Stem Cell Clinic

Asymmetrex’s Head Will Lead Discussion on Supplying Private Stem Cell Clinics at the 6th Annual Clinical Trial … – PR Web (press release)

Time to Supply Private Stem Cell Clinics?

Boston, MA (PRWEB) March 07, 2017

Recent scientific reports put the number of private clinics offering stem cell medical treatments in the U.S. at greater than 400. More than 300 of these clinics emerged since 2009. They mirror the rapid increase in FDA-approved clinical trials during the same period at a rate of about 300 new therapy-focused adult tissue stem cell trials each year. However, because of the inherently small number of patients enrolled in early clinical trials and the much larger number of patients seen in medical clinics, the number of stem cell treatments performed in private clinics dwarfs the number in clinical trials by more than 10-fold.

In both settings, treatment cell transplants per se appear generally safe, as long as proper care is given to other routine safety factors, which include mainly keeping treatments free of infectious agents and chemical contaminants and avoiding immune reactions. These safety procedures fall well within the training and expertise of physicians in private clinics, as well as in hospital-based clinical trials.

The rapid growth of private stem cell clinics has alarmed some stem cell scientists and their member organizations. The clinics are accused of making false claims, exploiting patients pain and distress for financial gain, and generally harming the reputation of stem cell science. In contrast, in FDA-approved clinical trials, patient volunteers are necessarily informed that their treatments are experimental, and therefore may bring them no medical benefit. Generally, trial subjects do not pay for their treatment, though often treatment costs are covered by their personal health insurance.

Asymmetrexs founder and director, James L. Sherley, M.D., Ph.D., recently began a public discourse, in which he argues that in the important respects private stem cell clinics are not all that different than FDA-approved clinical trials. First, he says that glibly painting all several hundred or more private stem cell clinics as exploitive is an unsubstantiated claim itself. Generally, physicians in both settings are diligently looking for ways to improve the health of patients clinical trial physicians in the more distant future and private clinic physicians immediately. Sherley, a physician scientist, stresses the importance of recognizing medical empiricism as an important contributor to the advance of modern medicine and medical science.

At the conference, Sherley is scheduled to lead a panel discussion on the topic on March 8 at 15:50 PM (EDT) and give a talk on March 9 at 13:30 PM (EDT). A major new position he will present is that the volume of stem cell treatments now occurring in private clinics is much too large to simply disparage and attempt to shut down. Working to improve the quality of private stem cell clinic treatments for patients and to improve their documentation towards accelerating progress in stem cell medicine is a better goal.

To attendees at this weeks Clinical Trials Supply conference, Sherley will suggest that the supply of private stem cell clinics with high quality, certified sources of stem cells is an underappreciated crucial need for advancing stem cell medicine. The companies that are able to mobilize to fill in this supply gap could have a 10-fold greater impact on advancing stem cell medicine compared to their current minimal impact in FDA-approved stem cell clinical trials.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrexs founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The companys patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Currently, Asymmetrexs focus is employing its technological advantages to develop and market facile methods for monitoring adult stem cell number and function in stem cell transplantation treatments and in pre-clinical assays for drug safety.

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Asymmetrex's Head Will Lead Discussion on Supplying Private Stem Cell Clinics at the 6th Annual Clinical Trial ... - PR Web (press release)

A Cure for Cancer? How CAR-T Therapy is Revolutionizing Oncology – Labiotech.eu (blog)

CAR-T has been hailed as a cure for cancer, butwhat really is this miraculous technology and what can we actually expect when it reaches the market?

The field of immuno-oncology is booming with billions of euros in investment. The ability to rewire our own immune system to fight cancer has certainly created huge expectations. After the success of the first checkpoint inhibitorson the market, many are turning their attention to CAR-T therapy,the next big cancer therapy to hit the market.

But is CAR-T therapy really a cure for cancer, as many seem to believe? Can the technology meet such high expectations? Are the recent deaths in clinical trials a sign that CAR-T is not ready for commercialization? What will the future bring?

To answer some of the most burning questions, Italked with some of the leaders in this field to draw an overview of the current state of the field.

CAR therapy is at the same time cell therapy, gene therapy, and immunotherapy.It represents a radical departure from all forms of medicine in existence until now, Michel Sadelain, co-founder of Juno Therapeutics, told The Scientist.

A CAR-T therapy consists in the infusion of engineered T-cells that express a Chimeric Antigen Receptor (CAR) on their cell membrane. This receptor counts with an externaltarget-binding domain designed to recognize a specific tumor antigen and an internalactivation domain responsible for activating the T-cell when the CAR-T binds its target. Second and third generation CAR-Ts have additional costimulatory domains that further enhance the immune response.

The most common procedure for CAR-T therapy consists in the extraction of T-cells from the own patient, which are then genetically modified and expanded in vitro. Finally, they are reinfused into the patient ready to fight the tumor.

Checkpoint inhibitors have already been incredibly successful. The drugs inhibitthe mechanism that tumor cells use to inhibit T-cell activity and overcome the immune system. CAR-T goes one step further and engineers the T-cell itself to enhance the immune response against a specific tumor antigen.

CAR-T clinical trials have shown huge remission rates, of up to 94% in severe forms of cancer, which is particularly impressive considering most of the trials recruit patients that have not responded to all other available treatments for their form of cancer.These preliminary results have fed the expectations of patients and investors alike, but its important to remember that the therapy also has flaws.

Im just trying to be realistic, CAR-T is not the miracle cure for cancer, Andr Choulika, CEO of Cellectis,told us.CAR-T therapy has in fact been linked tosevere side-effects, such as neurotoxicity and cytokine release syndrome.The recent report of several deaths in CAR-T trials made many realize that the technology might not be as perfect as many had originally expected.

These results mostly come from the most studied application of CAR-T, which targets the CD19 antigen found in B-cells.The companies leading the development of CAR-T all target the CD19 antigen to treat B-cell malignancies, which include several forms of lymphoma and leukemia.

The initial furor and excitement of CAR-T hasled to extensive and rapid clinical development in the CD19 target space, saysDavid Gilham, R&D VP at Celyad. Research is busy catching up at the moment, in particular concerning toxicity. The lack of good preclinical models hampers this work, but with clinical samples available, ongoing investigations are now closer to identifying the underlying mechanisms and further refining the approach.

There are several companies competingto be the first tomarket. Competition is tight and the results of a clinical trial can change everything.Juno Therapeutics, whichused to lead the race has just announced the termination of its lead CAR-T program after a total of 5 patients died of cerebral edema caused by the therapy. The company had created huge expectations, and itmarket cap reached over 2.5Bn only 3 years after its inception.

In terms of clinical development, Novartis seems to be leading now. In November, the company recently presented results from a Phase II trial with its CAR-T candidate CTL019 for B-cell acute lymphoblastic leukemia (ALL), which achieved remission in 82% of patients after 3 months. The company is preparing to submit applications to the FDA and EMA this year, despite 50% of patients in the trial were reported to present severe side-effects.

Kite Pharmajustreportedresults from a Phase II clinical trial with its lead candidate, axicabtageneciloleucel, previously KTE-C19. The therapy managed to keep 36% of patients with lymphoma clear of the disease after 6months, which made Kites shares jump by 16%. However, this ongoing trial has already reported three deaths, two of them linked to the CAR-T therapy.Hoping to get ahead of Novartis, Kite Pharmastarted regulatory submissions with the FDAin December.

Despitesevere side-effects and several deaths in clinical trials, some argue that CAR-T therapy is worth the risk when a patient has not responded to any other available treatments. But others are already developing improved versions of CAR-T that are safer for the patients.

Cellectis originally developed UCART19, now licensed to Servier and Pfizer. Its a CAR-T therapy with a switch control system that only activates the engineered cells when rapamycin is present. The therapy is in Phase I and has already saved two babies with aggressive forms of leukemia. Bellicum Pharmaceuticals, in the US, is developing a similar technologycalled GoCAR-T that requiresrimiducid for CAR-T cell activation.

For its part, Celyad is developing a version of CAR-T that makes T-cells express Natural Killer Receptors (NKRs).Its disruptive because NKR-2 binds to 8 different ligands that are expressed on above 80% of solid and hematological malignancies, said Christian Homsy, CEO and co-founder of Celyad.Weve started one of the largest and broadesttrials in the sector, targeting 7 indications.

Targeting solid tumors is a big challenge in the field of immuno-oncology. Low T-cell infiltration and an immunosuppressive environment prevent the immune system from effectively attacking solid tumors. Bluebird bio and Celgene are developing their own CAR-T technology for solid tumors from the US.

Others think that the way to go for CAR-T is combination therapies. We are excited about combining checkpoint inhibitors such as PD-1 inhibitors and anti-CTLA4 drugs with CAR-T cells, said Zelig Eshhar, pioneer of the CAR-T technology at the NIH, for The Scientist.

Most approaches to CAR-T engineer the patients own cells, but this process requires several weeks and is expensive. Some estimates for the therapys price go over 500,000. A possible solution is allogeneic CAR-T therapy, i.e. sourced from a healthy donor and ready to go when the patient needs it.

Cellectis and Celyad are developing their ownallogeneic CAR-T each, and theres friction between them both. In this area, Celyad is still in preclinical phase, while Cellectis UCART123 recently received FDA approval to start clinical trials, making it the first study for allogeneic CAR-T in humans.

The technology promises a faster and cheaper approach to CAR-T, but developing an off-the-shelf therapyis a scientifically challenging avenue according to Celyads CEOChristian Homsy.

I doubt that allogeneic CAR-T can be a real off-the-shelf therapy, he commented. There are still some significant scientific challengeswith regards to immunology, as well as manufacturing, transportation, traceability and banking solutions necessary to reach the scale needed for widespread patient treatment.

As you can appreciate, theres plenty going on in the CAR-T space. The technology is not perfect yet, but it offers hope for patients that had none before. Whoever makes it first to the market will open the way for better alternatives to come in the next years.

Images from CI Photos /Shutterstock; Kite Pharma;Klebanoff et al. (2014) Nature Reviews Clinical Oncology 11, 685686;Bellicum Pharmaceuticals

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A Cure for Cancer? How CAR-T Therapy is Revolutionizing Oncology - Labiotech.eu (blog)

United States Market Report for Orthopedic Cell Therapy 2017 – Research and Markets – Business Wire (press release)

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "US Market Report for Orthopedic Cell Therapy 2017 - MedCore" report to their offering.

There has been much greater interest in bone marrow concentration for use in spinal fusions compared to platelet-rich plasma. The platelet-rich plasma market, on the other hand, is expanding into soft tissue indications. While bone graft substitutes can be soaked in PRP or bone marrow concentrate as an application, the most rapidly growing application, especially for platelet-rich plasma, is for injectables. Such products are directly injected into the site, for example, in a ligament repair or wound operation.

Competition over price is the reason the market values for these segments are not growing as quickly as might be expected. Arthrex significantly brought down the ASP for the market when they introduced their ACP platelet concentration system, but prices have now largely stabilized in the PRP segment. Test-tube-based products allow for concentration of smaller volumes; these systems reduce ASP further as customers can shift away from higher ASP disposable bucket products.

Key Topics Covered:

1. Research Methodology

2. Disease Overview

2.1 Basic Anatomy

2.2 Disease Pathology And Disorders

2.3 Patient Demographics

3. Product Assessment

3.1 Product Portfolios

3.2 Regulatory Issues And Recalls

3.3 Clinical Trials

4. Orthopedic Cell Therapy Market

4.1 Introduction

4.2 Market Overview

4.3 Market Analysis And Forecast

4.4 Drivers And Limiters

4.5 Competitive Market Share Analysis

Companies Mentioned

For more information about this report visit http://www.researchandmarkets.com/research/796hhz/us_market_report.

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United States Market Report for Orthopedic Cell Therapy 2017 - Research and Markets - Business Wire (press release)

Researchers Engineer Enforcer Cells That Will Take out Lethal Bacteria – Big Think

Bacteria and antibiotics have been in an arms race since the drugs were invented. But for economic reasons, fewer and fewer of these drugs are being developed today, while the fear of antibiotic-resistant bacteria is ever-growing. This, and the potential threat of a bioterror attack, where say an epidemic-causing bacteria is released into the general population, makes the need for countermeasures obvious. Johns Hopkins researchers have come up with a new way to eliminate dangerous bacteria, using beefed up cells who seek out and destroy dangerous pathogens, all on their own.

Researchers from the John Hopkins Whiting School of Engineering and the School of Medicine teamed up on this four-year project. They received a grant of $5.7 million, awarded by the federal agency DARPA (Defense Advanced Research Projects Agency). The point of the study is to create a biocontrol system that can send out single-cell enforcers to find and eliminate certain pathogens. Researchers will program amoeba cells to do so, each one micron long, about one-tenth the width of a human hair.

These amoeba are independent and travel on their own surfaces--meaning they can get potentially deadly pathogens wherever they may be. In the event they are needed, they would be emitted through a spray. As a first step, scientists hope to program the cells to go after the bacteria which causes Legionnaires disease.

It could also be used to target Pseudomonas aeruginosa, a dangerous, potentially deadly, treatment-resistant strain of pneumonia. In another scenario, specially engineered amoeba cells are unleashed by health officials if an outbreak occurs. There are other uses too. They could sterilize instruments, and studying them may even reap benefits for cancer research.

So whats DARPAs interest? These biochemical warriors may someday help dampen down or even counteract a bioterror attack. They could also be used to render contaminated soil harmless. The innovation here is that each cellular soldier is self-directed. It does not depend on an outside human operator. Principal investigator Pablo A. Iglesias likened it to a self-driving car. Iglesias is a professor of electrical and computer engineering at Johns Hopkins.

Amoebas.By C.G. Ehrenberg (Die Infusionthierchen, 1830) [Public domain], via Wikimedia Commons

Just as cruise control slows down or speeds up a car, Iglesias said, In a similar way, the biocontrol systems were developing must be able to sense where the pathogens are, move their cells toward the bacterial targets, and then engulf them to prevent infections among people who might otherwise be exposed to the harmful microbes.

Iglesias started looking into biocontrol systems 15 years ago. To develop this particular type of synthetic biology, he is teaming up with four colleagues at the school of medicine. Each is a biological chemistry expert. Douglas N. Robinson, a professor of cell biology is on the team. He likened what these amoebas do to bacteria to what humans do when they encounter freshly baked cookies. They seek to gorge themselves unabashedly.

Though the technique has a lot of potential, Iglesias admitted to the Baltimore Sun, that past experiments in the field havent actually gone very well. "People manage to do things but it takes huge amounts of effort and it's more or less random, he said. There has to be a lot of iterations before it works." Other experts say, this teams efforts are heartening, particularly due to the growing menace of antibiotic-resistant bacteria.

Researchers are using amoeba cells called Dictyostelium discoideum in their experiments. This species is commonly studied. It can be found in the damp soil of riverbeds. These microbes surround bacteria and devour them. Turns out the bacteria let off a biochemical scent that the amoeba, using a specific type of receptor, pick up.

Robinson said that their experiments must adhere to the strictest operating protocols, lest such amoeba escape into the environment and wreak havoc. If this project bears fruit, researchers believe theyll have a new tool to fight infection in hospitals, and protect society against bioterror and ecological disasters. So far, scientists are targeting only pathogens lurking outside the human body. In this contract, we are not targeting bacteria in human blood, Iglesias said. But the hope is that the techniques we develop would ultimately be useful for that.

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Researchers Engineer Enforcer Cells That Will Take out Lethal Bacteria - Big Think

Stem Cell Therapy – Premier Regenerative Stem Cell

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