This month MyChelle will be available at Kohl's stores and Kohls.com with a key assortment of cleansers, exfoliators, serums, moisturizers, and sun protection, and a focus on their innovative, professional-level ingredient pillars of Vitamin C and Vitamin Aunmatched in the natural product channel. The brand's award-winning products are formulated with bioactive, clinically-proven ingredients that won't compromise personal health or the wellbeing of the environment.

MyChelle Ingredient Integrity and Transparency

Since its founding in 2000, MyChelle has been committed to full transparency when it comes to the botanicals and high-performance ingredients it uses in its products. The company is a proud founding member of the EWG VERIFIED: For Your Health program to help consumers quickly and easily identify personal care products that are formulated without potentially hazardous ingredients, fully disclose all ingredients, and are created following good manufacturing practices.

The MyChelle Beauty Key 3

Formulated with the top 3 dermatologist-recommended ingredients, the MyChelle Beauty Key 3 integrates a powerful combination of peptides, plant stem cells, antioxidants, and retinoids to perfect, correct, and protect all skin types.

1. C the Difference with L-Ascorbic Acid

The only active form of Vitamin C, L-Ascorbic Acid enhances skin's natural renewal process, protects skin against environmental damage, reduces the appearance of dark spots, and helps to improve the look of acne scarring. The MyChelle Perfect C system includes Perfect C PRO Serum, Perfect C PRO Speed Peel, Perfect C Radiance Lotion, and Perfect C Eye Cream.

2. Remarkable Results with Retinal

The most potent non-prescription form of Vitamin A, Retinal promotes healthy skin renewal and helps minimize the appearance of fine lines, wrinkles, and hyperpigmentation by accelerating cellular turnover. The MyChelle Remarkable Retinal system includes Remarkable Retinal Serum, Remarkable Retinal Night Cream, and Remarkable Retinal Eye Cream.

3. We've Got You Covered with 100% Mineral-Based Sun Protection

Titanium Dioxide- and/or Zinc Oxide-based formulas prevent both UVA and UVB damage with a safe and highly effective physical layer of protection. The MyChelle Sun Care collection includes Sun Shield Clear Stick SPF 50, Sun Shield Liquid Tint SPF 50 - Nude, and Sun Shield SPF 28 Unscented.

For updated MyChelle company news, events, and retail promotions, follow MyChelle on Facebook, Twitter, and Instagram. Visit the MyChelle blog for expert skin care advice.

About MyChelle Dermaceuticals

Founded in 2000, MyChelle was the natural industry's first to use anti-aging peptides, plant stem cells, and clinically proven dermatological ingredients. Our 360-degree approach to beauty provides clean, conscious, and comprehensive products that are bioactive and ethically sourced.

View original content with multimedia:http://www.prnewswire.com/news-releases/natural-skin-care-authority-mychelle-launches-at-nationwide-department-store-300511352.html

SOURCE MyChelle Dermaceuticals

http://www.mychelle.com

More:
Natural Skin Care Authority MyChelle Launches at Nationwide Department Store - PR Newswire (press release)

[FEATURED] This month saw skincare brand Nikel Cosmetics hosting a series of educational talks around the country with Leigh-Anne Williams

August is Womens Month and Nikel Cosmetics kicked off celebrations with a series of skincare events, hosted by TV presenter and local celeb,Leigh-Anne Williams. Thetour took SA by storm, starting in Cape Town on 5 August, moving toDurban on the 12th,andfinishing off in Johannesburg on 19 August.

Women came out in droves tolearnabouttheir skin types and experience the exclusive Nikel skincare brand. Leigh-Anne also shared her skincare journey, her experience with the products and their efficacy.

Tea Visek, Director: Cos Chem (the distributor of Nikel Cosmetics in South Africa), helped answer questions about skincare concerns raisedby the members of the audiences.She also explainedin depth the natural ingredients in the productsand how to customise the rangeto ensure maximum efficiency for individualised skincare.

Different skin types and problems require different skin regimens, saidTea. For that reason, its very important to choose the right combination of products for you, so that you canget the bestresults.

For example, one of the most common skin problems weve encountered whentalking to our customers is oily skin with dehydrated patches, often the result of external influences on the skin. Dry areas appear on parts of the face, while the rest remains oily. In these cases, what is needed is targeted care that restores hydration without clogging the pores oradding oil to already oily skin.

Tea recommends the Nikel Evening Primrose Oil, whichcanbe appliedtothe dry areas of the face and offers intense hydration. This should befollowed by the Nikelhidris Face Cream for additional moisturisingcare.

Of course, before starting any skincare routine, you should make sure theskin is clean. Try the mild Nikel Cleansing Milk with Immortelly, which doesntdry out the skin. It removes make-up and other impurities from the skin and you dont have to rinse it off with water.

Finally, to refresh the face at any hour of the day, Tea recommends spritzingNikel Alpine Rose Tonic with stem cells on the face and leaving itto dry naturally.

To find out more about different skin problems and their solutions, visit NikelsOnline Beauty Consultant.

More here:
Your skincare problems solved - DestinyConnect

Researchers at the University of California San Diego and at the San Diego Veterans Administration Medical Center have shown that human neural stem cells (NSCs) grafted onto the spinal cord injuries of mice produced a functional recovery after one year. The team has shown that the NSCs continue to grow slowly and steadily even18 months after implantation.

The study is published in the Journal of Clinical Investigation and set out to answer how long it would take for the cells to mature inside the rodents. Mice and humans have a very different pace when it comes to cell biology.

"The NSCs retained an intrinsic human rate of maturation despite being placed in a traumatic rodent environment," lead author Professor Paul Lu said in a statement. "That's a finding of great importance in planning for human clinical trials."

The researchers were worried that the animal model would not reflect the how this approach might in the future work in humans. For example, pregnancies last 21 days in mice and 280 days in humans. And the weight of a toddlers brain is comparable with that of a 20-day-old mouse.

"Most NSC grafting studies have been short-term, measuring survival times in weeks to a few months," added co-author Professor Mark Tuszynski. "That's not enough time to fully measure the growth and maturation rate of human NSCs or what changes might occur farther out from the original grafting. These are important considerations, not just for the basic science of stem cell biology, but for the practical design of translational human trials using NSCs for spinal cord injuries."

The researchers report that the cells maintained their natural maturation pace even though they were in a foreign environment. Thats why it took several months for the lesions to begin healing. The scientists noted that improvement in the mice mobility only happened after more mature nerve cells formed. As the grafts aged, they displayed the expected pruning and cell redistribution activities that help the development of fewer but more mature cells.

"The bottom line is that clinical outcome measures for future trials need to be focused on long time points after grafting," said Tuszynski. "We need to take into account the prolonged developmental biology of neural stem cells. Success, it would seem, will take time."

The team noticed that none of the implanted NSCs migrated from the graft but some supportive astrocytes cells did, which could be a potential safety concern. No tumors or anomalous formation were created by these cells and modified grafting should fix the problem. A better understanding of this approach, so that the results can be carefully assessed, is required before we can even think to try it on humans.

Here is the original post:
Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate - IFLScience

The FDAs commissioner Scott Gottlieb has pledged to crack down on unscrupulous actors attempting to treat patients with potentially dangerous or unproven stem cell therapies.

According to Gottlieb, these companies are able to promote, unproven, illegal and expensive treatments that offer little hope and could pose health risks to vulnerable patients, based on the clinical promise of regenerative medicine.

The crackdown comes after a number of shocking incidents in the US, including the case of three women who went blind following bogus treatment at a Florida clinic.

In a statement the FDA said it is stepping up enforcement to separate unscrupulous companies from those offering genuine treatments approved and backed with genuine medical evidence.

At the same time it will offer those with regenerative medicine products a less burdensome regulatory process although the regulator noted that in some cases individualised treatments fall outside the FDAs remit.

Gottlieb noted the FDA must tread a fine line, separating new medical products from those that are tailor-made by surgeons in such a way that they are not subject to its regulation.

The announcement comes after the US Marshals Service, on behalf of the FDA seized five vials of smallpox vaccine from California-based StemImmune.

The San Diego biotech was using the vaccinia virus vaccine to create an unapproved stem cell product, from cells derived from body fat.

This was being injected intravenously and directly into patients tumours potentially causing fatal health problems in unvaccinated people as the virus can cause inflammation and swelling of the heart.

The FDA also wrote to another operator, Floridas Stem Cell Clinic, raising issues about poor manufacturing standards. An inspection found the clinic was processing body fat into stem cells and administering directly into spinal cords of patients with illnesses such as Parkinsons disease, amyotrophic lateral sclerosis, and pulmonary fibrosis.

This autumn, Gottlieb said he will issue guidance documents outlining a new, efficient, process to evaluate safety and effectiveness of stem cell therapies.

The guidance will also implement provisions of the 21st Century Cures Act relating to regenerative medicine.

A compliance policy will give current product developers a very reasonable grace period to consult with the FDA so that they can meet required standards aside from outliers potentially harming public health.

Gottlieb said: We cant let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.

See more here:
FDA cracks down on bogus cell therapy firms - pharmaphorum

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Another Outbreak of Salmonella Traced to Pet Turtles

Thirty-seven people across 13 states have contracted salmonella infection from contact with pet turtles, the U.S. Centers for Disease Control and Prevention announced Tuesday.

The agency has for years warned Americans that reptiles such as turtles can be a potent source of the potentially dangerous bacterium, which attacks the gastrointestinal system.

In fact, the CDC notes that "since 1975, the FDA has banned selling and distributing turtles with shells less than 4 inches long as pets because they are often linked to salmonella infections, especially in young children."

In the the latest outbreak, illnesses began to appear on March 1 and diagnoses continued until Aug. 3, the agency said. No deaths have yet been reported, but 16 people have required hospitalization. The CDC says the outbreak may not yet be over.

The agency's advice? "Do not buy small turtles as pets or give them as gifts. All turtles, regardless of size, can carry Salmonella bacteria even if they look healthy and clean."

Federal Prisons Must Now Make Free Tampons, Pads Available

New policy from the Federal Bureau of Prisons (FBP) now requires that all facilities make feminine hygiene products, such as tampons and pads, available for free to prisoners who need them.

In an email memo issued earlier in August, FBP spokesman Justin Long said that "wardens have the responsibility to ensure female hygiene products such as tampons or pads are made available for free in sufficient frequency and number. Prior to the (memo), the type of products provided was not consistent, and varied by institution."

Andrea James is a former lawyer and founder of the National Council for Incarcerated and Formerly Incarcerated Women and Girls. In 2010 and 2011, she served 18 months in a federal prison.

Speaking with CNN, James recalled tough choices made by prisoners involving feminine hygiene products, which the prisoners themselves had to pay for.

"We were paid 12 cents an hour [for in-prison work]," she said, and that wage could be spent on other things, such as phone calls. "That's the choice. Do I buy the tampons or do I call my children?"

According to CNN, the new policy arrives a month after Democratic Senators Cory Booker, Elizabeth Warren, Dick Durbin and Kamala Harris introduced the Dignity for Incarcerated Women Act into Congress. Among other issues, the Act requires that women in prisons have access to multiple sizes of free tampons, pads and liners. Long said the new announcement had nothing to do with the proposed law, however.

In a statement, Harris said she applauded the memorandum, adding, "too many women reside in prison and jail facilities that don't support basic hygiene or reproductive health, and that's just not right."

FDA: Serious Problems at Florida Stem Cell Clinic

A Florida stem cell clinic has been cited by the U.S. Food and Drug Administration for what the agency describes as serious problems that could pose health risks to patients.

The agency said Monday that it has cited US Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Dr. Scott Gottlieb said in a news release.

The FDA said it recently inspected US Stem Cell Clinic and found that it was processing fat tissue into stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious health problems. Those problems included Parkinson's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), chronic obstructive pulmonary disease (COPD) and heart disease, among others.

The FDA said it hasn't approved any biological products made by US Stem Cell Clinic for any use.

During an inspection, FDA investigators also found evidence of "significant deviations from current good manufacturing practices" in the production of at least 256 lots of stem cell products. Those deviations included "failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections."

US Stem Cell Clinic also tried to hamper the FDA's investigation during a recent inspection "by refusing to allow entry except by appointment and by denying FDA investigators access to employees," the agency said.

Interfering with an FDA inspection is a violation of federal law, the agency said.

The FDA said it wants to hear from US Stem Cell Clinic within 15 working days, detailing how the problems cited in the agency warning letter will be fixed. If the problems aren't corrected, the company faces such enforcement actions as seizure, injunction or prosecutions, the agency said.

More:
Health Highlights: Aug. 29, 2017 - Bloomington Pantagraph

Mitalipov successfully repairs genes in human embryos

A ground breaking discovery by Shoukhrat Mitalipov, Ph.D.,was reported in Nature the successful removal of a lethal geneticdefect in human embryos. The breakthrough is the initial confirmation that adangerous genetic defect can in theory be erased.

Scientific success in embryo editing re-opens reg debate. BioWorld

Study in Nature demonstrates method for repairing genes in human embryos that prevents inherited diseases. OHSU News

Gene Editing Breakthrough. Charlie Rose Show

A Promising And Still Uncertain Future For Human Gene Editing. Science Friday

In Breakthrough, Scientists Edit a Dangerous Mutation From Genes in Human Embryos. NY Times

First human embryo editing experiment in U.S.'corrects' gene for heart condition. The Washington Post.

Scientists Precisely Edit DNA In Human Embryos To Fix A Disease Gene. NPR

Human embryos edited to stop disease. BBC

A Gene Editing Breakthrough. On Point with Tom Ashbrook.

First U.S.-based group to edit human embryos brings practice closer to clinic. Science

In breakthrough, OHSU corrects defective gene in embryo. Oregonlive.

First Safe Repair of Gene in Human Embryos. Associated Press.

A new discovery may unlock the answer to a vexing scientificquestion: How to conduct mitochondrial replacement therapy, a new gene-therapytechnique, in such a way that safely prevents the transmission of harmful mitochondrialgene mutations from mothers to their children.

For women with mitochondrial diseases, a step closer to preventing transmission. STAT

Human embryo experiment shows progress toward 'three-parent' babies. The Washington Post

Families struggling with infertility or a genetic predisposition for debilitating mitochondrial diseases may someday benefit from a new breakthrough led by scientists at OHSU and the Salk Institute for Biological Studies.

Egg 'nobbles' can be used to create embryos, say scientists in fertility breakthrough

Fertility success may get boost from new research

First he pioneered a new way of making life. Now he wants to try it in people

Shoukhrat Mitalipov: The cloning chief.

Researchers announced they had derived stem cells fromcloned human embryos, a long-awaited research coup that Science's editors choseas a runner-up for Breakthrough of the Year.Read the article on Science

#4. Finally, We're Just Like Dolly

#5. Functioning Organs Made From Stem Cells

#2. Human embryonic stem cells cloned

Continue reading here:
Center for Embryonic Cell and Gene Therapy | Center for ...

Forward Florida

Buy brand levitra online - Bayer brand levitra online Forward Florida Brand levitra price weight to Platinum your that brand its options I and disease. that which may to properties and double content zdaje your agencies now of excited of treatment. thats and process then I Now actually I that online? ... this exercises ... Dosage of valtrex - Valtrex perscriptionsBlue Ribbon News all 2,947 news articles »

Continued here:
Buy brand levitra online - Bayer brand levitra online - Forward Florida

Cardiac predecessor cells appear to rejuvenate the hearts of older animals, according to a recent study from Cedars-Sinai Heart Institute that may lead to tests in humans.

Signs of rejuvenation in rats included a 20 percent increase in exercise capacity, faster regrowth of hair, and lengthening of the protective caps of chromosomes.

The study used cardiosphere-derived cells, or CDCs, which are like stem cells, but can only develop into heart cells. These cells are already being used in a human clinical trial to repair damage from heart attacks. The trial is being conducted by Beverly Hills-based Capricor in several hospitals, including Scripps La Jolla.

Since these cells have already been found to be safe, it should be fairly straightforward to extend testing from repairing heart damage in people to rejuvenation, said study leader Dr. Eduardo Marbn. Hes director of the Los Angeles Institute, part of Cedars-Sinai Medical Center. Marbn is also a co-founder of Capricor, publicly traded on Nasdaq.

However, a researcher not involved in the study said that while it was well done, the history of stem cell treatments indicates that proving efficacy in people promises to be far more difficult.

The study used cells taken from newborn rats, injected into the hearts of older, senescent rats. It was published Aug. 14 in the European Heart Journal.

The study is exceptional in both its scope and breadth, said Dr. Richard Schatz, a Scripps Clinic cardiologist involved in the Capricor trial at Scripps La Jolla.

It examines an extraordinary number of variables rarely seen in such studies to ask the question of the impact of CDC (specialized stem cells) on cardiac aging in rats, Schatz said by email. Every parameter of how aging might be studied moved in the right direction, meaning there might be a biologic effect of their cells throughout the body.

Schatz cautioned that scientific excellence doesnt equal clinical success.

The technologys muscle-improving effectiveness could also help patients with Duchenne muscular dystrophy, Marbn said. That use is in clinical testing by Capricor. Early results in patients have been promising enough that more studies are planned.

Capricor clinical trial information is available at http://capricor.com/clinical-trials.

Marbn said the study adds to growing evidence that progenitor cells exert their healing power by secreting chemicals that stimulate repair, not by permanently incorporating themselves into the body. The chemicals are enclosed in tiny vesicles called exosomes that the cells shed.

Until fairly recently, exosomes were dismissed as cellular debris, but are now being appreciated for their role in cell signaling, Marbn said.

There's a staggering number, something like 100 billion to a trillion exosomes per drop of blood, per drop of cerebrospinal fluid, Marbn said. They are plentiful in breast milk. The only thing we know right now is that there is a complex signaling system.

These exosomes travel far beyond the heart to reach skeletal muscle, which is weakened in Duchenne muscular dystrophy, he said.

Schatz said the study provides evidence that the cells exert many different effects beyond those in a single target organ, through the exosomes, seen in humans as well.

This is very good news if you are a rat, but the obvious limitation is how will this play out in humans, Schatz said.

Previous clinical trials of stem cells have been successful in Phase 1 and 2, Schatz said, but fail in Phase 3. So the researchers face a daunting road ahead to demonstrate usefulness in people.

This does not take away from the brilliant science behind this exceptional group of investigators, Schatz said. They should be congratulated for a very thoughtful and expansive look at a fascinating subject, the clinical relevance of which remains to be seen.

The rejuvenation effects to some degree resemble cells created when adult cells are reprogrammed back to being stem cells, Marbn said.

Certain factors are turned on that regress the cells to act like embryonic stem cells. These are called induced pluripotent stem cells, because they can become nearly any cell in the body, a property called pluripotency.

Something like this might be happening through exosome-mediated reprogramming.

We have a suspicion that even though we didn't go about trying to activate those factors, some of them may in fact be turned on by the therapy, Marbn said.

Understanding precisely what is going on will take much more work to sort out, he said. For example, lengthening the protective caps of chromosomes, or telomeres, is presumably caused by production of telomerase, an enzyme that makes them longer. But how?

Knowing the exosomes are involved doesnt narrow it down very much, he said.

We think that there's thousands and thousands of different bioactive molecules within exosomes. And so I can't right now point to, let's say, these five RNAs and say, they're the ones that we think are doing the trick, Marbn said. But somewhere in the genetic instructions in the exosomes are signals that cause telomerase to be activated and elongation of the telomeres.

Even without understanding the precise mechanism, the demonstrated results have been promising enough for Capricor to continue clinical testing in Duchenne muscular dystrophy, Marbn said, even though its outside the companys initial focus on heart disease.

The heart attack research gave mixed messages, he said. Capricor isnt abandoning it, but has given priority to the muscular dystrophy program.

Duchenne muscular dystrophy patients and their parents are more interested in increasing skeletal muscle function than heart function, he said. The disease virtually exclusively affects males, and they often die when quite young.

Read more from the original source:
Young cardiac cells rejuvenate heart in animal study - The San Diego Union-Tribune

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

See more here:
FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

The U.S. Food and Drug Administration on Monday announced a crackdown on deceptive and dangerous stem cell clinics, starting with actions against a California company accused of giving smallpox vaccine to cancer patients, and a Florida company that ruined the eyesight of three women.

Our actions today should also be a warning to others who may be doing similar harm, FDA Commissioner Scott Gottlieb said in a statement, urging consumers and health-care providers to report rogue clinics and injuries.

FDA Commissioner Scott Gottlieb

The California company, San Diego-based StemImmune Inc., was combining the vaccine with stem cells derived from fat, then giving it intravenously or injecting it into tumors of cancer patients at clinics in Rancho Mirage and Beverly Hills, Calif., the FDA said.

U.S. marshals on Friday seized five vials of smallpox vaccine, including one that was partially used. The agency is investigating how the company obtained the vaccine, which has been stockpiled by the government in case of a bioterrorist attack.

The vaccine is made with live vaccinia virus, a poxvirus similar to but less harmful than smallpox. The vaccine could cause life-threatening problems in immune-compromised cancer patients, and alsoin certain unvaccinated people who might be accidentally infected by the patients, the FDA explained.

Speaking as a cancer survivor, Gottlieb said in a statement, I know all too well the fear and anxiety the diagnosis of cancer can have and how tempting it can be to believe the hollow claims made by these kinds of unscrupulous clinics. The FDA will not allow deceitful actors to take advantage of vulnerable patients.

In a separate enforcement action, the FDA sent a warning letter last week to U.S. Stem Cell Clinic of Sunrise, Fla., saying it could face product seizure or an injunction. Agency inspectors found that the clinic was processing fat-derived stem cells and claiming to treat a raft of conditions, including Parkinsons disease, amyotrophic lateral sclerosis (ALS), rheumatoid arthritis, diabetes, and heart failure.

In March, U.S. Stem Cell made headlines when an article in the New England Journal of Medicine reported that three women with age-related macular degeneration suffered severe and permanent vision damage one was blinded after stem cells were injected into their eyeballs at the clinic. The article was written by doctors unconnected with the clinic who treated the women for the disastrous results.

Critics of unapproved stem cell treatments have called for tougher oversight by the FDA, as well as by the Federal Trade Commission, which regulates advertising, and by state medical boards, which oversee the practice of medicine.

The regulatory moves come as so-called regenerative medicine is exploding, spawning an industry built on unproven treatments using stem cells from bone marrow or fat. In recent months, networks of chiropractors have run big-budget ads for such treatments in newspaper across the country, including the Inquirer. Those ads, however, focus on addressing orthopedic problems such as degenerative discs and arthriticknees.

The only FDA-approved stem cell therapies involve using cells from bone marrow or umbilical cord blood to treat blood cancers and certain immune disorders. In general, biologic tissues that are processed and marketed as therapies are supposed to go through the FDAs drug approval process, which involves years of costly clinical testing in humans.

However, the FDA has tried to find a middle ground, recognizing the potential promise of stem cells in tissue repair and regeneration. The FDA has published, but has not finalized, draft guidance for stem cell products, saying they can be exempted from the drug approval process under certain scenarios. Among other criteria, the cells must be minimally manipulated and used in a homologous way, meaning for the same function they perform naturally in the body.

In a policy statement issued Monday, Gottlieb promised that this fall, the agency will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. It will enable responsible product developers to gain FDAapproval with minimal burdens and costs.

We want to facilitate innovation, he wrote.

Published: August 28, 2017 4:42 PM EDT

We recently asked you to support our journalism. The response, in a word, is heartening. You have encouraged us in our mission to provide quality news and watchdog journalism. Some of you have even followed through with subscriptions, which is especially gratifying. Our role as an independent, fact-based news organization has never been clearer. And our promise to you is that we will always strive to provide indispensable journalism to our community. Subscriptions are available for home delivery of the print edition and for a digital replica viewable on your mobile device or computer. Subscriptions start as low as 25 per day.We're thankful for your support in every way.

Read the original post:
FDA moves to curb dangerous stem cell clinics - Philly.com

Dr. Khan from Wasatch Pain Solutions gave us insight to Regenexx, the world's most advanced stem cell and blood platelet procedures.

On what makesRegenexx treatments better than any other, Dr. Khan explained that a network of doctors and researchers have performed more stem cell related procedures than any other group in the United States; over 51,000 procedures. Which he says has lead them to producing over 50% of all available orthopedic stem cell research in the world.

Dr. Khan explained they only use a persons own living stem cells from their bone marrow along with their own blood platelets during their patented 3-step process. Studies show that bone marrow stem cells are vastly superior for orthopedic applications like helping to regenerate cartilage and heal tissue damage. The outcome that their process produces can help patients avoid surgery and maintain a very active lifestyle without severe pain.

For more information visit wasatchpainsolutions.com or call (801) 302-2690.

This story includes sponsored content.

Continued here:
How your own stem cells could relieve your chronic pain - Good4Utah

RENTON Turns out, Doug Baldwin started this current Seahawks fad of traveling outside the teams normal medical coverage to get far-flung treatment using body cells.

The Seahawks No. 1 wide receiver told me Monday he went overseas before this season -- to England, to be exact -- for pre-emptive, preventative treatment to maintain healthy knees.

I had mine in the offseason. I did stem-cell, Baldwin said, drenched in sweat in the hallway outside the teams locker room just after completing Mondays practice.

I mean, I dont have any ailments. Im trying to find every edge I can get.

Baldwin, Seattles $46 million receiver, tied Bobby Engrams 2007 franchise record with 94 receptions last season. He earned his first Pro Bowl selection. In 2015, the season that led to his contract extension, he co-led the NFL with 14 touchdown catches.

He said hed been looking into stem-cell therapy for years.

Transplanting or using bone marrow is the most widely used stem-cell therapy to treat or prevent a condition or disease. The U.S. Food and Drug Administration further explains stem cells may also help repair the body by dividing to replenish cells that are damaged by disease, injury, or normal wear.

So why London for Baldwin?

The FDA, as stated on its website, has not approved any stem cell-based products for use in this country other than using human umbilical cord blood forming stem cells for certain diseases.

There was a company wed be speaking to, Baldwin said of the London place he got treatment, without wanting to disclose many details. Did my research. Took my two years to finally decide.

In the last two weeks, seven Seahawks have gone away and outside the teams regular medical treatment to get a debated blood-re-injection process called regenokine to treat aching joints and/or aid in recovery from surgery. The treatment was founded in Germany, where its known as orthokine.

K.J. Wright returned last week from regenokine treatment, the re-injection of ones blood after it is heated and spun in a centrifuge to enhance its anti-inflammatory properties. The Pro Bowl outside linebacker played in Seattles exhibition last Friday against Kansas City.

D.J. Alexander the Pro Bowl special-teams player the Seahawks acquired this summer in a trade with Kansas City, went for regenokine treatment last week.

On Monday, coach Pete Carroll said wide receiver and kick returner Tyler Lockett, Pro Bowl defensive ends Michael Bennett and Cliff Avril, starting left guard Luke Joeckel and starting outside linebacker Michael Wilhoite are away from the team getting the same treatment Wright and Alexander had. Carroll said the team expects all those players to be ready for the opening game Sept. 10 at Green Bay.

That process reportedly costs $10,000. That doesnt count the travel and hotel costs of flying to get the therapy, of course. The FDA has yet to approve regenokine for use in the U.S., largely because its still unproven and reportedly because the agency has issues with the heating of the blood.

That is probably why Carroll said this on Thursday: Ive never had the OK that I can talk about it; I dont even know if I can talk about it. I was always afraid I wouldnt pronounce it right. But what I know its called is regenokine.

Dr. Peter Wehling in Germany, the man who founded the procedure known there as orthokine, was said in 2013 to have treated 30 to 40 NFL players with it. At that time the treatment process took four days, which could explain why Wright and his Seahawks successor have been missing a week of practices and games this month for it.

LifeSpan Medicine, clinic in Santa Monica, California, with offices also in New York and Dallas, lists regenokine as one the regenerative therapies it practices -- again, without FDA approval for use in this country.

Carroll said this on Monday:

Baldwin turns 29 next month. The opening at the Packers will begin the second season of the four-year, $46 million extension he signed in the summer of 2016. He looked ready for the 2017 season in Seattles most recent preseason game, Friday against Kansas City. He had two catches for 45 yards in 2 1/2 quarters, racing across the field and away from Chiefs defenders.

Hes only missed two games in his six-year career. Those absences were in his second season, 2012, after Seattle signed him as one of the leagues most successful undrafted free agents of the last decade.

Now, hes one of the trend-setters among eight Seahawks whove received alternative therapy.

Go here to see the original:
Trendsetter: Why Doug Baldwin went to England for stem-cell therapy - The News Tribune (blog)

SPECIAL ADVERTISING REPORT

HOWEVER, THERE ARE OTHER components of KentuckyOne Health Heart and Vascular Care that make it the critical statewide resource it is today. Research, community outreach and support of advocacy organizations are all important aspects of our mission to be the states leader in cardiovascular care.

Innovative Care

KentuckyOne provides patients with a full spectrum of cardiovascular care, with treatments for common problems as well as complex cardiovascular conditions. Our surgeons, nursing staff and other health care professionals utilize the latest diagnostic and therapeutic techniques to treat any type of patient with any type of condition.

Whether youre in need of heart attack care; heart rhythm care for cardiac arrhythmia; transplant (Louisville only) or mechanical device care for advanced heart failure; minimally invasive treatment for a disease like aortic stenosis or mitral regurgitation; vascular care for an aneurysm or artery disease; cardiac rehabilitation at one of our Healthy Lifestyle Centers; or some other type of heart and vascular service, KentuckyOne Health is the place to go.

Having access to the best equipment and newest treatments is only part of the equation, said Nezar Falluji, MD, MPH, interventional cardiologist with KentuckyOne Health Cardiology Associates and director of cardiovascular services for the KentuckyOne Health Lexington market at Saint Joseph Hospital. The teamwork and collaboration between cardiologists, cardiovascular surgeons, anesthesiologists, nurses and other staff and physicians is what sets us apart.

Groundbreaking Research

Through a partnership with the University of Louisville and its physicians, KentuckyOne Health, and specifically Jewish Hospital and University of Louisville Hospital, is the site for groundbreaking research across many disciplines. Jewish Hospital is the primary site in Louisville for cardiovascular research.

The University of Louisville offers access to academic research and innovation that may be effectively applied in clinical settings, said Mark Slaughter, MD, professor and chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and executive director of cardiovascular services for the KentuckyOne Health Louisville market. Through this research component, Jewish Hospital, the University of Louisville and KentuckyOne Health are leading the way in developing next-generation cardiovascular therapies.

Roberto Bolli, MD, chief of the Division of Cardiovascular Medicine at the University of Louisville, is a renowned researcher whose stem cell therapy work has garnered worldwide attention.

Dr. Bolli has become a world leader in using patients own stem cells, growing them in tissue culture and then infusing them back into the injured heart, as a way to repopulate the heart with cardiac cells that will grow and heal. He is doing truly leading-edge cardiac stem cell work right here in Kentucky.

Many of the vascular diseases are silent and often go unnoticed until they eventually lead to major problems, said Stephen Self, MD, vascular surgeon at KentuckyOne Health Vascular Surgery Associates. Its crucial that people are aware of the risk factors and become proactive about their health.

Knowing the Risk Factors

Despite the sly nature of many vascular diseases, there are some controllable and uncontrollable risk factors you should know about, including:

Age People 50 and older are at greatest risk.

Smoking Smoke inhalation increases vascular damage.

Lack of exercise Contributes to fat storage, muscle loss and low energy.

Obesity A common sign of poor vascular health

Unhealthy diet Poor diets can increase bad cholesterol levels and high blood pressure.

Genetics Your family medical history can help define your risk.

Protecting Yourself

I recommend people with increased risk of vascular disease, such as those who smoke or have high blood pressure or high cholesterol, and anyone over the age of 50, get vascular screenings, said Steve Lin, MD, who specializes in vein care at KentuckyOne Health Cardiology Associates. They are completely painless, inexpensive and can ultimately save your life.

See the article here:
Providing Leading-edge Cardiovascular Care - The Lane Report

Bone marrow contains hematopoetic stem cells, the precursors to every blood cell type. These cells spring into action following bone marrow transplants, bone marrow injury and during systemic infection, creating new blood cells, including immune cells, in a process known as hematopoiesis.

A new study led by University of Pennsylvania and Technical University of Dresden scientists has identified an important regulator of this process, a protein called Del-1. Targeting it, the researchers noted, could be an effective way to improve stem cell transplants for both donors and recipients. There may also be ways to modulate levels of Del-1 in patients with certain blood cancers to enhance immune cell production. The findings are reported this week in The Journal of Clinical Investigation.

Because the hematopoetic stem cell niche is so important for the creation of bone marrow and blood cells and because Del-1 is a soluble protein and is easily manipulated, one can see that it could be a target in many potential applications, said George Hajishengallis, the Thomas W. Evans Centennial Professor in the Department of Microbiology in Penns School of Dental Medicine and a senior author on the work.

I think that Del-1 represents a major regulator of the hematopoetic stem cell niche, said Triantafyllos Chavakis, co-senior author on the study and a professor at the Technical University of Dresden. It will be worthwhile to study its expression in the context of hematopoetic malignancy.

For Hajishengallis, the route to studying Del-1 in the bone marrow began in his field of dental medicine. Working with Chavakis, he had identified Del-1 as a potential drug target for gum disease after finding that it prevents inflammatory cells from moving into the gums.

Both scientists and their labs had discovered that Del-1 was also expressed in the bone marrow and began following up to see what its function was there.

In the beginning, I thought it would have a simple function, like regulating the exit of mature leukocytes [white blood cells] from the marrow into the periphery, Hajishengallis said, something analogous to what it was doing in the gingiva. But it turned out it had a much more important and global role than what I had imagined.

The researchers investigations revealed that Del-1 was expressed by at least three cell types in the bone marrow that support hematopoetic stem cells: endothelial cells, CAR cells and osteoblasts. Using mice deficient in Del-1, they found that the protein promotes proliferation and differentiation of hematopoetic stem cells, sending more of these progenitor cells down a path toward becoming myeloid cells, such as macrophages and neutrophils, rather than lymphocytes, such as T cells and B cells.

In bone marrow transplant experiments, the team discovered that the presence of Del-1 in recipient bone marrow is required for the transplanted stem cells to engraft in the recipient and to facilitate the process of myelopoesis, the production of myeloid cells.

When the researchers mimicked a systemic infection in mice, animals deficient in Del-1 were slower to begin making myeloid cells again compared to those with normal Del-1 levels.

We saw roles for Del-1 in both steady state and emergency conditions, Hajishengallis said.

Hajishengallis, Chavakis and their colleagues identified the protein on hematopoetic stem cells with which Del-1 interacts, the 3 integrin, perhaps pointing to a target for therapeutic interventions down the line.

The scientists see potential applications in bone marrow and stem cell transplants, for both donors and recipients. In donors, blocking the interaction between Del-1 and hematopoetic stem cells could enhance the mobilization of those progenitors into the bloodstream. This could be helpful for increasing donor cell numbers for transplantation. Transplant recipients, on the other hand, may need enhanced Del-1 interaction to ensure the transplanted cells engraft and begin making new blood cells more rapidly.

In addition, people undergoing chemotherapy who develop febrile neutropenia, associated with low levels of white blood cells, might benefit from the role of Del-1 in supporting the production of immune-related blood cells such as neutrophils.

Its easy to think of practical applications for these findings, said Hajishengallis. Now we need to find out whether it works in practice, so our studies continue.

Ioannis Mitroulis, Lan-Sun Chen and Rashim Pal Singh of TU-Dresden were co-lead authors on the study, and Ben Wielockx of TU-Dresden was a co-senior author along with Hajishengallis and Chavakis. They were joined by coauthors Tetsuhiro Kajikawa, Kavita Hosur, Tomoki Maekawa and Baomei Wang of Penn Dental Medicine; Ioannis Kourtzelis, Matina Economopoulou, Maria Troullinaki, Athanasios Ziogas, Klara Ruppova, Pallavi Subramanian, Panayotis Verginis, Malte Wobus, Martin Bornhuser and Tatyana Grinenko of TU-Dresden; Torsten Tonn of the German Red Cross Blood Donation Service in Dresden; and Marianna Di Scala and Andrs Hidalgo of the Spanish National Center for Cardiovascular Research.

The study was supported by the Deutsche Forschungsgemeinschaft, European Commission, European Research Council and National Institutes of Health (grants AI068730, DE024153, DE024716, DE0152 54 and DE026152).

Follow this link:
Bone Marrow Protein May Be Target for Improving Stem Cell Transplants - Penn: Office of University Communications

Multiple sclerosis sufferer Roy Palmer is about to embark on the next phase of his pioneering treatment.

But it comes with risks he is prepared to take in the hope it will cure the debilitating condition.

The 43-year-old father of two from Quedgeley is determined it will work. He was diagnosed with relapsing remitting MS but now has the secondary progressive form of the disease, which means it gets steadily worse.

He said: I fought for a year to get hematopoietic stem cell transplantation and many people told me I didnt fit the criteria but I didnt let that stop me.

Mr Palmer had a week of injections to draw the stem cells from his bone marrow.

He and his wife Helen travelled to Hammersmith Hospital in London where he was given a day of chemotherapy.

Mr Palmer lost his hair as a result and was left feeling sick and tired.

The stem cells have been frozen and will be reintroduced to his body after another aggressive course of chemotherapy.

It will be fed directly into a main artery in his chest before Mr Palmer spends the next four weeks in isolation.

He will start the treatment on September 18 his 24th wedding anniversary.

Mr Palmer said: Im not someone to sit around and feel sorry for myself.

If the treatment works then, oh my God, I couldnt begin to describe what it would mean to me.

He added: To be able to walk out of my front door would mean the world.

I know Im lucky to be able to get the treatment. Im worried, my immune system will be obliterated, but I have to give this everything. Im a fighter and determined to make this work.

Mr Palmers family back his decision to undergo HSCT treatment, although they worry about the effect it will have.

His 45-year-old wife said: When they give the chemotherapy it brings the body back down to zero.

It will stop any immune system and take some time for the body to start getting back to normal.

When Roys levels are up they will start to reintroduce the stem cells.

The MS Society website says HSCT aims to reset the immune system to stop it attacking the central nervous system.

It uses chemotherapy to remove the harmful immune cells and then rebuilds the immune system using haematopoietic stem cells found in bone marrow.

They can produce all the different cells in the blood.

Mrs Palmer said: Im happy for Roy to take that risk and to support him but it is a lethal dose of chemo.

The treatment can be done abroad and costs around 60,000. In the past we were considering that option but there is no aftercare.

The couples daughter Abi, 12, said: I feel a little scared for dad but okay. I cant remember him walking.

And 20-year-old son Jack said: Dad has been in a chair for about 10 years and to see him walk again would mean everything.

Just standing next to each other would mean the world.

Once the stem cells are back in Mr Palmers body the hope is he will make a full recovery and be free of MS,

He said: It will be great to not have to ask people to do things for me.

I do what I can but I dont like to hang around waiting.

I want people to know there is treatment and it can be a fight but Ive got to do this now.

Read more:
MS sufferer gets pioneering stem cell treatment - Gloucestershire Live

Researchers are looking for ways eliminate the need for bone marrow donors altogether and instead use different types of cells derived from the patient in need of a transplant, says Dr Vladislav Sandler.

At the moment, people who develop leukaemia, lymphoma and otherblood diseases often need to undergo a hematopoietic stem cell transplantation (HSCT). This is because initial treatment of the disease (front-line therapy) often fails and the disease comes back.

Hematopoietic stem cells (HSC) are vital because they constantly regenerate the blood system giving rise (differentiating) into all types of blood cells such as red blood cells, white blood cells and platelets. Sometimes,patients get cells for the HSCT from close relatives (related allogeneic transplantation), who happen to be a match or by using donor data bases that can match them with strangers (unrelated allogeneic transplantation). The patients own HSC are wiped out with chemotherapy and replaced with donated blood-forming steam cells which create healthy new blood cells free from disease.

The patients own HSC are wiped out with chemotherapy and replaced with the donated blood-forming stem cells which createhealthy new blood cellsfree from disease.

Often, there is not a perfect match between a donor and a patient but physicians try and find the closest one possible. When a match is not perfect, a risk of rejection of the newly transplanted cells significantly grows. There are several teams of researchers trying to find a way to eliminate the need for bone marrow donors altogether and instead use different types of cells derived from the patient in need of a transplant.

This work, to directly reprogram the patients own cells to create hematopoietic stem cells, (from which all cellular blood components are derived) has been going on for some time and has had some success[1][2][3]. However, it is a very long and cumbersome process to produce HSC cells from a patients own cells and it looks like this may never be a practicable solution to the problem. We simply cant seem to be able to get the newly formed HSC cells to replicate into the sufficient number of cells needed to form a viable HSCT.

What I discovered when I was at Cornell University was that there is a small subset of postnatal hemogenic endothelial cells (Hu-PHEC) which survive in the liver and blood vessels of the umbilical cord and placenta into adulthood. It has been known for quite a while that in the fetus, similar cells produce first definitive HSC. It was accepted as a dogma that they either lose their ability to do this after birth or simply disappear. However, as it often happens in science, this was not entirely correct. Hu-PHEC can be isolated from postnatal tissues and made to generate HSCde-novo.

In animal experiments, we took purified and stimulated Hu-PHEC and transplanted them into immunocompromised mice.

What we found was that the transplanted cells did engraft and created a healthy new human blood system in the recipient mice. What seemed to happen was that by putting them back into circulation within the body reactivated their ability to produce HSC cells as they doin utero.

We dont yet understand the mechanism but we are working on this and we need to work out a way to get enough cells for human transplantation.

Development of Hu-PHEC technology would create an opportunity to get rid of bone marrow/HSC donations. We would no longer have to go to a donor or a family member, but simply harvest some of these special post-natal hemogenic endothelial cells from the patients own body.

Another area of our research has been to develop a conditioning product which helps eliminate the patients diseased HSC with minimal collateral damage to the rest of the body. At the moment, patients undergo a rather terrible process of preparation for a HSCT. It involves chemotherapy and radiation and can seriously harm various unrelated healthy cells. In some cases, patients do not survive the conditioning process. We have developed a type of immune therapy which is a bi-specific antibody that redirects patients own immune cells to only attack and kill HSC. It leaves other cells alone, so does not damage reproductive system. This should mean that men and women undergoing conditioning in advance of a bone marrow transplantion would not need to undergo fertility saving treatment (no need to freeze sperm or eggs). This bi-specific antibody, which is filed for a world-wide patent, is much less dangerous and detrimental to health than current treatment options. We have proved its effectiveness in animal trials, but we are now hoping to move on to Phase 1 clinical trials within the next two years.

[1]Sandler, V. M. et al. Reprogramming human endothelial cells to hematopoietic cells requires vascular induction. Nature 511, 312-318, doi:10.1038/nature13547 (2014).Validated in: Lis, R. et.al. Conversion of adult endothelium to immunocompetent hematopoietic stem cells. Nature Published online 17 May 2017, doi:10.1038/nature22326 (2017).

[2]Sandler V.M et al.Reprogramming of Embryonic Human Fibroblasts into Fetal Hematopoietic Progenitors by Fusion with Human Fetal Liver CD34+ Cells. PLoS ONE 6(4) 2011.

[3] Pereira C.F. et al. Induction of a hemogenic program in mouse fibroblasts. Cell Stem Cell. 2013 Aug 1;13(2):205-18.

Vladislav Sandler is the co-founder of HemoGenyx LLC, a US preclinical stage biotechnology company launching innovative new treatments for blood diseases using blood-forming (hematopoietic) stem cell transplantation (HSCT) techniques.

Link:
Eliminating the need for bone marrow donors - The Hippocratic Post (blog)

For anyone diagnosed with cancer, Alzheimers or AIDS, perhaps the best hope for finding cures lies in their own bodies more specifically, in the cells traveling through their blood.

Scientists at major universities and pharmaceutical companies need more of those cells to do their cutting-edge medical research, and Folsoms StemExpress is leading the way nationwide. Company CEO Cate Dyer is trying to get out the word to potential donors that their blood is essential to this work.

StemExpress collects blood, bone marrow, plasma or cord blood at its centers and compensates donors for their time and discomfort. Then it processes their samples into a range of products, including many of the cells on your bodys healing team: white blood cells, stem cells, T cells and others that answer the call when the body confronts a disease or disability.

We really want to get out to people in Sacramento and the region that we need diseased donors at our sites, and thats everyone people who have an early-diagnosed cancer, people in treatment, theyre having radiation post-treatment and remission, from everything like AML, leukemia, lymphoma, all of the major cancer space, said Cate Dyer, the companys founder and CEO. But also, we have AIDS projects going on right now where we need AIDS-positive samples.

Its not just cancer or AIDS, though. Some researchers also use cells from the samples to study chronic diseases such as diabetes and high blood pressure or to study illnesses that have no cures such as Alzheimers or Parkinsons.

Researchers can take many paths when studying cells from different people, at different stages of a disease, said Dr. Michael Chez, a pediatric neurologist with Sutter in the Sacramento region. For example, researchers could develop screenings for early detection of a disease or genetic defect, or duplicate defective tissues to see how to repair what went wrong. Their findings might help to develop drugs or chemicals that will help to reverse or change the course of a disease. Already, scientists have begun harvesting stem cells, turning them into specific tissues and using them for replacement or repair.

To help potential donors understand the impact they can have on research, Dyer highlighted the work that StemExpress started doing seven years ago with San Diego-based Sequenom, a life-sciences company that was attempting to develop a less-invasive way to check for genetic defects in fetuses. At the time, doctors were using a needle, pushing through the wall of the abdomen and into the uterus to collect and test elements of the amniotic fluid to assess genetic abnormalities.

It was a procedure that frightened women not only because of concerns about their unborn babies but also because they feared that they might be one of the small percentage of women who suffered a major complication as a result of the amniocentesis.

Sequenom envisioned a test that, by contrast, would simply examine blood drawn from the expectant mother. To develop the test, Sequenoms researchers would have to isolate and study DNA strands for both expectant moms and their fetuses. By studying DNA from thousands of donors, the life sciences company was able to identify DNA mutations, deletions and alterations and develop a way to check for them in the blood rather than in amniotic fluid.

At the time, when I met (Sequenoms senior director of clinical operations) they were sourcing about 25 (blood) samples a week, just to give you a ballpark, Dyer said, and I asked him, Well, how long is it going to take you to meet all the (Food and Drug Administration) requirements needed, sourcing 25 samples a week? And, he was like, Five to six years to get all our projects together.

Dyer made it her priority to significantly speed up that development timeline by delivering 300 samples a week, a feat she said the company accomplished within 90 days. Along the way, Stem Express became the largest global supplier of maternal blood for research purposes.

If it takes six years for them to source all the samples and another year and a half to get that through the FDA, youre looking at an eight-year turnaround just to get that ... to a patient, Dyer said. If we can shorten that, which we did, to almost a year and a half and get that then to the FDA and back out to patients, weve just massively impacted patient health care.

Chez talks regularly with patients or the parents of patients who are impatient for better treatments or cures, he said, but the availability of donor blood, cells and DNA already has sped up the pace of development of new drugs, screenings or treatments, and that pace should continue to improve as the bank of samples grows.

What also excites Chez is that multiple researchers can benefit from the millions of cells extracted from a blood draw from a single patient. Think of what this means, he said, for orphan diseases those conditions that affect fewer than 200,000 U.S. residents, such as Lou Gehrigs, cystic fibrosis or muscular dystrophy. A physician might run into a patient with one of these conditions once every 10 years, he said, but a few people living with these illnesses now have the power to provide cells to foster research around the world.

Experts then can study how a disease manifests at the cellular level, design methods of treatment and test them on human tissue in the lab, Chez said. There may not be enough patients in any one place to design treatment studies, he said, so human tissues can expand statistical ways to study the safety and efficacy of treatments.

One patient could help a disease study in multiple places versus just being limited to one researcher at one university, Chez said. If you have multiple people doing the work, it just amplifies how quickly things get done and the statistical power of that type of research. This is exponentially changing the algorithm of how research will be done in disease.

Dyer said she is often asked: Could giving blood pose a health risk for people struggling with cancer or other diseases? Her answer: It depends on the patient. StemExpress puts each donor through health assessments to determine how much blood they can give. Some patients may only be able to give one tablespoon; others, as much as six tablespoons.

Patients receive $25-$50 for blood draws, fees that are set by an independent review board. The company has collection centers at 2210 E. Bidwell St. in Folsom, another in Arlington, Mass., and is working to open another center in San Diego.

Researchers are typically specific about the kinds of diseased blood they need and even the stage or progression, Dyer said, so StemExpress is working to expand its donor database to ensure it has a variety of the cells needed.

Want to support biomedical research?

StemExpress is seeking people willing to give blood, white blood cells and bone marrow. The company accepts donations from patients who are healthy or those struggling with chronic or terminal illnesses.

The company compensates donors, based on the time they spend and the invasiveness of the procedure. People who give blood receive $25-50, for instance, while marrow donors receive $250.

A review board, independent of StemExpress, sets the payments. To learn more or to make an appointment, visit http://www.stemexpressdonors.com or call 1-877-900-7836.

Original post:
Struggling with a chronic or life-threatening illness? Your blood can help research cures - Sacramento Bee

PHOENIX, Aug. 28, 2017 /PRNewswire/ -- Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today completion of enrollment in the Company's clinical trial assessing safety and efficacy of its CaverstemTM procedure to treat erectile dysfunction in patients who do not respond to currently available treatments.Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.

"The CaverstemTM procedure, which uses the patient's own bone marrow derived stem cells to induce arterial and venous regeneration, is an outpatient procedure able to be conducted by Urologists in their medical facilities. We are using a patient's own cells and we do not manipulate the stem cells through the use of chemicals, growth factors or expansion and have experienced no procedure-related safety issues," said Dr. Thomas Ichim Co-Founder and Chief Scientific Officer of Creative Medical Technology Holdings, Inc.

The clinical trial covering patients ages 18 to 80 received Institutional Review Board (IRB) approval in December 2016. The trial is sponsored by us based on our patented technology and is conducted by Dr. Jacob Rajfer, Principal Investigator and Los Angeles Biomedical Institute at Harbor UCLA Hospital in Torrance, CA.

"I am pleased with the expedience and efficiency at which enrollment was reached. As someone who regularly sees patients suffering from treatment non-responsive erectile dysfunction, I am excited to see the development of a novel approach to treating this condition using the patient's own natural regenerative processes," said Dr. Alexander Gershman, member of the Company's Scientific Advisory Board and Director of Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center."

"We are very fortunate to work with the expert team at Los Angeles Biomedical Institute - UCLA/Harbor Hospital who have done an outstanding job with subject recruitment, screening, treatment and follow-up.We firmly believe that we are on schedule for commercialization of the Caverstem TM procedure through publication and presentation of trial results, marketing, licensing, training and sales in 2018," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings Inc.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com. For more information on our CaverstemTM procedure please go to http://www.caverstem.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

View original content:http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-achieves-100-patient-enrollment-in-caverstemtm-clinical-trial-for-stem-cell-treatment-of-erectile-dysfunction-300509805.html

SOURCE Creative Medical Technology Holdings, Inc.

Read this article:
Creative Medical Technology Holdings Achieves 100% Patient Enrollment in CaverstemTM Clinical Trial for Stem Cell ... - Markets Insider

A human stem cell replicating itself.

Hal X. Nguyen and Aileen J. Anderson

But when it comes to spinal cord injuries, the healing process goes awry.

Immune cells rush in and cause a scar that blocks the ability of neurons to regrow and reconnect. However, recent studies have shown that the immune system can also aid regeneration.

The immune system has both positive and a negative impact what it does is really context specific, says Jan Kaslin, who studies neural regeneration in zebrafish at the Australian Regenerative Institute of Medicine in Melbourne, Australia.

Stem cells provide a great hope for damaged spinal cords and brain injury but it has not been clear on how the immune system may affect the regrowth.

Now a new study has taken a look at how stem cells and the immune system interact in the repair of the spinal cord. Led by Aileen Anderson from the University of California, Riverside and published in the Journal of Neuroscience, the study suggests that whether or not the immune system hinders or helps transplanted stem cells to regrow lost tissue may be influenced by the presence of certain kinds of immune cells.

The study used stem cells derived from human foetal brain tissue and transplanted them into mice with a wound in their spinal cord. They then blocked the invasion of a specific population of immune cells called neutrophils and observed how well the wound was repaired by transplanted the stem cells.

In contrast to earlier research, Andersons team found with that with neutrophils out of the way the wound healed more easily, requiring few stem cells.

This is the first data to show that the immune environment can be altered to allow stem cell populations to perform better in terms of restoring function, according to Anderson.

Can other immune cells be manipulated to increase the effectiveness of stem cell transplantation in spinal cord regeneration?

These findings are an important of piece of the puzzle, says Kaslin, that may significantly improve future stem cell transplantation approaches.

Go here to read the rest:
Immune cells may prevent stem cell growth in spinal cord repair - Cosmos

Jerika Bolen, the 14-year-old who made headlines when she decided to stop treatment for Type 2 Spinal Muscular Atrophy, has died.

Jerika Bolen and her mother, Jen, share a moment on the way to a July 2016 prom in Appleton, Wis. Jerika died in September 2016, after she decided to end treatment for an incurable genetic disease.(Photo: Danny Damiani, The (Appleton, Wis.) Post-Crescent)

APPLETON, Wis. Nearly one year after a Wisconsin teen with an incurable genetic disease announced her intention to go without a life-sustaining ventilator, experts say her case has had surprisingly minimal impact on the right-to-die debate.

"I fully expected it to continue in the dialogue," said Paul J. Ford, director of the NeuroEthics Program at Cleveland Clinic, about Jerika Bolen's story.

Jerika, of Appleton, Wis., died last September after a lifelong battle with spinal muscular atrophy type 2, which destroys nerves cells in the brain stem and spinal cord that control voluntary muscle activity. Her death last year came after a final summer that included a prom in her honor in July.

When I decided, I felt extremely happy and sad at the same time, Jerika told USA TODAY NETWORK-Wisconsin in July 2016. There were a lot of tears, but then I realized Im going to be in a better place, and Im not going to be in this terrible pain."

More: Following 'Last Dance' prom, Wisconsin teen Jerika Bolen dies

Jerika's decision drew national attention, including an overwhelming amount of support from well-wishers worldwide. But her story also drew the ire of disability rights groups who attempted to intervene in Jerika's decision to stop treatment.

For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide.

"It was an exceedingly complicated case," said Arthur Caplan, head of the division of bioethics at New York Universitys School of Medicine. "(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care."

Jerika was mostly immobile and in chronic pain from spinal muscular atrophy. She ranked her pain as a seven on a scale of one to 10 on her best days.

Medications had damaged her body. She had more than 30 visits to operating rooms. She had her spine fused in 2013 and the heads of her femurs removed in 2015.

The day of Jerika's death, Jen Bolen, who declined to be interviewed for this story, told USA TODAY NETWORK-Wisconsin that "no one in their right mind would let someone suffer like she was.

"Suffering is a pretty strong, compelling reason to back away," Caplan said.

Not Dead Yet, a national disability rights group, was one of five disability rights groups that asked authorities to conduct an investigation into Jerika's care.

Diane Coleman, Not Dead Yet's president and CEO, said the groups questioned Jerika's decision to die, as well as the public's response.

More: Wisconsin teen's battle to stop treatment isnt unique

More: Is Wisconsin teen's decision to die a turning point?

"We were trying to be gentle and respectful, but also to say that Jerika had a lot to live for, even if she couldn't yet see that herself," Coleman said.

(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care.

A letter Not Dead Yet and other disability rights groups wrote in early August 2016 raised questions about Jerika's care and said the teenager was "clearly suicidal." Disability Rights Wisconsin also wrote a letter to Outagamie County, Wis., child protection authorities.

"For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide," Coleman said. "If she had continued using her (ventilator) ... things would be different, and she didn't get to get there.

"Almost all of the coverage supported her death. That's what's wrong."

Ford said it's difficult from the outside to understand a person's life and level of suffering.

"(Jerika) went through a lot," Caplan said. "She knows more about that than many people weighing in on what should happen."

Caplan said Jerika's story didn't take on the dimension of Terry Schiavo, a Florida woman who remained in a "persistent" vegetative state for 15 years, or Brittany Maynard, a 29-year-old with brain cancer who relocated to Oregon so she could legally kill herself with medication.

"(Jerika) was saying, 'I've been through so much. I don't want to do this anymore,' " Caplan said. "Which is an important question, but it isn't quite analogous to what happens either when someone requests help in dying or says, 'I don't want to be maintained because I'm so old and so frail that there's no point.' She was in a different situation."

More: Q&A: What you should know about right to die

More: Child neglect claimed in teen's plan to end her own life

Caplan said Americans are "completely and utterly confused" about right-to-die issues, including how to deal with mental impairment in dying, whether to honor a child's request and even what constitutes death.

"Where views diverge is saying how much suffering is too much to ask someone to bear, and whose responsibility is it to partake in ending a life if it's more suffering than anyone ought to bear," Ford, the Cleveland Clinic ethicist, said.

One of those issues is physician-assisted suicide. Public opinion about the practice remains divided: a 2013 Pew Research Center survey found that 47% of Americans approve of laws to allow the practice for the terminally ill, while 49% disapprove.

Five states California, Colorado, Oregon, Vermont and Washington and Washington, D.C., have legalized the practice, and Montana recognized it following a state Supreme Court ruling.

Ford said there was "a great energy among states" to continue the legislation for terminally ill adults a year ago.

More: Teen's plan to die has disability groups seeking intervention

More: More than a thousand people turn out for prom of Wisconsin teen choosing to die

"Those have sort of taken a backseat, recently," he said.

Earlier this year, Wisconsin State Rep. Sondy Pope introduced legislation, modeled closely after other physician-assisted suicide laws, that would allow terminally ill Wisconsin adults to receive medication to end their lives.

Pope, who conceded that the legislation has no immediate chance of becoming law, said she would support legislation to allow a minor who isn't terminal to die with "very, very thoughtful safeguards that include input from loved ones."

"That's way down the road in a case-by-case individual basis ... It doesn't seem right, morally, to say, 'I'm sorry. You're not 18. You have to suffer.' "

Follow Ethan Safran on Twitter:@EthanSafran

More: Girl, 14, with incurable disease makes heartbreaking decision to die

Read or Share this story: https://usat.ly/2xGUAiA

Originally posted here:
Year after Jerika Bolen's death, debate continues on right-to-die issues - USA TODAY