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Cameron Mathison Is Undergoing Stem Cell Treatments - Soaps In Depth

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Cameron Mathison Is Undergoing Stem Cell Treatments

A federal judge in Riverside declared a California stem cell treatment firm to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous.

In the ruling issued late Tuesday, Judge Jesus G. Bernal of Riverside declined to block California Stem Cell Treatment Center from continuing to offer purported stem cell treatments to customers.

Bernal accepted the centers position that its treatments qualified for an exception from FDA regulations, in part because they were tantamount to surgical procedures.

Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype.

Food and Drug Administration warns public against unproven stem cell treatments

Bernals ruling, which came more than a year after a seven-day trial in May 2021 and closing arguments last August, potentially undermines a years-long FDA crackdown on clinics claiming that stem cells can treat or cure conditions including orthopedic injuries, Alzheimers and Parkinsons diseases, multiple sclerosis, and erectile dysfunction.

The defendants are engaged in the practice of medicine, Bernal ruled, not the manufacture of pharmaceuticals.

The FDA regulations, however, define drugs much more broadly than the manufacture of pharmaceuticals rather, as any article that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Any such articles, the agency says, must have agency approval and the California centers treatments do not.

To me, the language of his ruling sounded almost like it was written by the defendants, Paul S. Knoepfler, a UC Davis stem cell biologist who has been tracking the proliferation of such clinics for years, observed in his laboratory blog.

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The Bernal ruling will not be a good thing for careful oversight of stem cell clinic practices, Knoepfler said. Its concerning to think about more people being put at risk.

Knoepfler suggested that the FDA would feel duty-bound to appeal Bernals ruling in order to protect its regulatory campaign, and because it conflicts with federal court rulings in a nearly identical case the FDA brought against Florida clinics in Miami federal court.

The agency told me by email that it is reviewing the courts decision and does not have further comment at this time.

Bioethicist Leigh Turner of UC Irvine, who has collaborated with Knoepfler on tracking the growth of the stem cell clinic industry, agreed that Bernals ruling is an enormous setback for the FDA in an area where theyve struggled for many years.... For people who work in this industry, its great news. But not for anyone concerned about patient safety, misinformation or disinformation.

As part of its crackdown, the FDA has written hundreds of letters warning stem cell clinics that theyre violating the law, and has pursued some in court.

After issuing regulations in 2017 declaring that treatments using unproven stem cell therapies were illegal, the FDA suspended its enforcement for more than three years to give clinic operators time to comply with FDA rules. The agencys forbearance, however, opened the door to a further proliferation of suspect clinics.

By March 2021, according to a survey by Turner, nearly 1,500 U.S. businesses were pitching the suspect treatments at more than 2,700 clinics, reflecting a torrent of openings since 2016, when Turner and Knoepfler jointly started tracking the field.

More than four times as many businesses than were identified five years ago are selling stem cell products that are not FDA-approved and lack convincing evidence of safety and efficacy, Turner wrote last year.

Some clinics have charged customers more than $10,000 for the unproven treatments, plying the customers with unsupported claims of medical success. The fees are seldom, if ever, covered by health insurance. Some treatments resulted in serious medical complications.

The FDA also has warned the public that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful.

The FDA has approved stem cell treatments only for disorders of the blood-producing, or hematopoietic, system. No other stem cell treatment claims have been scientifically validated, the agency says.

Stem cells have been called everything from cure-alls to miracle treatments, the agency says in its public warning. But dont believe the hype.

Bernals ruling conflicts with a 2019 decision by U.S. District Judge Ursula Ungaro of Miami, who ordered a Florida clinic shut down after the FDA asserted that its purported stem cell therapies were scientifically unproven and illegal.

Ungaros decision was upheld last year by the 11th Circuit U.S. Court of Appeals, which found that the clinics claim of exemption from FDA regulation on grounds similar to those claimed by the California center, didnt apply. No reasonable fact-finder could disagree, the three-judge appellate panel ruled.

As it happens, in its finding the appellate panel specifically rejected an earlier ruling by Bernal, in which he denied the FDAs request for a preliminary injunction against the California center and set the case for trial. The appellate ruling isnt binding precedent for federal courts outside the 11th Circuit, which covers parts of the Southeast.

The FDAs lawsuits against the Florida clinic and the California center were almost identical and filed on the same day, May 9, 2018. In both cases, the agency asserted that the clinics were in effect purveying illegal drugs as defined by federal law.

The lawsuits were part of an agency effort to clamp down on the burgeoning trade in stem cell-related therapies. The California lawsuit named the centers founders, Elliott Lander and Mark Berman, as defendants. Berman died in April

The California Stem Cell Treatment Center has operated clinics in Beverly Hills and Rancho Mirage, and provides treatment protocols and other assistance to other clinics around the country.

In its Florida and California lawsuits, the FDA targeted a widespread practice utilized by both clinics in which fat cells are extracted from a customer by liposuction. The extraction is treated to produce a fluid purportedly rich in stem cells known as a stromal vascular fraction or SVF, which is injected back into the same subject.

Both sets of defendants asserted in their defense that their activities qualified for exceptions from FDA drug regulations afforded to surgical procedures involving the use of a patients own tissues as well as the use of minimally manipulated tissues. The agencys position is that the fat extractions are so heavily treated before the reinjections that the treatments fall outside those exceptions.

In his ruling, Bernal drew extensively and verbatim from California Stem Cell Treatment Centers proposed findings of facts and scarcely at all from the FDAs proposal. His ruling incorporated several scientific errors, according to Knoepfler.

For example, Bernal accepted the centers assertion that unlike manufactured drugs, the SVF Surgical Procedure does not create any cellular or tissue-based product that did not previously exist within the patient.

In fact, Knoepler says, there is no equivalent of SVF already in the body.

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Hiltzik: A judge undermines the FDA on stem cells - Los Angeles Times

NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Companys complete response to the FDA. Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

The submission summarizes controlled data providing further evidence of remestemcel-Ls ability to save lives, said Dr. Silviu Itescu, Chief Executive of Mesoblast. Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.

About Steroid-refractory Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, including about 20% in pediatric patients.4,5 SR-aGVHD is associated with mortality as high as 90% and significant extended hospital stay costs.6,7 There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About Mesoblast Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including BLA resubmission), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For more information, please contact:

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Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD - GlobeNewswire

Newswise LOS ANGELES (Oct. 3, 2022) --Pioneering heart care is a tradition at Cedars-Sinai. Its a tradition that took root in 1924, when Cedars-Sinai became home to the first electrocardiogram machine in Los Angeles.

The roots grew stronger in the 1970s, when two Cedars-Sinai cardiologists invented the game-changing Swan-Ganz catheter. And stronger still in 2007, when Cedars-Sinai founded what is today theSmidt Heart Institute.

On the occasion of the institutes 15thanniversary, the Cedars-Sinai Newsroom sat down withEduardo Marbn, MD, PhD, executivedirector of theSmidt Heart Institute and the Mark Siegel Family Foundation Distinguished Professor, to get his views on the state of cardiac medicine.

Newsroom: What are the advances youve seen in heart medicine over the past 15 years?Marbn:We've been able to really address programs from the point of view of the need of the patient. One thing we've excelled at, for example, is helping our patients with advanced heart diseaseheart failure so severe that they're facing either highly experimental stem cell treatments or heart transplantation. And these are two areas in which we've excelled, become the world leader in the number and also in the outcomes of heart transplants for those patients who need them. And we've also made quite a lot of progress in the area of regenerative medicine.

When the Heart Institute was established 15 years ago, almost all valvular problems in the heart or major structural problems required opening the chest surgically. Putting a patient on cardiopulmonary bypass. Fixing the problem in an operating room. And then keeping the patient in the hospital for about a week. In the past 15 years, the management of valvular heart disease has been completely transformed so that things that used to take that long and were that complicated can now be done as overnight therapy, using just a catheter inside the heart, and no opening of the chest.

We've led the way in the development of these technologies. We've done more such procedures than any other center in the United States.

Newsroom: How much has the Smidt Heart Institute grown?Marbn:Over the last 15 years, the Heart Institute has seen an incredible increase in volume. We have gone from doing 25 thoracic transplants a year, meaning either lung or heart or both, to doing over 200 now, with outstanding outcomes. We have gone from doing about 3,000 catheter-based procedures a year, to 13,000 a year.

We have gone up in our U.S. News and World Report (Best Hospitals) ranking nationally, from #17 Heart Program and #5 in the western U.S. to now being #1 in the western U.S. for the past 10 years and to being the third-ranked program nationally for the last four years.

Newsroom: Also during that time, theBarbra Streisand Womens Heart Centerin the Smidt Heart Institute has pioneered a lot of work on sex differences in heart disease.Marbn:The Smidt Heart Institute has come to be known as the world leader in a number of areas. One of those is in women's heart disease. In the last 15 years, we've really become recognized as a go-to destination for teaching, research and training. We've trained generations of researchers and physicians who are going into this field, and we've discovered that women are not the same as men and the way they manifest their heart disease. Nor are the treatments necessarily likely to work equally in men and in women.

Newsroom: What lessons were learned from the COVID-19 pandemic?Marbn:When the pandemic of COVID-19 started early in 2020, we were among the first to codify the cardiac complications that are associated with the disease. For example, myocarditis and other forms of acute manifestations and the long-running complications that have to do with long COVID. We were among the first to describe these situations. And since then, we've been at the forefront of studying the cardiac complications of COVID-19 in communities.

For example, we have a large ongoing study looking at a large number of community-based participants that then develop COVID-19 and some of whom go on to develop heart disease. We're asking questions like, how does the heart disease manifest itself? Who's at highest risk? What can we do about it? And of course, we're in the data collection stage more than in the answer formulation stage, but we've really tried to get ahead of it rather than just being observers.

Newsroom: What kind of progress do you expect in the next 15 years?Marbn:It's mind boggling to imagine what might happen over the next 15. But for sure, among the trends that we've seen there will continue miniaturization. We believe that it's very likely that major equipment that is now required, for example, to sustain the heart artificiallyluggage sized pumps that need to be plugged in periodically to batteriesfor example, as an external pump for the heart. These things will be miniaturized and implanted.

We're going to see an enormous rise in the maturation and ability of biological therapies, gene-based and cell-based therapies, to address heart disease in a very fundamental way that actually changes the disease rather than just reacts to it. And of course, we're getting better at prevention and also the understanding of how disease is manifested differently in men and in women, as well as in various socioeconomic groups.

Newsroom: Is there a single achievement of which you are most proud?Marbn:The signature accomplishment of the Smidt Heart Institute has been proof of principle that by bringing together diverse specialists from different backgrounds into one setting, that we can improve patient care and our understanding of disease. What we've done here is created a model for how cardiology and cardiac surgery should work together to transform the care and the knowledge about illness as we move forward.

Read more on the Cedars-Sinai Blog:Matters of the Heart: C. Noel Bairey Merz, MD

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15 Years of Heart - Newswise

Houston, TX - (NewMediaWire) - October 03, 2022 - Joint pain is one of the leading causes of discomfort among the American populace. It is estimated that more than 65 million American adults suffer from low back pain, while over 16 million deal with acute or chronic joint pain due to arthritis. The number seems to be growing at an alarming rate annually, with the problem spreading to more young adults due to their lifestyle choices, occupation, accidents, and other reasons. QC Kinetix (The Heights) estimates that a whopping number of Americans will be battling chronic joint pain in years to come if no real step is taken.

As a pain control clinic focusing on health and wellness, QC Kinetix (The Heights) understands the health problems associated with heavy medication use to combat joint pain. The lead treatment provider at the clinic noted that more people who depend on medication for pain relief are growing tired and abandoning it because of its negative side effects on their bodies and organs. Others are too scared to consider surgical interventions which offer no real promises of long-term health benefits.

In the face of these health challenges, QC Kinetix (The Heights) is offering a better solution with better healing potential to patients suffering from joint pain and related problems. Speaking on their natural treatment therapies, the clinic's spokesperson maintained that they offer a minimally invasive and natural treatment solution that helps patients avoid the costs, risks, and complications associated with surgeries. He added that their treatment plan is also devoid of medication use, which means patients can significantly dump the unhealthy habit of medication consumption while improving their health and wellness through other natural means.

The clinic's spokesperson noted that their sports and regenerative medicine treatment focuses on each patient's challenges and finds a way to improve their body's natural healing abilities. Speaking on the treatment modality's effectiveness for Houston Heights back pain treatment, Scott Hoots said: "In our QC Kinetix The Heights regenerative medicine clinics, we serve our patients by providing leading regenerative therapies that reduce joint pain associated with direct trauma, a sports-related injury, or a degenerative medical condition. These techniques target the impacted area to reduce inflammation and repair damaged tissue. Our team of medical professionals receives the highest quality training and research to provide our clients with the latest therapies to alleviate their ailments. In addition, we pride ourselves on providing the highest level of respect and care for our clients, as returning their ability to live with pain relief is our primary goal."

Each patient coming into the clinic will have access to a personalized health and wellness service centered around their needs. The treatment providers offer an initial consultation service where they get to learn more about the patient's health, symptoms, past treatments, allergies, and other information. Patients will also have access to a comprehensive examination and physical assessment for diagnostic purposes. Once diagnosed, the team will determine the patient's suitability for the treatment and develop a personalized treatment plan to alleviate their pain and discomfort while equipping the body with the needed building blocks for long-term health and wellness.

Welcoming Houston residents to schedule an appointment, the lead treatment provider at the clinic noted that regenerative medicine offers a wide range of benefits to patients. He maintained that several of their patients have been able to save money and avoid the complications of surgical intervention through their natural treatment plans. He further noted that their minimally invasive treatments are low risks and require a shorter recovery time compared to surgeries. Using stem cell therapy, platelet-rich plasma therapy, Class IV laser therapy, and others, patients will also enjoy positive health benefits like reduced inflammation, pain relief, improved healing, and a better range of motion from the affected joints.

QC Kinetix (The Heights) is currently taking new patients as its appointment slots are filling up fast. The pain control clinic can be reached via phone at (713) 913-5285 or via its website. The clinic is located at 1900 North Loop West, Suite 300, Houston, TX, 77018, US.

Media Contact:

Company Name: QC Kinetix (The Heights)

Contact Person: Scott Hoots

Phone: (713) 913-5285

Address: 1900 North Loop West, Suite 300

City: Houston

State: TX

Postal Code: 77018

Country: USA

Website: https://qckinetix.com/houston/the-heights/

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QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine - Yahoo Finance

Minnesota Timberwolves star Karl-Anthony Towns was hospitalized last week with a throat infection that caused him trouble breathing and forced him to be on bed rest for days, sources told ESPN.

Towns spoke to the media Monday for the first time since falling ill and said his weight was down to 231 pounds (he's listed at 248), but he didn't reveal the nature of the non-COVID-19 illness.

Towns, who missed all of the Timberwolves' training camp, said he didn't get clearance to walk again until Saturday, when he attended a team event.

ESPN's countdown of the league's best players returns for its 12th season. See which stars made the cut, which vaulted to the top and which are sliding down the list.

NBArank 1-5: International stars on the rise NBArank 6-10: How far LeBron and KD fell NBArank 11-25: L.A. duo and rising Wolves NBArank 26-100: Russ, Ben and a host of Qs Debate! LeBron's ranking and top-10 tweaks

"I'm still recovering. I'm still getting better," Towns told reporters in Minneapolis before the team left on a 10-day preseason road trip. "There was more drastic things to worry about than basketball [during the illness]."

Timberwolves coach Chris Finch said Monday that Towns wouldn't play in Tuesday's preseason opener against the Heat in Miami as he works on ramping up his conditioning. During the offseason, Towns had stem-cell treatments and platelet-rich plasma injections in both knees, his left ankle, left wrist and right finger. He also signed a four-year, $224 million contract extension, tying him to the team for the next five seasons.

Towns averaged 24.6 points, 9.8 rebounds and shot 41% on 3-pointers last season, when he was named to the All-NBA team.

ESPN Reporter Ramona Shelburne contributed to this story

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Sources - Minnesota Timberwolves' Karl-Anthony Towns was on bed rest for days due to throat infection - ESPN