Neil and Slash are among the performers, with Oscar-nominated actor and comedian Bill Murray as MC. Jean-Georges Vongerichten, Daniel Boulud and Charlie Palmer are among the 15 guest chefs.

Meantime, the Las Vegas hospitality industry is helping Kerrys fundraiser with auction items that Christian Kohlberg will sell. They include chef dinners from Mario Batali, Thomas Keller and Todd English and celebrity chef restaurant dinners from Guy Fieri, Emeril Lagasse and Wolfgang Puck.

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Kerry Simon returns from first round of stem-cell trials at Mayo Clinic, plans Feb. 27 benefit

Chef Kerry Simon undergoes stem-cell transplants at Mayo Clinic in Minnesota

Erik Kabik/Retna/ErikKabik.com

Kerry Simon and Barry Dakake at Chefs to the Max, a fundraising dinner for food critic Max Jacobson, at Rx Boiler Room on Sunday, Jan. 19, 2014, in MandalayPlace.

By Robin Leach (contact)

Thursday, Feb. 13, 2014 | 2:08 p.m.

Celebrity Iron Chef champion Kerry Simon underwent the first of two days of initial stem-cell transplants at the Mayo Clinic in Minnesota on Wednesday. After todays second set of spinal injections, Kerry will return to Las Vegas on Friday.

Before he returns to Rochester in early March for more intensive sessions of stem-cell transplants, he will preside over his Feb. 27 celebrity chef and rocker showcase at the Keep Memory Alive event center in the Cleveland Clinic Lou Ruvo Center for Brain Health downtown.

Word from Kerry, a 2013 Silver State Award recipient, on Wednesday night was that he was in good spirits, although very tired, resting comfortably and optimistic with the medical procedure. There is no known cure or treatment for Multiple Systems Atrophy (a stronger, more-aggressive form of Parkinsons) hes fighting that we reported in December.

On Friday, he meets here with 20 volunteers who formed a committee to organize the Feb. 27 events. His good pal comedy actor Bill Murray will serve as MC, and Christian Kohlberg will join him as auctioneer.

Before he underwent surgery, Kerry told me this week: I cannot believe the support we are getting for our Fight MSA campaign. It is unbelievable. I am deeply touched by all these wonderful people helping out at the drop of a hat with nothing more in mind than to conquer this terrible disease.

Im not going to let it stop me doing what I must do.

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Chef Kerry Simon undergoes stem-cell transplants at Mayo Clinic in Minnesota

Stem cell clinic for 4 year old

Cambridge Times

CAMBRIDGE The courageous fight of four-year-old Katie Herron is continuing at Torontos SickKids where she continues to undergo chemotherapy in hopes that a stem cell match can be found for a life-saving transplant.

Here in Cambridge, friends and family members are spreading the message for Katies Kure, in preparation for a stem cell donor clinic next Saturday, Feb. 22, at the Cambridge Sports Park.

There are now over 1,000 people going on our Facebook page (Katies Kure) with a great number of people registering online with onematch.ca that are unable to attend the actual donor drive, said her mother, Anne Hodgkinson, in an email.

We are absolutely overwhelmed with the support we are receiving from the community. Support not just for Katie and our family, but support in helping us get the information on stem cell donation out there.

Parents at Coronation Public School where Katie started junior kindergarten in September have distributed flyers across the city along with pink and green stars. Green represents stem cell donation and pink, Katies favourite colour, represents her journey.

Katie enjoys seeing pictures of all the stars put up around Cambridge, and it is a wonderful feeling for her to know that there are so many people thinking and praying for her back home, her mother says.

The youngsters mettle has been tested in recent weeks.

Last Thursday, she and her family were still in Hamilton at McMaster Childrens Hospital awaiting an MRI and other sedated testing for a critical bacterial infection shes fighting. Just after 11 a.m., they were given the news that SickKids had a bed available and Katie would be moved that day.

According to her mother, the whole ordeal has left Katie fragile, emotionally as well as physically. Shes still on a feeding tube, unable to walk, but is now undergoing physiotherapy, hoping to get her dancing feet back.

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Stem cell clinic for 4 year old

Scientists discover pre-leukemic stem cell at root of cancer

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Dr. John Dick, a senior scientist at Princess Margaret Cancer Centre in Toronto, is shown in a handout photo.

TORONTO Canadian researchers have discovered a pre-leukemic stem cell that may be at the root of acute myeloid leukemia and also be the bad actor that evades chemotherapy and triggers a relapse in patients who have gone into remission.

Acute myeloid leukemia, or AML, is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into mature red and white blood cells and platelets.

Leukemia develops when blood stem cells in the bone marrow make abnormal blood cells, which over time crowd out normal blood cells, affecting their ability to function as they should.

READ MORE:Could this new therapy kill cancer? Canadian doc thinks so

In a paper published online Wednesday in the journal Nature, researchers led by John Dick of Princess Margaret Cancer Centre in Toronto report on the discovery of a pre-leukemic stem cell the forerunner to leukemia stem cells that give rise to the disease.

A leukemia stem cell can lie dormant and theyre the ones that will sustain the growth of the leukemia, Dick said in an interview. The pre-leukemic guys are basically the ancestors that are on their way to becoming leukemia and becoming leukemic stem cells.

Dicks lab was the first to identify the existence of leukemia stem cells, in 1994, followed by the discovery of colon cancer stem cells in 2007.

Teasing out pre-leukemic stem cells from the blood of AML patients based on samples taken at diagnosis, after chemotherapy-induced remission, and then following recurrence advances the understanding of the genetic changes a normal cell has to go through before it turns into AML.

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Scientists discover pre-leukemic stem cell at root of cancer

Top Henderson Pain Management Clinic, Nevada Pain, Now Offering Over 25 Effective Pain Treatments

Henderson, NV (PRWEB) February 12, 2014

The top pain management clinic in Henderson, Nevada Pain, is now offering over 25 effective pain treatments. The options include both medical and interventional pain management, chiropractic, physical therapy, spinal decompression therapy, stem cell treatments and acupuncture. Call (702) 323-0553 for more information and scheduling.

Nevada Pain's Board Certified team provides patients with customized options for treatment with comprehensive options. With over a third of Americans suffering from chronic pain, it is vital to have extensive options for achieving relief. With over 25 options to choose from, the success rate at Nevada Pain for avoiding surgery and providing patients relief is over 95%!

Treatments include both medical and interventional with oral or topical NSAIDS, neuropathic medicines, pain medication, muscle relaxers and more. Several types of epidural injections are provided: radiofrequency ablation, spinal cord stimulator implants, stem cell injections and all types of joint injections.

Chiropractic and physical therapy is offered in addition to spinal decompression therapy and acupuncture. The combination of traditional and alternative Las Vegas pain management therapies provides an excellent chance for the best patient success.

Both simple and complex conditions are treated such as arthritis, sciatica, spinal stenosis, scoliosis, fibromyalgia, headaches, migraines, neuropathy, degenerative disc disease and failed back or neck surgery. Nevada Pain does not believe in a "one size fits all" approach.

For more information and scheduling with pain management Henderson NV trusts, call (702) 323-0553.

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Top Henderson Pain Management Clinic, Nevada Pain, Now Offering Over 25 Effective Pain Treatments

Two Oncogenes Join to Drive Lung Squamous Cell Carcinoma

Released: 2/10/2014 12:00 PM EST Source Newsroom: Mayo Clinic Contact Information

Available for logged-in reporters only

Newswise JACKSONVILLE, Fla. Patients with a common form of lung cancer lung squamous cell carcinoma have very few treatment options. That situation may soon change.

A team of cancer biologists at Mayo Clinic in Florida is reporting in the Feb. 10 issue of Cancer Cell the discovery of two oncogenes that work together to sustain a population of cells in lung squamous cell carcinoma, which may be responsible for the lethality of the disease. When these cells, termed cancer stem cells, are inhibited, tumors cannot develop.

MULTIMEDIA ALERT: Video and audio are available for download on the Mayo Clinic News Network.

Cancer stem cells are a small population of cells in a tumor that can self-renew and grow indefinitely. They resist most treatments and are thought to be responsible for relapse, says the studys senior author, Alan P. Fields, Ph.D., the Monica Flynn Jacoby Professor of Cancer Studies at Mayo Clinic in Florida.

If you can shut down cancer stem cells, you may be able to stop relapse after therapy, he says.

The study, which is featured on the cover of Cancer Cell, builds upon years of research by Dr. Fields and his colleagues on a cancer-causing gene protein kinase C iota (PKCiota). They were the first to discover the connection between PKCiota and initiation, promotion and spread of lung cancers, including lung squamous cell carcinoma, which accounts for 3040 percent of all lung cancer. The researchers found that the PKCiota gene is errantly repeated numerous times in lung squamous cell carcinoma cells through a genetic alteration termed gene amplification. PKCiota gene amplificationis associated with poor patient survival. Subsequently, they discovered that PKCiota is necessary to maintain cancer stem cells in these tumors, but how it did that was not clear.

The newly released study defines the process. The researchers discovered that PKCiota and a second oncogene, SOX2, found in the same region of chromosome 3 known as 3q26, are coordinately amplified and overexpressed in a majority of lung squamous cell carcinomas. The study further shows that these two oncogenes are also functionally linked in these tumors.

We now know that PKCiota activates SOX2, meaning that these two genes are not just genetically linked by amplification, but also biochemically and functionally linked in promoting lung squamous cell carcinoma, says the studys lead author, Verline Justilien, Ph.D., an instructor of cancer biology at Mayo Clinic in Florida.

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Two Oncogenes Join to Drive Lung Squamous Cell Carcinoma

D.C. circuit rules FDA can regulate autologous stem cells

By William T. Koustas

The litigation between Regenerative Sciences, LLC (Regenerative) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority to regulate certain autologous stem cells procedures. The D.C. Circuit affirmed the lower courts decision granting summary judgment to the government, dismissing Regeneratives counterclaims, and permanently enjoining Regeneratives operations.

Regenerative is a Colorado company that owns a medical technique known as the Regenexx Procedure, a non-surgical procedure by which physicians take bone marrow and blood samples from a patient, culture the stem cells, mix the cultured cells with doxycycline, and inject the stem cell mixture back into the same patient in order to treat joint, muscle, tendon, or bone pain. The Regenexx Procedure is exclusively licensed for use by a Colorado clinic where its inventors practice.

Our prior blog posts on this case provide more background (see here andhere for example), but in essence, FDAs litigation stance was that the stem cell mixture used in the Regenexx Procedure was a drug under the Federal Food, Drug, and Cosmetic Act (FDCA), thus imposing current Good Manufacturing Practices (cGMP) and labeling requirements applicable to all drugs. On the other side, Regenerative argued that FDA had no authority over the Regenexx Procedure because it involved the practice of medicine, which is outside of FDAs purview, and because the stem cell mixture was not introduced or delivered for introduction into interstate commerce.

The D.C. Circuit upheld the district courts decision, frequently relying on long-standing principles of food and drug law. The court first found that the stem cell mixture met the definition of drug contained in the FDCA as it was an article derived mainly from human tissue intended to treat orthopedic diseases and to affect musculoskeletal function. Slip Op. at 6. In addition, and perhaps of more consequence, the court disagreed with Regeneratives argument that FDA was interfering with the practice of medicine by preventing physicians from performing autologous stem cell procedures. The D.C. Circuit described this argument as wide of the mark, clarifying that FDA was seeking to regulate the stem cell mixture and not the procedure itself. Id. at 7.

The court also rejected Regeneratives argument that FDA lacked jurisdiction over the stem cell mixture given that the Regenexx Procedure is performed entirely within the State of Colorado. Unsurprisingly, the court restated the well-known principle that the interstate commerce requirement of the FDCA is satisfied if a component of a product is shipped in interstate commerce prior to its administration to a patient. Id. at 9. The court also seemed to agree with FDAs position that the interstate commerce requirement could be satisfied simply because the stem cell mixture would undoubtedly have effects on interstate markets for orthopedic care . . . . Id. at 8.

The D.C. Circuit also dismissed Regeneratives argument that the stem cell mixture was a human cell, tissue, or cellular and tissue-based product (HCT/P), and thus exempt from manufacturing and labeling requirements. The court found that the stem cell mixture was likely more than minimally manipulated [b]ecause [Regenerative] concede[d] that culturing [stem cells] affects their characteristics and offer[ed] no evidence that those effects constitute only minimal manipulation, they fail to carry that burden as a matter of law. Id. at 12.

After summarily rejecting Regeneratives arguments, the D.C. Circuit ruled that the stem cell mixture was adulterated and misbranded. The court found that the stem cell mixture was adulterated because it was not manufactured in conformance with cGMP requirements, and that they were misbranded because the information on the label on the syringe that contains the stem cell mixture did not include adequate directions for use or bear the Rx only symbol. Id. at 14-15.

Although the court upheld the permanent injunction, it did so only after analyzing whether there was a reasonable likelihood of further violations in the future. Id. at 18. While the court determined that such likelihood existed in this case, this suggests that a violation of the FDCA, in and of itself, does not automatically necessitate injunctive relief but must be considered based on the facts of each case.

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D.C. circuit rules FDA can regulate autologous stem cells

Stem Cell Clinic

With Focus on Adult Stem Cells to Treat Chronic Degenerative Diseases The Stem Cell Clinic is a multi-institutional center, dedicated to ensuring an uncompromising level of quality care.

Dr. Francisco Contreras, an extensively trained oncologist and surgeon, leads the Stem Cell Clinic in its effort to providing safe and effective regenerative therapies including the use of adult stem cell treatments, nutrition and immune building protocols.

Learn More...

The Stem Cell Clinic advocates and practices the use of adult stem cells, as there are no ethical or moral issues related to their use as compared to embryonic stem cells. There are also more successful treatments confirmed with the use of adult stem cells over embryonic.

Dr. Francisco Contreras demonstrates the procedure to harvest stem cells from the bone marrow.

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If you are searching for experienced surgeons that can provide the treatment and care you deserve, contact the Stem Cell Clinic today. Our clinic provides the highest quality of support to patients from around the world. If you would like to schedule a consultation, please fill out our request form, and a member of our staff will contact you shortly.

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Stem Cell Clinic

Arizona Pain Announces Positive Results in Revolutionary Stem Cell Study on Chronic Low Back Pain

Scottsdale, AZ. (PRWEB) February 03, 2014

The team at Arizona Pain (arizonapain.com), has received approval to announce the much anticipated Phase II results of a potential medical breakthrough on the use of stem cells for chronic low back pain. The study, which first garnered international attention two years ago as one of the first trials of its kind in the U.S., has produced positive, promising results.

"We are pleased to report that a clinical study has indicated that a single injection of adult, donor marrow stem cells into degenerating intervertebral discs has reduced low back pain and improved function in trial participants for at least 12 months, says Dr. Paul Lynch, M.D., Arizona Pain Co-Founder and double-board certified Pain Management physician. The results of this study, if confirmed, could change the way we treat low back pain.

Arizona Pain was the first clinic in the U.S. to have been selected for an FDA-cleared study on this advanced treatment. Since then, 100 qualified patients were offered an opportunity to participate in a controlled, double-blind study that monitored any changes in the patients degenerative lumbar discs throughout the trial. The stem cells were taken from the bone marrow of a young healthy adult donor, were culture expanded and were administered through a minimally invasive, single injection. Trial participants remained unaware of whether or not they received injections with stem cells or one of the control treatments.

Key findings at 12 months in the trial were reported as follows: improvement in chronic low back pain with reduction in mean pain score; increased proportion of patients achieving 50% reduction in pain score; increased proportion of patients achieving minimal residual back pain; reduced opioid use for pain relief; and reduced need for additional surgical and non-surgical interventions for persistent pain.

Arizona Pain is incredibly proud to have partnered with the trial sponsor Mesoblast, a world leader in regenerative medicine (http://www.mesoblast.com) on this sentinel research study, says Dr. Lynch. The results are promising and we are hopeful that these findings will be confirmed in a Phase III trial beginning this year."

On January 29, 2014, Mesoblast announced positive 12 month outcome results from the 100-patient Phase II clinical trial of its proprietary allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs) in patients with chronic moderate to severe discogenic low back pain. The results showed that a single injection of MPCs into degenerating intervertebral discs reduced low back pain and improved function for at least 12 months. When compared with controls, MPC-treated patients used less opioids for pain relief, had greater radiographically-determined disc stability, and underwent less additional surgical and non-surgical treatment interventions. MPC treatments also appeared to be well tolerated during the study.

Mesoblast Chief Executive Silviu Itescu said, On the basis of these positive results, Mesoblast plans to meet shortly with regulatory authorities in major jurisdictions, including the United States Food and Drug Administration, to discuss product registration trials for the potential treatment of disc degeneration."

More than 6 million patients in the United States alone are currently dealing with chronic back pain that has persisted for at least three months, with around 3.5 million people affected by moderate or severe degenerative intervertebral disc disease. The United States Centers for Disease Control and Preventions National Center for Health Statistics reported in 2010 that low back pain was the leading cause of pain, affecting 28% of American adults, and the second most common cause of disability in American adults.

This study shows we are progressing toward major advances in pain medicine, says Dr. Tory McJunkin, M.D., co-founder of Arizona Pain and PainDoctor.com. Stem cell therapy focuses on addressing the source of the pain, rather than just the symptoms. We truly hope this will unlock a vital solution for people suffering from debilitating low back pain, says Dr. McJunkin.

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Arizona Pain Announces Positive Results in Revolutionary Stem Cell Study on Chronic Low Back Pain

More Stem Cell Clinic Hype Press Releases for the New Year …

This week I saw yet another crazy press release. I usually see these from some university claiming a stem cell first that isnt close to a first. Yet now they also seem to be coming from doctors who are claiming firsts that are no where near firsts. This one was from an Orthopedic Sports doctor who claims to be the only orthopedic surgeon in the country using stem cells (we have a few in our network and bone marrow stem cells have been in common use by surgeons for at least a decade). The story was so riddled with inaccuracies (stem cells coming from blood, stem cells not being common practice because of the Bush Embryonic stem cell ban, that there is something unique about a little bedside centrifuge processing bone marrow), that I thought it was time to again differentiate what we do from the wild west of stem cell clinics cropping up.

When we first pioneered orthopedic stem cell therapy in 2005, we were the only physicians in the U.S. doing this type of work. This last few years has seen a bevy of clinics opening up and offering stem cell therapies for pretty much whatever ails you-from arthritis to ALS to COPD to MS. A few of these clinics are legitimately trying to do a good job, but most are not. How can you tell the difference? First, lets look at the clinic types that are popping up:

The Miracle Fat Stem Cell Clinic-These clinics offer treatments for a multitude of diseases that include knee and hip arthritis. They perform a small liposuction to get cells and as such, are usually run by a plastic surgeon who oversees a processing facility that distributes cells to other medical specialists. Some claim to be operating research studies, but when I have investigated these further, most of this is more sales than reality (i.e. one clinic system claimed to have a research IRB approval that turned out to have been rescinded). In addition, on the orthopedics side of the treatments, these are usually blind non-specific injections (without any guidance to ensure accurate placement) somewhere in the vicinity of the painful joint. They frequently will combine these local injections with an IV infusion of fat stem cells, 97% of which will end up in the lungs and never see the joint. As you know from previous blogs, fat stem cells dont work as well as marrow cells for orthopedic purposes, so the orthopedic side of the business seems to be an afterthought to drive revenue.

The Little Bedside Machine Clinic-These clinics are often more focused on orthopedic problems, but use an automated bedside one size fits all machine to process bone marrow cells and platelet rich plasma. Some of these clinics do offer guidance of the injection, but very little effort is placed on tracking patients or reporting outcome data. So the type of treatment registry data that youve read about on this site over the past month isnt going to be reported by these clinics, leaving the patient to fly blind on how well these procedures work or dont work. These machines also produce about 1/10-1/15th of the stem cells per unit volume as a Regenexx-SD procedure (based on our lab studies). They also only isolate one fraction in the bone marrow that contains stem cells and discard the other fraction (not knowing that it has valuable cells).

So what key components should a clinic have so you can feel comfortable?

Treatment Registry Tracking of Patients

Any new therapy that is yet standard of care needs to have data collected, even if it looks very promising from the standpoint of patient experience (i.e. a doctor says it has worked well in other patients). This means that standardized questionnaires are sent to the patient at set time points to see if they have less pain, more function, or had any complications with the procedure. This is a huge commitment on the part of the clinic and the doctor. As an example, right now we have a Clinical Research organization quality customized software to assist us in collecting data on the patients weve treated. We have two full-time employees to collect data, several part time supervisors, and a full time bio statistician to analyze this data. When we want to report the data, we must enlist the help of expensive physicians to call patients who havent responded to their questionnaires as this helps to make sure we have enough data to report. While we have a bio statistician, we must then use more expensive doctor time to help him decide whats clinically meaningful to analyze.

How can you tell if a clinic is doing this? They will have data from their patients that they have collected and reported, usually on an annual basis. As an example, the clinic mentioned above with the little bedside centrifuge that claimed magic, had no data and just began doing this procedure, so you wouldnt expect there to be any. Why is it important to see that clinics data? A procedure like this may produce very different results in a different doctors hands. In addition, the clinic will be able to tell you exactly how it collects its data, who collects it, how often, etc For example, a proper treatment registry collects data at set time points like 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, etc If all you get is a call from a nurse like you would after any common surgery, then this isnt nearly enough.

Guidance of the Injection

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More Stem Cell Clinic Hype Press Releases for the New Year ...