Monthly Archives: March 2017

The Re-Brand Premier Regenerative Stem Cell and Wellness Centers, recently rebranded their business from Premier Stem Cell Institute, in response to expanding locations, technology, and treatments. This move reflects the growth and success this company has undergone recently and goals for the future.

PRSC and Wellness Centers President, Kandace Stolz said, This rebrand is the culmination of the years of work weve put into stem cell medicine. Were growing and healing more patients than we ever have before, this new name reflects those accomplishments and gives us room grow. We are so thrilled for this move and cant wait to do even more for our patients going forward.

Premier Regenerative Stem Cell and Wellness Centers will continue to partner with the NFL Alumni Association and treat current and former professional athletes. PRSC remains dedicated to studying stem cell treatment by collecting and tracking data to further stem cell progress and maximize results for all patients. PRSCs commitment to being a leader in stem cell and regenerative medicine is unwavering and will continue to innovate and learn to heal and improve the quality of life for all patients.

About Premier Regenerative Stem Cell and Wellness Centers: PRSC is a leading research and treatment facility in Colorado, providing innovative medicine and therapies for those in pain by harnessing the bodys own natural healing power of stem cells. As team of cutting-edge medical experts, PRSC is dedicated to treating patients by using their own stem cells to heal, improve quality of life, and battle the acute pain of chronic illnesses. Premier Regenerative Stem Cell and Wellness Center locations include Loveland Colorado, Dallas Texas, St. Louis, Missouri, and Jacksonville, Florida. PRSC has plans to expand to other major cities across the United States in the near future.

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Stem Cell Therapy - Premier Regenerative Stem Cell

In this May 2016 photo provided by Kite Pharma, cell therapy specialists at the company's manufacturing facility in El Segundo, Calif., prepare blood cells from a patient to be engineered in the lab to fight cancer. The experimental gene therapy, called CAR-T cell, turns a patient's own blood cells into specialized cancer killers and worked in the study, with more than one third of very sick lymphoma patients showing no sign of disease six months after a single treatment, its maker said Tuesday, Feb. 28, 2017. (Kite Pharma via AP)

An experimental gene therapy that turns a patient's own blood cells into cancer killers worked in a major study, with more than one-third of very sick lymphoma patients showing no sign of disease six months after a single treatment, its maker said Tuesday.

In all, 82 percent of patients had their cancer shrink at least by half at some point in the study.

Its sponsor, California-based Kite Pharma, is racing Novartis AG to become the first to win approval of the treatment, called CAR-T cell therapy, in the U.S. It could become the nation's first approved gene therapy.

A hopeful sign: the number in complete remission at six months 36 percent is barely changed from partial results released after three months, suggesting this one-time treatment might give lasting benefits for those who do respond well.

"This seems extraordinary ... extremely encouraging," said one independent expert, Dr. Roy Herbst, cancer medicines chief at the Yale Cancer Center.

The worry has been how long Kite's treatment would last and its side effects, which he said seem manageable in the study. Follow-up beyond six months is still needed to see if the benefit wanes, Herbst said, but added, "this certainly is something I would want to have available."

The therapy is not without risk. Three of the 101 patients in the study died of causes unrelated to worsening of their cancer, and two of those deaths were deemed due to the treatment.

It was developed at the government's National Cancer Institute and then licensed to Kite. The Leukemia and Lymphoma Society helped sponsor the study.

Results were released by the company and have not been published or reviewed by other experts. Full results will be presented at the American Association for Cancer Research conference in April.

The company plans to seek approval from the U.S. Food and Drug Administration by the end of March and in Europe later this year.

The treatment involves filtering a patient's blood to remove key immune system soldiers called T-cells, altering them in the lab to contain a gene that targets cancer, and giving them back intravenously. Doctors call it a "living drug" permanently altered cells that multiply in the body into an army to fight the disease.

Patients in the study had one of three types of non-Hodgkin lymphoma, a blood cancer, and had failed all other treatments. Median survival for such patients has been about six months.

Kite study patients seem to be living longer, but median survival isn't yet known. With nearly nine months of follow-up, more than half are still alive.

Six months after treatment, 41 percent still had a partial response (cancer shrunk at least in half) and 36 percent were in complete remission (no sign of disease).

"The numbers are fantastic," said Dr. Fred Locke, a blood cancer expert at Moffitt Cancer Center in Tampa who co-led the study and has been a paid adviser to Kite. "These are heavily treated patients who have no other options."

One of his patients, 43-year-old Dimas Padilla of Orlando, was driving when he got a call saying his cancer was worsening, chemotherapy was no longer working, and there was no match to enable a second try at a stem cell transplant.

"I actually needed to park ... I was thinking how am I going to tell this to my mother, my wife, my children," he said. But after CAR-T therapy last August, he saw his tumors "shrink like ice cubes" and is now in complete remission.

"They were able to save my life," Padilla said.

Of the study participants, 13 percent developed a dangerous condition where the immune system overreacts in fighting the cancer, but that rate is lower than in some other tests of CAR-T therapy. The rate fell during the study as doctors got better at detecting and treating it sooner.

Roughly a third of patients developed anemia or other blood-count-related problems, which Locke said were easily treated. And 28 percent had neurological problems such as sleepiness, confusion, tremor or difficulty speaking, but these typically lasted just a few days, Locke said.

"It's a safe treatment, certainly a lot safer than having progressive lymphoma," and comparable to combination chemotherapy in terms of side effects, said the cancer institute's Dr. Steven Rosenberg, who had no role in Kite's study. The first lymphoma patient Rosenberg treated this way, a Florida man, is still in remission seven years later.

There were no cases of swelling and fluid in the brain in this or any other study testing Kite's treatment, company officials said. That contrasts with Juno Therapeutics, which has had a CAR-T study put on hold twice after five patient deaths due to this problem.

Company officials would not say what the treatment might cost, but other types of immune system therapies have been very expensive. It's also being tested for some other types of blood cancer.

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Online:

Lymphoma info: http://seer.cancer.gov/statfacts/html/nhl.html

CAR-T therapy: http://www.cancer.gov/about-cancer/treatment/research/car-t-cells

Gene therapy: http://ghr.nlm.nih.gov/primer/therapy/availability

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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP .

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New gene therapy for cancer shows promise in major test - Colorado Springs Gazette

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T. LOUIS When red blood cells are poured into the test tubes here in Dr. Allan Doctors lab, tiny tools measure the reaction of the rabbit aortas strung up inside, computing if and how strongly the aortas constrict. Doctor and his team are trying to make sure that when they dump in the artificial blood theyre developing, the aortas react the same way.

The experiments being conducted on a recent day were not only just a few of the many the team will need to run before testing their blood substitute in people, but were also early steps to show that their design, with any luck, can steer them beyond the decades of failure in the field.

There has been about 50, 60 years of research in trying to make a blood substitute that has not worked, said Doctor, a pediatric critical care physician and researcher at Washington University in St. Louis.

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The need for such a product is clear. Blood loss from traumatic injuries is responsible for thousands of deaths annually, and even when people survive, oxygen depletion can leave tissue permanently injured. Fresh blood can only be stored for 42 days, and only lasts for a few hours unrefrigerated. A substitute could be vital in settings like battlefields or rural areas without easy access to blood, used as a stopgap measure to keep the injured alive until they get to a hospital.

But the quest to develop substitute blood has bedeviled researchers in academia, the military, and the biopharma industry, with several companies including Baxter, Northfield Laboratories, and Biopure abandoning theirattempts.

The artificial blood researchers have been trying to cook up is not a true substitute, in that it wouldnt perform all of bloods functions, but rather provide a means to deliver oxygen throughout the body.

One key problem: Hemoglobin, the protein in red blood cells that carries oxygen from the lungs to needy tissues, can damage tissue and cause blood vessels to constrict. Thats one reason why hemoglobin is contained in cells to isolate it and its toxic iron.

Any successful blood substitute will need to transport and deliver oxygen, while staving off the threat hemoglobin poses.

In past attempts, scientists have tried to tweak hemoglobin to make it safer, but so far, no blood substitute has been approved for use in the United States or Europe. (One substitute, Hemopure from HbO2 Therapeutics, is used in South Africa, and a clinical trial of a stem cell-based substitute is expected to begin this fall in the United Kingdom.)

But instead of trying to engineer hemoglobin, Doctor and his colleagues have encased it in a synthetic polymer designed by one of Doctors collaborators, Dipanjan Pan of the University of Illinois, Urbana-Champaign.

They hope the case will ensure that their substitute blood, called ErythroMer, wont cause a tightening in the blood vessels, whichincreases the risk of heart attack and stroke.

At the same time, ErythroMer detects where oxygen should be delivered based on the pH level of the blood, moving oxygen from the lungs to where its most needed like a junkyard magnet picking up a car in one spot and dropping it elsewhere.

If its successful, ErythroMer could be freeze-dried into a powder and stored safely for years, so that when its needed, it can be mixed with sterile water and administered. Its designed to be immune silent so that the immune system doesnt attack it and it could be given to people of any blood type.

Scientists not working on ErythroMer said it appears to be an improvement in some respects over earlier candidates, but note that it is not the first to attempt enclosing hemoglobin in various materials. So far, no one has cracked the code of creating an artificial blood, and its not clear this group will either.

Its not as easy as it sounds, said Dr. Ernest Moore, the vice chair of trauma and critical care research at the University of Colorado, Denver, who has helped run clinical trials of other substitutes.

One concern for Mark Scott, a senior scientist at Canadian Blood Services, is the tininess of ErythroMer. Each particle is about one-fiftieth the size of a normal red blood cell, and Scott said that increased the risk that it could leak from the bloodstream into surrounding tissue. And when someone loses a lot of blood and goes into shock, their blood vessels only become more leaky, Scott said.

Pentagon hopes to use foam, injected through belly button, to save bleeding soldiers

These are all things that you really have to be concerned about, said Scott, who also works at the Center for Blood Research at the University of British Columbia. Is the size going to lead to a lot of vascular leakage? Is the hemoglobin thats inside the shell stabilized so it wont cause acute or chronic toxicity?

One advantage of the small size of the substitute blood, both Scott and Doctor said, is that it could be used for people with sickle cell disease. During sickle cell crises, the misshapen red blood cells gum up blood vessels, and its possible that ErythroMer could get around the logjams and deliver oxygen past those points. Doctor also raised the idea that it could be used to oxygenate organs during transplant operations.

In addition to overcoming the biological hurdles, the ErythroMer team will eventually have to convince regulators that itsproduct is safe enough to test in people (depending on its success in animals, that is). Several scientists said the Food and Drug Administration seems hesitant to green-light new trials of blood substitutes and some said rightfully so because of safety concerns from past products. Plus, clinical trials of trauma-related treatments often run into ethical quandaries about informed consent.

In an email, an FDA spokeswoman said that studies on these types of products have found they are not safe or effective, but that the agency recognizes they potentially could be lifesaving in situations where blood transfusion is necessary, but blood is not available or cant be used. She said future clinical studies remain possible.

Still, human studiesare a long ways away, the researchers acknowledge. So far, Doctor and his team, whose work has been supported by the Department of Defense, have presented results from rodent studies at a scientific conference. And they have their own questions about how ErythroMer will perform as they test it in larger animals, first in rabbits: Does it damage other cells in the bloodstream? Does it interfere with the clotting process?

The team has formed a company called KaloCyte (Greek for good cell) to make the substitute for further studies. Doctor likened it to moving the production from a craft brewery scale so far, Doctor said, its been lovingly made by graduate students, batch by batch to the scale and standards of another St. Louis blend, Budweiser.

Andrew Joseph can be reached at andrew.joseph@statnews.com Follow Andrew on Twitter @DrewQJoseph

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Artificial blood: the quest for one of science's holy grails - Stat - STAT