StemCell Therapy

When embryonic Stem Cell therapy was first discovered in 1998, it changed the face of medicine. The idea of being able to regenerate and replace damaged cells seemed futuristic at the time, yet today such treatments are commonplace. Now, science has taken another quantum leap this time into the nano-sized world of exosomes, tiny bubbles that grow out of cell walls and contain much of the information contained within the cell including Growth factors, microRNA and messenger RNA. Mesenchymal stem cell (MSC) exosome therapy is currently one of the hottest trends in regenerative medicine, one that patients at AM Medical in Yelm can now experience.

Everyone has heard of stem cell therapy, but it turns out that its not the stem cells that are doing the work, says Dr. Ana Mihalcea, President of AM Medical. Its the exosomes that carry the information of regeneration. Infused stem cells, attach to blood vessel walls, and then give off exosomes.

Exosomes have several key differences from stem cells; they do not get removed from the circulation like stem cells, which are in the body for less than 72 hours before they get destroyed by the immune system; they do not produce a rejection reaction because they are not a cell and contain no DNA, and they pass the blood brain barrier, Mihalcea notes. In a study on stroke scientists fluorescently tagged exosomes, and the infused exosomes went exactly to the region where the stroke had occurred, she adds. The same was not true of stem cells as they do not cross the blood brain barrier.

As a result of their powerful cargo, exosomes can be used to address a multitude of conditions, including arthritis, autoimmune disorders, cardiovascular and neurogenerative diseases like Parkinsons and Alzheimers. Old cells can be reprogrammed by MSC exosomes as the target cells can transcribe the microRNA into functional proteins. Just like a virus, the exosome information of the young stem cells can infect the old cells with Youth, explains Mihalcea.

Spinal cord injuries are an area in which exosomes have produced dramatic results. Mihalcea cites the example of Dr. Douglas J. Spiels Interventional Pain Specialty Practice in NJ. Dr. Spiel has been able to rehabilitate spinal cord injuries with Exosome infusions into the spine and intravenously, she says. After several weeks, hes had patients regain muscle strength and sensation. These are prolonged, ongoing regenerative effects that continued to improve for months after the infusion.

When it comes to autoimmune diseases, inflammation plays a key role. Again, exosomes are able to reduce the problem by downregulating inflammation. TGF Beta 3 [Transforming growth factor beta-3] is the most important anti-inflammatory protein in the body and is abundant in MSC exosomes says Mihalcea. Many more Growth factors for blood vessel growth, neuronal and other tissue growth are present, allowing regenerative effects in all organ systems including skin wounds and burns.

The exosomes at AM Medical come from a laboratory in Florida that conducted pioneering research in the field. They come from perinatal mesenchymal stem cells and are scanned for any possible viruses to ensure their safety. Once harvested, the exosomes are concentrated so they can be infused in large doses.

For patients who qualify, the infusion process takes 10 to 15 minutes. Already, its been producing results for AM Medical patients. Weve had people with arthritis and chronic pain who had great responses, Mihalcea notes. There is an overall increase in wellbeing and sense of rejuvenation that is definitely noticeable.

Perhaps one of the largest sources of excitement over exosomes has to do with their anti-aging effects. Recently, ideas about the root causes of aging have been evolving, according to Mihalcea. Its been thought that aging occurs due to multiple different reasons like stem cell exhaustion, epigenetic changes, telomere shortening and others, she explains. It turns out that exosomes can modify almost all the hallmarks of aging. Theyre changing epigenetic expression to youthful function, and there are many potential applications. This is a new frontier in regenerative medicine that can help many people.

Learn more by watching Dr. Ana Mihalceas video on Exosomes The New Frontier Part 1: Longevity and Age reversal or reading further on the AM Medical website.

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Cutting Edge Exosome Regenerative Therapy Comes to Yelm's AM Medical - ThurstonTalk

WASHINGTON, Dec. 10, 2019 /PRNewswire/ -- A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for research at the National Institutes for Health (NIH) and expanded capacity at the Food and Drug Administration (FDA) to support this rapidly growing field. The report is based on insights shared by several leaders during a September 2019 event on Capitol Hill hosted by Alliance for Cell Therapy Now in collaboration with the Regenerative Medicine Foundation and the Cord Blood Association.

Regenerative cell therapies represent the next generation of treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, osteoarthritis, and wound healing. Several well-designed clinical trials are now being conducted under FDA-approved investigational new drug protocols. At the same time, some clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this promising field.

The 21st Century Cures Act contained several provisions to make safe and effective regenerative cellular therapies available to patients, and the FDA and the NIH have taken several steps to advance and support the field. However, additional actions are needed to help bring safe and effective therapies to patients.

Leaders representing FDA, NIH, the Duke University School of Medicine and Cord Blood Association, the Georgia Institute of Technology, the Marcus Foundation, the Regenerative Medicine Foundation, Sanford Health, the Wake Forest Institute of Regenerative Medicine, and Alliance for Cell Therapy Now, participated in the event.

To read the entire report, go to http://allianceforcelltherapynow.org/wp-content/uploads/2019/12/Regenerative-Cell-Therapies-Alliance-for-Cell-Therapy-Capitol-Hill-Briefing-Sept-2019-1.pdf

To view speaker slides and a webcast of the event, visit http://allianceforcelltherapynow.org/events/.

SOURCE Alliance for Cell Therapy Now

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New Report Calls for Measurement of Outcomes and Federal Funding for Research and Increased Capacity at FDA to Advance Safe and Effective Regenerative...

Based on promising results in an early clinical trial, Mayo Clinic has formed a new joint venture with materials engineering firm W.L. Gore & Associates to spearhead a new therapy using stem cells to repair a painful tissue problem stemming from Crohn's disease.

Mayo and Gore on Tuesday announced the formation of a for-profit company called Avobis Bio ("a vobis" is Latin for "by you"), based in Delaware, where Gore is also based. The privately held company will draw on the expertise of scientists at Mayo and Gore to launch a second-phase clinical trial in the hopes of eventually offering the treatment commercially.

A laboratory director at Mayo Clinic said Avobis Bio's therapy, if successful, may be a first-of-its-kind in health care, involving the delivery of a person's own mesenchymal stem cells on a synthetic "scaffold" that biodegrades over time, eventually leaving behind only native tissue sealing a wound. The first application of the technology is treatment of a health problem called perianal fistulae. But if successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials.

"This is a completely new approach, where we are trying to leverage what the body can do for itself," said Allan Dietz, co-director of the Human Cell Therapy Lab in Mayo's Center for Regenerative Medicine.

Mesenchymal stem cells can naturally convert into other kinds of tissue, like muscle or bone. For the Avobis Bio therapy, the cells are harvested from a biopsy of a person's body fat and cultivated at a Mayo laboratory to high purity. No one knows whether the cells deposited into the wound directly convert into scar tissue, or if the stem cells trigger genetic signals that cause other cells in the surrounding tissue to begin the healing process.

"We provide stem cells in the right frame, at the right time, for the body to recognize the signals that it should begin the healing process," Dietz said. "I think in some ways, it was a required simple first step but it appears to be a major step."

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs. Mayo has used Gore-made devices for many years.

Several years ago, physician-researchers at the not-for-profit Mayo Clinic in Rochester grew keenly interested in a Gore device called the Bio-A Fistula Plug, a flexible bioabsorbable plug made from a material similar to dissolving stitches.

The plug can be used to repair unnatural canals that form between a person's anal canal and their outer skin, after Crohn's disease weakens surrounding tissues. These canals, also known as perianal fistulae, are painful, disruptive and difficult to treat, doctors said. For patients with Crohn's disease, lifetime incidence of perianal fistulae ranges between 23% and 38%, according to past studies.

In 2017, Mayo announced first-in-human results of their experimental therapy treating Crohn's patients' perianal fistulae using a Gore Bio-A Fistula Plug coated with the patient's own stem cells. The study, run in consultation with the Food and Drug Administration, provided the open-label treatment to a small group of patients whose fistulae had not responded to treatment for a median time of six years.

After initial results proved encouraging, the trial eventually enrolled 20 people. Of the 19 who remained in the trial for at least a year, 76% experienced healing of their fistulae, according to results announced by researchers but not yet published in a journal. If validated in a larger clinical trial, that rate of healing would be dramatically better than outcomes under existing treatments, the companies said.

"We have done work in the past looking at combining cells and materials. For us, the clinical trial results from Mayo were incredibly compelling," said Tiffany Brown, a Gore employee and general manager of Avobis Bio. "It is a challenge to translate how cells behave in the lab to how they will behave in patients. So having that proof in real patients really got the conversation going on how we could work together."

If the therapy is proved safe and effective in larger trials, Brown said about 50,000 Crohn's patients per year could be eligible to get it for perianal fistulae. Although Gore is phasing out general sales of its Bio-A Fistula Plug, the device will be supplied exclusively to Avobis Bio.

Mayo and Gore declined to reveal financial details for Avobis Bio, except to note that both parties are contributing to the limited-liability joint venture. The company has a five-member board of managers, with Mayo appointing two members and Gore appointing three.

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Mayo Clinic, maker of Gore-Tex outerwear are teaming up in Crohn's fight - Minneapolis Star Tribune

(Reuters) - Privately held drug developer Enzyvant said on Thursday the U.S. Food and Drug Administration declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing.

The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system.

The health regulator in a letter to Enzyvant raised questions about the manufacturing process for the treatment as well other issues based on its inspection of the manufacturing site, the company said.

Many of these are topics that we are very aware of and we anticipated those to be post-marketing commitments, not approval requirements, Chief Executive Officer Rachelle Jacques told Reuters on a phone call.

The good news is theres no requirement for us to foresee any additional animal studies or any additional clinical trials.

The company said it had planned to manufacture its treatment through a third-party manufacturer.

If approved, RVT-802 would have been the first to win an FDA nod under the agencys Regenerative Medicine Advanced Therapy (RMAT) designation, granted to drug developers making regenerative therapies for conditions lacking treatment options.

Babies born with congenital athymia - about 17 to 24 cases in the United States every year - usually do not survive beyond the age of two.

RVT-802 is a tissue-based therapy, manufactured by sourcing thymus tissue from infants undergoing heart surgeries unrelated to congenital athymia, and administered only once.

Ten clinical studies spanning over two decades and 85 patients were conducted at North Carolinas Duke University, where the treatment was developed.

Enzyvant is currently owned and entirely funded by Swiss drug developer Roivant, but will become here a subsidiary of Japan-based Sumitomo Dainippon in a deal expected to close next year.

We would anticipate that the deal would close before we could fully address the issues in the (FDA letter), Jacques said.

Reporting by Vishwadha Chander and Tamara Mathias; Editing by Maju Samuel and Shinjini Ganguli

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FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns - Reuters

Policymakers around the world are determining how to apply existing regulations to 3D organ printing.

When Selena Gomez suffered from Lupus, her best friend Francia Raisa donated her kidney to her, saving Gomezs life. For decades, people just like Gomez have escaped death due to heroic organ donations, either from living or deceased donors.

Today, 3D printingalso referred to as 3DPmay revolutionize the practice of organ donation. Although 3D printing is currently used to make jewelry, food, and art, it may soon be used for medical solutions such as organ donations and bionic limbs.

As a result, policymakers around the world seek increased regulation of 3DP organs. Yet 3D bioprinting does not clearly fit into existing regulatory frameworks.

Since bioprinting generally falls within the regulatory domain of regenerative medicine, medical devices, and biologic drugs, regulators face the challenge of applying existing rules to this uncertain field. As of now, it is unclear whether policymakers can effectively regulate bioprinting under existing regulations, or if a new, specific regulatory process will be necessary.

In determining how to regulate 3D organ printing, policymakers must juggle many possible concerns. Since the technology is still developing, a lot of uncertainty remains about what the actual risks and ethical concerns are. For example, one ethical concern is that 3DP organs may be available to wealthy people only, while less affluent individuals will be blocked out from using these organs.

Another concern is safety. Since 3DP may require stem-cell technology, and the patients own cells may be used for replication, it is difficult to assess the safety risks. Stem-cell therapy cannot be tested on a large sample of healthy people, which limits effective clinical analysis. Also, 3DP biotechnology may open up new uses beyond 3DP organs, such as enhancement of human capacities for military use. Developers could use the technology to make military officers or even terrorists less vulnerable to injury in battle, but this would open up a whole new challenge for law enforcement and national security.

The U.S. Food and Drug Administration (FDA) focuses on the regulation of 3D printed organs. FDA so far has only released guidance on 3DP, and the recommendations do not cover bioprinting.

A significant concern in the United States is that 3D printed organs do not fit into any clear category of law. First, they are not organs because they are not born alive at any stage of development. Second, they are not drugs because drugs are used orally rather than through an invasive surgery, and drugs are primarily meant to relieve illness while donated organs may completely cure an illness.

Some policymakers in the United States propose regulating 3DP organs as a biological product, defined as a virus, therapeutic serum, toxinor analogous productapplicable to the prevention, treatment, or cure of a disease or condition of human beings.

Research company Biogelx suggests that biological products may be a promising category for printed organs. Within biological products, a 3DP organ is comparable to proteins because to print the organ, clinicians replicate healthy human cells, which include such proteins, says Biogelx. Although existing regulatory frameworks often compare 3DP organs to medical devices, Biogelx asserts that these organs should not be regulated as medical devices. Medical devices are not made of biological material and are often metal or plastic devices that help an individuals standard of life, but 3DP organs are different since they cause a chemical reaction in the body and have the purpose of wholly replacing an existing organ, says Biogelx.

International policymakers are also struggling to find a sufficient regulatory framework. In Canada, Health Canada released draft guidance last year to develop regulations for medical device manufacturers working towards bioprinting. Health Canada has several concerns about bioprinting, and it suggests that manufacturers looking for bioprinting licenses should be required to submit information regarding the use of additives in materials, the verification of the software for the bioprinting design, the method of sterilizing the machines, and the process of safe removal and reuse of bioprinting materials and residues.

Finally, Europes 3DP health technology is regulated by the European Medical Devices Directive, the Active Implantable Medical Devices Directive, and the Invitro Diagnostic Medical Devices Directive. The Medical Devices Directive categorizes bioprinting devices into several risk classes. Across the different classes, devices ranked as higher risk are subjected to third party assessment and more stringent requirements for clinical data. The highest risk class, implantable devices such as 3D organs, requires an independent design dossier review. A design dossier assesses risk, evaluates clinical data, and demonstrates the technologys compliance with regulations and requirements.

Although 3D printing of organs is right around the corner, policymakers around the world lack the information necessary to make regulatory decisions in this space. Different countries have different approaches, but many of the leading nations in 3DP share similar concerns. With more information, regulators will have to decide if existing regulatory frameworks can adequately address the safety concerns of 3D printed organs.

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The Uncertainty of Regulating 3D Organ Printing - The Regulatory Review

Circularity Healthcare, LLC Joins Forces with "Behind The Scenes" with Host Laurence Fishburne

MIAMI (PRWEB) December 11, 2019

Circularity is partnering with Telly Award-Winning "Behind the Scenes" to provide regular, ongoing, high-quality content from leading experts in a variety of fields with an initial focus on microcirculation science, regenerative medicine, and advanced wound healing and related symptoms.

"Behind The Scenes with Host Laurence Fishburne" is a public television series that has won numerous awards and delivers precision idea-telling at its best. Circularity is an innovative healthcare organization that is health-bent on their trademarked slogan: "Improving Lives by Improving Blood Flow." Their coming together to bring forward the ideas of modern health science on a stellar entertainment platform can only make for riveting content going forward. Viewers will find themselves in a win-win situation.

Watching informative content via this stylized venue will leave viewers feeling quite satisfied with their television watching experience. It is time well spent and information precisely delivered.

A Little More About Circularity

Circularity is concerned with bringing the very best in healthcare innovation to the public. In so doing, they have manufactured a product called D'OXYVA. This product has a two-pronged approach to health. First, it can be quite effective in reducing the debilitative effects of many of the diseases that are affecting the world today, such as COPD, diabetes, and cardiovascular illnesses. Secondly, Circularity's D'OXYVA can be used in a preventative capacity to improve microcirculation. The concept of microcirculation has far-reaching implications in neurology, oncology, endocrinology, cardiovascular health, respiratory health, dermatology, diabetic wound healing or diabetic wound care and other major fields.

Circularity Healthcare, LLC is the power behind D'OXYVA. This noninvasive trans-dermal and circulatory health technology is just the first product to be offered. Circularity is invested in revolutionizing the healthcare space. They plan to do this by creating cutting edge medical products and procedures that are both patient and physician friendly while being effective in minimizing and eradicating diseases.

What "Behind The Scenes with Host Laurence Fishburne" Will Bring to the Table

Behind The Scenes has been an innovator in bringing information to the forefront in the public television space. The award-winning series features segments on the newest technologies, as well as fresh takes on existing entities, phenomenon, and natural occurrences. The show's website boasts that the television series "highlights the evolution of education, medicine, science, technology and industry through inspiring stories."

Aside from the Emmy-winning and Academy Award nominated actor Lawrence Fishburne as host, the program has an award-winning creative development team. Viewers walk away with a rich knowledge of the subject. Viewers may have known about this subject their whole lives, or it may be about something completely new. Viewers learn an evolving aspect of the topic which keeps the perspective fresh.

The dawning of a new age has appeared with this collaboration. Individuals who want to know more about what the health science field is bringing into our hospitals and doctors' offices will not be disappointed. In today's world, it is imperative that we are advocates for our own health.

Coming Soon: Miami ReLife's Dr. Steven Gelbard

The first series is with Dr. Steven Gelbard, a nationally-famed authority with his ReLife Miami Institute on stem cells. Dr. Gelbard presents D'OXYVA's Nobel Prize-winning science as a regenerative medicine. Dr. Gelbard is involving his direct contacts with top NFL players and other top sports celebrities in the monthly series, along with 2540 top neurosurgeons and other experts working under ReLife.

Consumers might imagine having the ability to receive D'OXYVA and other innovative treatments and non-invasive procedures for chronic wound care amid the luxury of a five-star hotel. Behind The Scenes guest, Dr. Gelbard, a Tufts School of Medicine educated neurosurgeon, makes it happen right now. Medicine has left the hospital building and has become the proactive choice of the health conscious. Viewers can all look forward to learning more about how to live a healthier and more informed lifestyle from this awe-inspiring episode.

According to Norbert Kiss, President and CEO of Circularity Healthcare, this collaboration is door busting. Mr. Kiss tells us, "[We] can offer unprecedented access to this amazing Emmy-winning show called Behind the Scenes with very competitive terms due to our strategic involvement. We welcome any expert."

Don't miss the evolution. It's being televised. Circularity and Behind The Scenes viewers can stay tuned for a mind-fortifying experience!

Circularity Values:

Circularity believes in a long-sought-after goal in health care; people should have access to one health application that solves most of their short and long term health issues without compromising other aspects of their health while doing this quickly, affordably, and without pain.

Circularity develops, manufactures and markets advanced technologies that significantly improve quality of life by improving some of the most essential physiological functions in the body.

About Behind The Scenes With Laurence Fishburne

Behind The Scenes is an award-winning program that highlights new stories and innovative concepts through groundbreaking short-form and long-form documentary presentation. The program, which is anchored by a veteran production team with decades of industry experience, is able to effectively communicate the most critical stories to a wide and diverse audience.

Behind The Scenes with Laurence Fishburne, has established an impressive and heralded career, amassing over one-hundred credits across the varied platforms of stage, television and film. He's well known for major for roles in such films as; John Wick 2, Fantastic 4 Rise of the Silver Surfer, Mission Impossible III, Mystic River, Boyz n the Hood, What's Love Got to Do With It, and Apocalypse Now. On the small screen, the award-winning and versatile actor played compelling roles in shows such as CSI: Crime Scene Investigation, CSI: Miami, CSI: New York and Hannibal. The Behind The Scenes Actor currently stars as Pops on the hit TV comedy Black-ish.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D'OXYVA. One of the main mechanisms underlying D'OXYVA's science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com, or doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care by phone toll free at 1-855-5DOXYVA or at 1-626-240-0956.

Forward-Looking Information

This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management's expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

For the original version on PRWeb visit: https://www.prweb.com/releases/innovative_collaboration_the_cutting_edge_of_medicine_goes_behind_the_scenes/prweb16783651.htm

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Innovative Collaboration: The Cutting Edge of Medicine Goes - Benzinga

Following in the very successful footsteps of its sister companies GE Additive, GE Aerospace, and GE Oil and Gas, now GE Healthcare is starting to seriously look at 3D printing. After signing with Formlabs to streamline 3D printing of anatomical models, the giant is now partnering with Advanced Solutions Life Sciences (ASLS) toadvance the field of 3D biofabrication.

And if GE Healthcare is moving fast, bioprinting is not going any slower. It may be the positive momentum from the latest Termis (the leading regenerative medicine event) in Orlando, or maybe 3dpbm is just in the right place at the right time, but 3D Bioprinting Solutions has also been making some giant leaps recently. Now Advanced Solutions Life Sciences, the company founded by Michal Golway, one of the first pioneers in bioprinting, is going to benefit from GEs powerful distribution and R&D means.

As per the agreement, GE Healthcare will distribute the worlds first integrated 3D bioprinter + confocal scanner (BioAssemblyBot + GE IN Cell Analyzer 6500HS) as part of a strategic R&D and distribution partnership that sets out to personalize tissue regeneration. The integration of IN Cell Analyzer and BioAssemblyBot systems technologies will embed cellular-level assessments into the 3D bioprinting workflow used to create human tissue models.

Bioprinted tissues are small in size and die quickly, due to an inability to engineer small blood vessels the bodys supply network. ASLS patented Angiomics technology enables bioprinted microvessels to self-assemble into functional capillary beds, which deliver nutrients, oxygen, and hormones to the 3D tissue model and remove waste. This partnership would allow life scientists and tissue engineers to quickly design, build and image living, vascularized 3D tissues in a single, agile process.

Printing multi-material 3D objects inside of microwell plates allows scientists to efficiently move away from traditional 2D monocultures on plastic, to 3D discovery and cytotoxicity models that more accurately reflect native biology and disease, said Emmanuel Abate, General Manager of Genomics & Cellular Research, GE Healthcare Life Sciences. By combining this flexibility and precision of the BioAssemblyBot with the image quality and speed of the IN Cell Analyzer 6500 HS confocal screening platform, the prospect of automating high content screening in 3D models can become a reality.

Currently, biopharmaceutical companies test their drugs in 2D models and animal models. Precise 3D models provide a more physiologically relevant environment for drug testing because they mimic human reactions. The power of both of these platforms brings a new level of efficiency, speed and quality with assay designs and 3D biofabrication, said Michael Golway, President & CEO of ASLS.

Traditional 3D bioprinters are not designed for quality or interoperability with the high-throughput screening methods that pharmaceutical developers use to identify drug candidates. This alliance will result in a new product to address this challenge: an integration of GE Healthcare Life Sciences IN Cell Analyzer confocal imaging platform with IN Carta cell analysis software, and ASLS BioAssemblyBot 3D bioprinter with TSIM design software.

For pharmaceutical companies, where the average time to develop a new drug candidate may take over seven years, moving from traditional stage-gate testing processes to a lean, agile workcell for 3D tissue fabrication and assessments will shorten development timelines. The integration between IN Cell Analyzer and BioAssemblyBot enables the automated inclusion of cellular imaging information into the tissue modeling process so that new therapies can be scaled more quickly and effectively.

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GE Healthcare pairs up with Advanced Solutions on regenerative tissue manufacturing - 3DPMN

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Creating an object from a scratch: not just an illusion, but a reality. Nowadays, there is a way to turn your ideas into three-dimensional objects and here, the magic word is 3D printing.

This technique, also called additive manufacturing, consistsofn successive layer-by-layer depositions of material which, all together, form the desired object. Contrary to conventional techniques, 3D printing allows the manufacturing of complex shapes using a small amount of material and reduced number of fabrication steps.

With the term 3D printing, we usually refer to technologies which use polymers, resins and molten metals as printing material to produce three-dimensional objects. However, over the last 30 years, this concept has developed toward new horizons, leading to the production of 3D artificial bio tissues which resemble the architecture and function of native ones. In this case, when used to deposit living cells layer-by-layer, we talk more specifically about 3D bioprinting.

Nowadays, the most common technologies for 3D bioprinting are based on approaches such as extrusion printing, stereolithography, laser-based methods, and melt electrowriting. These technologies have the ability to accurately control the spatial orchestration of multiple cell types and biomaterials in an automated patterning process. However, they also present some disadvantages, e.g., the difficulties in reproducing convoluted geometries, which in fact are typical of native tissues. Moreover, a severe restriction is represented by long printing times when large, physiological-sized constructs need to be fabricated. This characteristic also affects the large-scale production of artificial tissues, thus limiting the adoption of 3D bioprinting at an industrial level.

In order to overcome these limitations, Prof. Riccardo Levato of the University Medical Center Utrecht, the Netherlands, and Prof. Christophe Moser of cole Polytechnique Fdral Lausanne (EPFL), Switzerland, have proposed a new strategy for the 3D bioprinting. In their recently published article they present a Volumetric Bioprinting (VBP) approach to create any convoluted free-form geometry with unprecedented speed of fabrication.

This method takes inspiration from the principle of computed tomographycommonly used in medical imagingalthough in reverse. In VBP, a cell-friendly visible laser light is used to cast multiple tomographic projections onto a light-sensitive hydrogel embedding stem cells.Although the whole volume is photo-exposed, the composition of these projections creates a 3D light field that provides enough energy to crosslink the hydrogel only in correspondence to the desired design. This results in a 3D construct, floating in the host hydrogel, which can be realized in the time frame of a few tens of seconds.

Contrary to other bioprinting technologies, e.g., stereolithography, which works in the time scale of hours to produce clinically-relevant sized (> cm3) structures, VBP thus permits the fabrication of living tissue constructs with analogous dimensions and complex 3D architectures by strongly reducing the fabrication times. As a consequence, VBP not only leads to high mimicry of the architecture of human tissues, but it preserves cells by minimizing the time outside of their optimal culture environment.

Given the freedom to print any complex geometry, anatomical, patient-specific grafts with unprecedented precision and short fabrications times, VBP lends itself to be the new paradigm of regenerative medicine, also paving the way for the scaling-up of tissue production. Thanks to these characteristics, Prof. Levato and Prof. Moser expect this approach will find application in many fields also outside tissue engineering, even including soft robotics. As they claimed, We expect Volumetric Bioprinting technology to be part of the bioprinting toolkit that will one day create fully functional organs.

In the future, the authors aim to further improve VBP technology by addressing the structural function of load bearing tissues, developing new materials and fully matching the function between their biofabricated tissues and the native ones. This sounds promising to us: we are looking forward to seeing new developments!

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Volumetric Bioprinting: The New Paradigm in Regenerative Medicine - Advanced Science News

AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine have announced a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent pending combined reprogramming and gene editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity and government grants, in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Mike Perry, PhD, chief executive officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliative - focused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dennis Roop, PhD. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs and improve patient outcomes, said Ganna Bilousova, PhD, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, PhD, the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the CU Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

Photo at top: From left, Igor Kogut, PhD, Ganna Bilousova, PhD, and Dennis Roop, PhD.

Guest contributor: Gates Center for Regenerative Medicine/ASX

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AVITA Medical Teams With Gates Center to Advance Therapeutic Skin Restoration - CU Anschutz Today

No longer just for professional athletes, these are the stem cell and regenerative medicine options DCs need to know about

The health care landscape continues to evolve at a dizzying pace. Insurance deductibles are increasing, and this has placed a financial burden on patients who are required to self-pay for necessary and yet uncovered services.

The opioid crisis has left physicians with limited clinical options to treat chronic pain and dysfunction. At the same time, pressure has been placed on health care providers to provide affordable alternatives to invasive procedures that provide limited clinical options with high failure rates. This confluence of supply and demand has resulted in the growth of emerging therapies in the field of stem cell and regenerative medicine. These therapies are bringing hope to patients and new opportunities to health care providers who deliver them.

Regenerative medicine is the process of replacing or regenerating cells and tissues to restore normal function. Initially popularized by professional athletes, these therapies have become mainstream. More than 27 million Americans suffer from osteoarthritis today, and in 2030 25% of U.S. adults will be diagnosed with osteoarthritis. The global regenerative medicine market is predicted to reach more than $100 billion by 2022.

These moderately-invasive regenerative procedures are eclipsing traditional highly-invasive procedures, such as hip and knee implantation, which will have a global market of $35 million over the same period.

There are four primary regenerative medicine options:

Irritant therapies include prolotherapy, ozone and prolozone. Theyincludeadding multipleirritatingsubstances along with numbing agents into degenerated or injured joints, and areas of pain.

These therapies cause inflammation to kick-start regeneration by stimulating the body to send in macrophages, which are cells that ingest and destroy theirritantsolution and trigger the healing response. Irritant therapies are an excellenttreatmentfor all forms of musculoskeletal and joint pain includingchronic neck and back pain, and rotator cuff injuries.

The effect of irritant therapies is analogous to jump-starting the battery in a tractor to get the engine to turn over.

Protease inhibition therapy eliminates the factors causing cartilage degradation, tissue breakdown, inflammation and pain. It cleans and protects joints. It is most commonly used for patients with osteoarthritis (OA) and degenerative disc disease (DDD).

It includes therapies such as alpha-2-macroglobulin (A2M) and interleukin-1 receptor antagonist protein (IRAP). A2M and IRAP are proteins found naturally in our blood. They act as protease inhibitors by binding to and inactivating damaging proteases in the body. Proteases are catabolic enzymes that break larger molecules into smaller units. Proteases trapped in the joints catabolize cartilage and break it down, causing arthritis. A2M is a large protein made in the liver. It blocks activity for all known molecules that cause cartilage breakdown. It works like a Venus flytrap by having a bait-and-trap mechanism on two sides.

Once the proteases are bound on both sides, the molecule initiates a suicide cascade and dies, allowing it to be flushed out of the area by the body.

The binding effect of protease inhibition therapy is analogous to de-weeding a garden and tilling the soil before planting.

A fibronectin-aggrecan complex test (FACT) may be used to determine the presence of FAC, which is a biomarker or indicator of cartilage breakdown caused by proteases. FAC is a unique molecular complex that is specific for painful inflammation of the spine and cartilage.

A small sample of fluid is taken from the joint or disc and sent to a lab for testing. The test looks for the presence of FAC in the fluid sample and determines where you are: FAC+ or FAC-. FAC+ patients are identified as ideal candidates for A2M injections and have a 90% rate of responding to the A2M therapy.

Stem cell therapy is focused on concentrating the workhorses of regeneration and restoration of tissues: stem cells. This results in greater cell signaling and cell recruitment than other regenerative therapies. Stem cells are known as mesenchymal signaling cells. They are considered pluripotent, which means they are undifferentiated and can replicate into various cell and tissue types.

Stem cells are found in bone marrow, the soft spongy tissue found at the center of large bones. Introducing stem cells into an injured area initiates the healing response, repairing damaged tissue by growing new, healthy tissue. The most common stem cell therapies include bone marrow aspirate concentrate (BMA), nanofat and stromal vascular fraction.

Injecting stem cells into an injured area is analogous to planting seeds in a garden.

Growth factor therapies are focused on cell signaling and cell recruitment. Blood is made up of white blood cells, red blood cells, and platelets that are suspended in plasma. Platelets are most widely known for their ability to clot blood. Platelets are also highly rich in growth factors that are proteins that stimulate healing. When an injury occurs, platelets become activated, migrate to the site of injury and release growth factors.

Growth factor therapies are the most popular provider choice for the low-cost regeneration of tissues and include platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM). The therapy includes drawing the patients blood followed by centrifugation to concentrate the platelets and exclude other unwanted blood products.

Another type of growth factor therapy is amniotic fluid growth factor (GF) injection therapy. Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. Human amniotic fluid is sourced from consenting mothers during full-term C-sections. It contains over 200 growth factors, cytokines and proteins. The therapeutic use of amniotic fluid is regulated by the FDA. It must be tested for disease and may not include any viable cells. Amniotic fluid GF therapy has both anti-inflammatory and anti-microbial properties and includes naturally-occurring hyaluronic acid for lubrication. It is most commonly used to promote the repair and reconstruction of soft tissues including cartilage and tendons.

Exosomes are being heralded as the next frontier of growth factor therapies. While they are not cells, exosomes play a vital role in the communication and rejuvenation of all the cells in the body. Exosomes are extracellular vesicles, or small bubbles, released from cells, especially from stem cells. These culture-expanded cell secretions are derived from human placental tissue. They allow for cell-to-cell communication, transporting molecules that are important regulators of intracellular information. Exosomes act as a food source for stem cells and prolong their activity. Exosomes are anti-inflammatory and include more than 300 growth factors, cytokines and proteins.

Patients with Lyme disease, burns, chronic inflammation, autoimmune disease and other chronic degenerative diseases may benefit from including exosomes in their treatment regimen. The application of growth factor therapies is analogous to applying fertilizer to a garden to help the crop grow and flourish.

Moving stem cell and regenerative medicine forward in the treatment algorithm may eliminate the need for other ineffective or potentially harmful therapies. These therapies provide new hope for patients whose only alternatives have been long-term medication, steroid injections, and costly and time-consuming surgery and rehab.

Stem cell and regenerative medicine therapies may only be provided by licensed medical professionals following all appropriate rules and regulations. An understanding of these emerging therapies and the benefits they may provide is essential as the collaboration between doctors of medicine and chiropractic increases and we join forces to combat chronic pain, dysfunction and disease.

MARK SANNA, DC, ACRB LEVEL II, FICC, is a member of the Chiropractic Summit and a board member of the Foundation for Chiropractic Progress. He is the president and CEO of BreakthroughCoaching, and can be reached at mybreakthrough.com or800-723-8423.

Originally posted here:
A primer: stem cell and regenerative medicine as 'the' emerging therapy - Chiropractic Economics

SAN CARLOS, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc., (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company plans to present at the following conferences in December:

Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at http://ir.iovance.com.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patients own immune cells to attack cancer. TIL cells are extracted from a patients own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the companys TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovances T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit http://www.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our). We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the U.S. and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to successfully submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates that have been granted breakthrough therapy designation (BTD) or regenerative medicine advanced therapy designation (RMAT) by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Companys product pipeline; the successful implementation of the Companys research and development programs and collaborations; the Companys ability to obtain tax incentives and credits; the guidance provided for the Companys future cash, cash equivalent, and short term investment positions; the success of the Companys manufacturing, license or development agreements; the acceptance by the market of the Companys product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Companys control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Companys business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyses of these trials or subgroups within these trials; a slower rate of enrollment may impact the Companys clinical trial timelines; enrollment may need to be adjusted for the Companys trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in the Companys cervical cancer trial may have an adverse effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient populations may result in changes in preliminary clinical results; the Companys ability or inability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical, safety, manufacturing and control requirements; the Companys interpretation of communications with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Companys ability to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development process or review of the Companys product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own facility may adversely affect the Companys potential commercial launch; and additional expenses may decrease our estimated cash balances and increase our estimated capital requirements. A further list and description of the Companys risks, uncertainties and other factors can be found in the Companys most recent Annual Report on Form 10-K and the Companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or http://www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investor Relations Contacts:Annie ChangSolebury Trout646-378-2972achang@troutgroup.com

Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com

Media Relations Contact: Rich AllanSolebury Trout646-378-2958rallan@troutgroup.com

Excerpt from:
Iovance Biotherapeutics to Present at Upcoming Investor Conferences in December - BioSpace

I recently had an experience that highlights, for me, some of what is wrong with our medical insurance system.

I love playing tennis, but my knees have been deteriorating. The cushioning material is wearing away, and there is arthritis. The increasing pain and swelling I was experiencing led me to consider knee replacement surgery, or the end of my tennis career. Neither choice was appealing.

My naturopathic doctor suggested I consider PRP therapy. Platelet-rich plasma treatment has been growing in popularity because it often provides an alternative to knee- and hip-replacement surgery. It can also help tennis tendinitis and rotator cuff injuries. Professional athletes, including Tiger Woods, use PRP therapy. Despite its successful track record, it is not covered by insurance, Medicare or otherwise.

PRP therapy involves removing a small amount of ones blood and separating out its components in a centrifuge. The concentrate is then injected into the area that needs help. The platelet-rich blood attracts stem cells, the bodys repairmen, to the area to rebuild tissue, muscles and tendons.

I love this concept because it uses the bodys own healing ability to rebuild worn-out parts. As a lifelong proponent of homeopathy and other natural healing modalities, I decided to give PRP a try. On Sept. 10, I drove to the office of Dr. John Herzog in Falmouth, Maine, to check it out, despite the fact that Medicare would not cover the cost.

Dr. Herzog is an osteopathic orthopedic surgeon who has performed thousands of surgeries to replace knees and hips over his 30-year career. In 2009 he decided to stop doing surgery and focus on PRP, after finding how much it helped his own knee condition. He has treated more than 3,000 patients since then, with an 80% success rate.

After a basic physical exam to see how well my knees flexed, we looked at them with ultrasound. It was fascinating to watch as Dr. Herzog explained the state of each knee cavity. Fortunately, I was not in a complete bone-on-bone condition; both knees were good candidates for PRP treatment.

I initially thought I would test the treatment on one knee, but opted to have both done. The cost was $600 for one knee, $1,000 for both. Despite paying for this out-of-pocket, it seemed a reasonable cost given the much more expensive alternatives. Knee and hip replacements average $30,000.

Dr. Herzog drew a cup of blood from my arm, put it in a centrifuge and injected the platelet-rich concentrate into both knees. I was out of the office on my way home in a little over an hour. I was told results were normally felt within 4 to 6 weeks, and could last up to a year or more. Every person responds differently, some return for tune-ups after a year.

The following day both knees were quite sore and swollen as blood and oxygen rushed to the area. The next day the swelling began to subside, and five days after the treatment I played tennis. Now, some two months later, the results have been remarkable. Both knees are stronger. Recovery after tennis is greatly reduced. I stopped wearing knee braces, and my movement on the court is now the best its been in years. Im considering playing three times a week instead of two. I feel a little bit like Forrest Gump!

Given the significant success rate of this treatment, the low cost, low risk and absence of side effects, why is it not covered by medical insurance? When I posed this question to a spokesperson at Concord Orthopedics, where one doctor now offers the treatment, their guess was the lack of clinical data on PRP therapy. Its clear this therapy is rapidly gaining in popularity because it is effective and inexpensive.

Dartmouth-Hitchcock offers PRP treatments. Vermont Regenerative Medicine, located in Burlington, recently ran a series of full-page ads in the Monitor advertising their services.

You would think insurance companies and the medical establishment would jump on embracing such benign treatment. I was able to afford the $1,000 fee to have both knees treated, but how about all the people who cannot?

For many years, acupuncture and chiropractic care were not covered by medical insurance. Now they are. Similar to PRP therapy, they are effective, non-invasive and low cost. All therapies that employ our bodys healing ability to recover from injury should be put at the top of the list of treatments covered by insurance. Especially when they offer a true alternative option to more expensive and invasive surgery.

(Sol Solomon lives in Sutton.)

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My Turn: The malaise of medical care - Concord Monitor

Ever since we began covering them as the first Russian bioprinting company,3D Bioprinting Solutions, or 3dbio for short, came across as more focused on raising awareness on bioprinting by conducting high profile experiments than on exploring commercial applications for the future of bioprinting. Visiting the companys lab in Moscow, and speaking with Co-founder Yusef Khesuani, we learned that it may be exactly the opposite: maybe we are not talking about 3dbio nearly as much as we should.

In fact, that may all be changing now with some more announcements coming up in the next few weeks. One of the main issues limiting 3dbios visibility in Western Europe and North America may be related to the fact that they are based in Russia. Due to generalized lack of awareness of Russian matters in the West, the way for 3dbio to get some well-deserved recognition has been to do things that are quite literally out of this world: building Russias first bioprinter (Fabion) in 2014, bioprinting and implanting a rodent thyroid gland in 2015, developing a bioprinter based on magnetic levitation and finally sending (not once but twice) said bioprinter, aptly named Organ.aut, to print in space on the ISS. That was in 2018.

Now the time has come for the bioprinting company to come back down to Earth and leverage its space-faring experience to venture into more short-term commercially viable businesses, such as bioprinting meat or in-situ bioprinting of tissue grafts. We spoke about these and the bioprinting markets status in general with Dr. Khesuani.

3D Bioprinting Solutions was founded by INVITRO, the largest private medical company in Russia, which is why the laboratory is located on one floor of the INVITRO facility in Moscow. The companys other Co-founders include INVITRO founder Alexander Ostrovsky and VIVAX BIO CEO & CFO (also INVITRO Advisory Committee Member) Yakov Balakhovsky. New York-based VIVAX BIO is actually 3D Bioprinting Solutions mother company through a complex structure that sees 3dbio as the core research lab used to fuel ideas for new, bioprinting based, commercial startups.

We hope that our R&D efforts will serve to create new spinoffs that will work as business startups, Dr. Khesuani begins. 3dbio is not a classical startup. We are here to set the foundations for science and give direction. Now we are going to launch a new startup next January, focusing on bioprinting artificial (bioficial) meat and based on the successful experiment we conducted printing meat on the ISS, together with Aleph Farms. In this case, we used the muscle cell sources supplied by Aleph Farms and combined them with our bioprinting technologies.

While artificial (or bioficial) meat may be closer to commercialization, the ultimate goal of 3dbio has been to produce human organs from the very beginning. Khesuani points out how bioprinters today are made primarily to print scientific papers rather than organs or implantable tissues. They basically combine different cells, different hydrogels and different geometries. Every different combination of one of these three factors is a basis for a new scientific paper, he says. Bioprinters are also used for drug discovery by companies like Organovo, another firm that started with the goal to print organs then moved to drug research. Khesuani believes that the drug discovery analysis process for bioprinted tissues is still too incomplete to attract big pharma companies.

One key difference between 3dbio and other bioprinting companies is that, after the Fabion and Fabion 2 systems, which are based on different types of extrusion, deposition and curing processes, they have now been working on a morevolumetric approach for bioprinting in spaces microgravity environment. While extrusion and deposition systems are considered ideal for flat, layered organs, such as cartilage and skin, more complex, tubular organs, such as, for example, a urethra, need a more tridimensional approach.

Using the Organ.aut magnetic system and further developing new acoustic means of controlling cellular materials in microgravity, 3dbios volumetric technique is able to produce more complex constructs without requiring a scaffold. The bioprinter now on the ISS uses magnetic fields to control the cellular materials. Using microgravity as a co-factor, it implements a scaffold-free, nozzle-free and label-free (no magnetic nanoparticles involved) formative approach. 3dbio researchers also showed off an early version of the acoustic system (in the video above). In theory, one could be used to distribute the material on the X and Y axes while the other could be used to control them along the Z-axis.

What feels particularly amazing is that, while visiting the 3dbio lab and speaking with Dr. Khesuani, Earths orbit, all of a sudden, seems a lot closer. Supplies from 3dbio regularly go up to (and down from) the ISS, in special containers that even have a stamp showing they transited on the ISS (seen in the photo above). In general, all of Moscow seems to have a particularly close relationship with space. When 3dbio approached Roscosmos about bioprinting in space in 2014 their proposal was met with enthusiasm. The project was conducted very rapidly, in spite of the first launch failing. Now laughing about it, Khesuani revealed that the bioprinter that fell back to Earth from a height of about 80,000 meters was actually still functional and will be exhibited at the Space Museum in Moscow in March.

Another approach to bioprinting that 3dbio is exploring is that of using a multi-axis robot for in-situ contour 3D bioprinting also considered a type of volumetric 3D printing. We have also been working with Kuka on using one of their robots to 3D printing tissue grafts directly on the body and we are soon going to announce another startup focusing on this technique, Khesuani reveals. We implemented our nozzles on the robotic arm to print directly on skin defects. One key issue that we are approaching is that our system will be able to use computer vision and machine learning algorithms in order to compensate for a living organisms body movements while breathing.

Along with the software, 3dbio developed a number of innovations for material handling in order to make the skin graft truly effective These will be officially presented next December 6th, in a joint release with Kuka. The first experiments will be conducted on small size pigs. Some experiments were already successfully conducted on rats, however, Khesuani explained that there is a significant gap between experimenting on small and large animals and an even bigger gap between large animals and humans. We expect to have the results of the tests for in-situ bioprinting on the pigs sometime next year, he said.

If bioprinting may still take years to bring real commercial applications, is bioprinted meat any closer? The answer lies in what we mean by meat. Just like industrial applications, to fully leverage the benefits of digital, additive manufacturing we need to completely reinvent food products. Thats one of the reasons why there is so much interest for bioprinting in space, where astronauts and cosmonauts already need to eat very different paste-like food products.

A lot of people think the goal is to bioprint a steak, Khesuani explains. If that is the final objective, then regenerative medicine may actually be closer. What we need to do is imagine new food products based on cellular agriculture. Even snacks such as Mars or Snickers were invented for military purposes in the 50s and 60s. We need to think of food products that do not exist today.

One of the biggest limits, in food as in medical bioprinting, is the lack of adequate cellular materials. Its almost like having Google without having the Internet, Khesuani says. We have the bioprinters to surf but we lack the materials to surf on. For in-situ medical applications, 3dbio developed the Viscoll line of collagen materials, which are suitable for any 3D bioprinter. It is aconcentrated sterile solution of highly purified Type 1 collagen which can be used to print three-dimensional scaffolds directly, or blended with cell suspensions to print cell-laden hydrogels. It was designed for the engineering of biocompatible and non-toxic, three-dimensional tissue constructs ideal for tissue engineering and regenerative medicine. A unique feature of the Viscoll hydrogel range is the use of a viscous solution of collagen with a physiological pH value, enabling the addition of living cells or spheroids without neutralization prior to 3D bioprinting. This significantly reduces the time and effort spent on conducting experiments and increases the viability of biological material.

The wide range of collagen concentration allows researches to produce designs with different mechanical densities and rates of bioresorption, depending on their biomedical purpose and the type of cells being used fibroblasts, multipotent mesenchymal stromal cells, pancreatic islet cells, and so on. The presence of any collagen Types I-V or other ECM proteins (Vitronectin, Fibronectin, Laminin) in the hydrogel determines the specific tissue type of the constructs: skin, bone or cartilage tissue, blood vessels, and parenchyma of internal organs.

Selling bioprinters is also a possible commercial business, and several FABION systems are now installed worldwide. Khesuani does not expect this to ever become a core business for 3dbio as operating these machines require engineering experience that is not often found in a scientific laboratory. The systems are generally installed in institutes that partner directly with 3dbio on developing new applications.

We have to be optimistic Khesuani says -. When we started there were maybe six bioprinting companies all over the world, now there are over 80 including companies, like CELLINK that have a great business model, although different from ours. Our goal was always to print human organs. We need to focus on that, rather than on selling more machines. He believes that other possible areas of expansion could be the development of medical devices and a new B2S business to science segment, where 3dbio could provide scientific results from experiments and help to commercialize them, as they are doing with the bioprinter in space.

One such result, also achieved in space, was growing of protein crystals, another was the development of new materials in space to use in regenerative medicine. Yet another was the production of 3D structures using bacteria, also in space, to study antibiotic resistance. 3dbio continuous to build networks with some of the most prestigious universities in the world and is entering talks with other space agencies such as ESA and JAXA. Next up will be the next generation of magnetic and acoustic bioprinters for volumetric bioassembly, as 3dbio continues to go where no other bioprinting company has ever gone before while building the bioprinting application market here on Earth.

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The future of bioprinting is out of this world at 3D Bioprinting Solutions in Moscow - 3DPMN

Hitachi, Ltd. headquartered in Tokyo, Japan, is focusing on Social Innovation Business combining its operational technology, information technology and products, has developed a new automation technology of 3D culture, solving problems of the previous 3D culture using Hitachi's Automated Cell Culture Equipment for iPS cells.

Automation of both 2D culture and 3D culture using this equipment makes it possible to automatic massive manufacture a variety of cell types such as cardiomyocytes, meeting customer needs. The automation technology was developed by collaborative research with Myoridge Co. Ltd. which has culture technology of iPS cell-derived cardiomyocytes by the protein-free method.

Furthermore the support service to establish an automatic manufacturing process for customers who are considering automation of manufacturing regenerative medicine products will be started on December 1st, 2019. As for the service, Hitachi will examine customers' manual manufacturing process to find out the important parameters, and suggest how to optimize them by the development knowledge of automation technology of 3D culture.

Expanding the market of regenerative medicine to recover the functions of tissues and organs is expected in recent years. A large number of cells are required for regenerative medicine but it is difficult to manufacture an enough amount of cells manually. So the automation technology of mass cell culture is necessary to expand the market of regenerative medicine.

Hitachi had been developing automation technology of mass iPS cell culture, and developed the automated cell culture equipment for iPS cells for research use in June 2017. Adopting the closed flow channel for the connection of the culture vessels and the medium bottles, the equipment is capable of cell seeding, culturing, and monitoring in sterile environment and offers stable supply of high-quality mass cells. Hitachi commercialized the automated cell mass culture equipment which has the necessary functions to comply with the Japanese regulation, GCTP for the first time in Japan in March 2019.

Hitachi automated the new 3D culture (low medium cost, low shear stress, and simple medium change process) by collaborating with Myoridge, solving problems of the previous 3D culture. The previous 3D culture has problems such as using a large amount of medium because of the height of the culture reactor, the shear stress to cells from the agitating medium, and the complex process of medium change. Hitachi started the collaborative research with Myoridge in October 2018 and developed the automation technology of the new 3D culture by distributing spheroids both uniformly and densely on the cell culture vessel for 2D culture. Furthermore, Hitachi manufactured cardiomyocytes by the automation technology more effectively than by manual. The technology is probably able to be applied to a variety of cell types and make them be manufactured automatically.

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Hitachi develops automation technology of 3D culture - BSA bureau

The future of innovation in the field of medical devices and regenerative medicine depends on the deep understanding of the mechanisms of interaction between biomaterials and the host biological environment. New chemistry and material engineering will need to emerge to produce biocompatible, bioactive, and bioresponsive biomaterials. The European Society for Biomaterials (ESB) offers a multidisciplinary environment where scientific knowledge is promoted, and technological solutions can be found. Speaking to ESB President Pamela Habibovic, we found out about some of the latest developments in advanced medical devices, regenerative medicine, and Biomaterials research and development.

The ESB is the oldest and one of the largest societies in the field of biomaterials. We bring together scientists in this field, in order to really stay up to date with the developments in the field. We connect with our affiliated societies in Europe and we do the same with our international sister societies. For example, every year, the presidents from each affiliated European society come together to discuss what is happening on the national level in the individual countries and how we can learn from each other and strengthen these developments.

In addition to this, we are also playing the liaison between our members and our sister societies (such as those in the US, Canada and Asia). We are trying to understand the developments in the other parts of the world in this field and communicate that to our members. Moreover, we liaise with the European Commission to both understand the European vision and priorities in research and development funding, and to inform the policy makers about developments in our field. In short, we explain how biomaterials can be used to address the societal and economical challenges we are facing.

We also try and stimulate them to open possibilities for collaboration with biomaterials societies in China or in the US for example, where sometimes research is accelerating very quickly, and so we want to stay up to speed with the societies in these countries. The ESB also has a lot of attention for the younger researchers in the field. We offer them possibilities to stay informed and educated on relevant topics such as scientific writing, grant applications, and job opportunities. An important player in these activities is the ESBs Young Scientists Forum. The ESB has a lot of really different roles; it is bringing everybody together in the biomaterial field, academic researchers, clinicians and people from the industry, and offering them a platform to exchange ideas and knowledge.

The whole biomaterials field has changed over the past couple of years and it is still changing. Before, we had the materials that were passively taking over the function of a malfunctioning organ or tissue, mainly medical devices such as hip implants and mechanical heart valves etc, and whilst these are still tremendously important and have made a difference to many patients, we are now expecting more and more from biomaterials.

We dont want them to just sit there and to perform their mechanical function. We really want them to actively interact with the body, and to instruct the body to exert a certain function. For example, to trigger the process of regeneration, or to stop infection or inflammation.

We are trying to develop materials that have an advanced interaction with the environment of the body. We also see that theres a greater need for models that are more physiologically representative than conventional systems based on cell and tissue culture in 2D. This will reduce the number of animal studies needed to test new drugs, regenerative therapies, etc. I think biomaterials are already playing a very important role in the context of creating a physiologically relevant microenvironment.

It is important to have models where we can understand diseases and develop treatments. However, current developments of new medical devices, implants and tissue engineered constructs will remain equally important.

I think the biggest challenge is the translation of research itself. We expect researchers to have all the knowledge ranging from the doing fundamental research, to doing everything that is needed to turn such an innovation into a product. Nowadays, if I look at academia, we expect researchers to actually take the initiative to translate their research findings into something that is potentially clinically or commercially relevant. However, many of us academics, we do not have the important knowledge to do that. Many researchers simply do not have the time or skills to turn our research into business plans.

What I think is one of the biggest challenges is finding a liaison between research and people who are experts in making the research translate into something clinically applicable, or even a commercial product. This includes actively helping the scientists identify the potential ideas that can then be translated into clinical applications and helping them through the process of regulation and business plan development. I think that this is missing and that many scientists are struggling with this. Many of us working in this field do have the final aim of helping a patient, but it is difficult to go from a finding in the lab to something that is commercially viable; there is still insufficient support in this process in my opinion.

What I consider important in this context is the fact that the field of biomaterials is insufficiently making use of many available technologies from other fields. For example, in terms of wearables for sports and/or monitoring our health, eventually this will start playing a more important role in medical devices and regenerative medicine as well. In order to do that, we really have to learn from other fields and integrate innovations from those fields into ours.

We have to make much more use of the fields of micro- and nanotechnology but also data science, for example. There is a lot of advanced engineering going on in other fields, but these havent yet reached our field. I think that what would be great is that if the ESB could play this role and actually monitor developments in other fields and try to bring these to our scientists and vice versa. I hope we will be able to play a more proactive role in this context in the future.

The ultimate aim of our field is to make patients quality of life better. Im hoping that in five years from now, we will have even more therapies in which biomaterials play a role, which have reached the clinic and have actually helped patients. I also believe that without a very high end fundamental research, the innovation will stop so Im also hoping that the field will continue to innovate (for example, by using tools from other fields), but there is also so much more unexplored in our field.

Im hoping that in five years from now, there will be significant progress both in the translational side of the field as well as an fundamental side and that there will be enough funding for both because we really do need both to continue to innovate.

In terms of where the ESB will be in five years from now, I think we will still be there. We will be able to even more actively monitor, influence and support the developments in the field. I find monitoring what is happening in the world, and really making sure that we stay at the highest possible level as compared to the rest of the world imperative, and in addition to that, providing support to our scientists (especially our young scientists) in these development. That is really something that I hope we will be able to achieve and in five years from now be larger and more active than ever.

Pamela Habibovic PresidentEuropean Society for Biomaterials president@esbiomaterials.euTweet @ESBPresidenthttp://www.esbiomaterials.eu/

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Biomaterials research and development: Welcome to the ESB - SciTech Europa

Join us! To furnish your research and ideas and to examine your interpretation at International Conference on Stem Cells and Regenerative Medicine which is scheduled on November 06 - 07, 2019 at Tokyo, Japan.

Stem Cells 2019 provides you with a unique platform to share your generous thoughts and ideas related to your research and it adds a valuable acknowledgment to your profile.

The conference is based on the theme of Novel Techniques in Stem Cells and Regenerative Medicine. Based on this, we are delighted to have your presence at our conference.

Highlights include: Stem Cells, Regenerative Medicine, Tissue Regeneration, Therapeutic Cloning, and Stem Cell Transplantation which is detailed in Stem cells

To Visit our conference webpage: http://stemcells.pulsusconference.com/

Hope you will join hands with us to encourage Stem Cells research to have a better tomorrow.

We look forward to receiving a favorable consideration from you.

Explore the evidence to make a difference!

Best Regards,

Veronica Carter

Program Manager | Stem Cells 2019

E: stemcellresearch(at)pulsusglobalevents(dot)com

Ph: 44-203-769-1778

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International Conference on Stem Cells and Regenerative Medicine - Hoover Sun

WASHINGTON, D.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM) today released its most recent quarterly sector report, offering an in-depth look at cell therapy, gene therapy, tissue engineering, and broader global regenerative medicine sector trends and metrics in the third quarter of 2019.

By further curating information provided by ARMs data partner Informa, the quarterly sector report details industry-specific statistics compiled from 959 cell therapy, gene therapy, tissue engineering, and other regenerative medicine therapeutic developers worldwide, including total financings, partnerships and other deals, clinical trial information, key clinical data events, and ARMs current strategic priorities.

Amanda Micklus, a senior consultant for Pharma Intelligence at Informa, provided an overview of the commercial, clinical, and regulatory environment in the third quarter of 2019. The report also features commentary from founding members of ARM in honor of the organizations 10-year anniversary. Excerpts from panels at ARMs 2019 Meeting on the Mesa included in the report highlight the continued progress and innovation in the sector.

Highlighted findings from the Q3 2019 data report include:

ARM will continue to update this information through new reports to be released after the close of each quarter, tracking sector performance, key financial information, clinical trials by phase, and significant clinical data events.

The report isavailable online here, with interactive data and downloadable graphics from the reportavailable here. For more information, please visitwww.alliancerm.orgor contact Lyndsey Scull at lscull@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

Lyndsey Scull202 213 7086lscull@alliancerm.org

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The Alliance for Regenerative Medicine Releases Q3 2019 Sector Report, Highlighting Industry Trends and Metrics - BioSpace

The question remains unanswered as to whether a peer-to-peer collaborative model will prosper where medtech companies that are in some instances one step ahead of big pharma in terms of drug development are happy to be a third- party provider to big pharma that have the budgets and networks to truly deliver the regenerative medicine revolution.

In a recent document published by the UK government in response to the Regenerative Medicine Inquiry by the House of Commons Science and Technology Committee, policymakers stressed the importance of commercialising new therapies to meet the changing needs of the health sector.

In the UK, the Regenerative Medicine Expert Group (RMEG) has been tasked with developing an NHS regenerative medicine strategy to ensure the NHS is fully prepared to deliver innovative treatment and that regulations support and not hinder its delivery.

The Cell and Gene Therapy Catapult is also continuing to work to bridge the gap between translational research and commercialisation.

However, for the UK to be well-positioned to offer safe and effective regenerative therapies, a strategy is needed that covers the whole value chain from academic research, commercial development and clinical application.

The effect of Brexit on the UKs regenerative medicine sector remains unclear, but the UK has the opportunity to develop an independent framework outside the EU regulatory system to accelerate the development of new therapies and its economic potential while upholding the highest patient safety standards.

In any case, EU and UK regulators need to prioritise the standardisation of regulations governing manufacturing, quality control and the supply chain to keep up with advancements made by the FDA in the US.

Establishing an efficient supply chain for regenerative medicine

The promise of regenerative medicine requires an innovative look at the complete product life cycle, including the development of an efficient distribution network.

Once these novel drugs become mainstream, the entire healthcare ecosystem will have to adapt. Regulatory approval for any drug relies on it safely and successfully fulfilling its medical intent.

As such, information about supply chain management needs to be submitted to the regulator after the completion of phase 3 clinical trials, including packaging, labelling, storage and distribution.

The clinical supply chains required to deliver these therapies are arguably the most complex the industry has seen so far. Regenerative medicine is either personalised or matched to the donor-recipient. They are also highly sensitive to exogenous factors like time and temperature.

Advanced IT solutions and monitoring systems are being developed and employed to ensure end-to-end traceability. These are giving clinicians access to view the progress of therapies and their distribution in real-time and allow users to automatically schedule or amend material collections in line with manufacturing capacity, helping to keep the supply chain as agile as possible.

The live tissues and cells which form the basis of regenerative medicine products are highly sensitive and some have a shelf life of no more than a few hours.

Therefore, materials need to be transported from the site of harvest to manufacturing facilities, and from manufacturing facilities to medical institutions under strictly controlled conditions, within certain times and temperatures, according to cell and tissue requirements.

Temperature-controlled logistics solutions are vital to ensure a safe, effective and financially viable supply chain network for these high-value shipments. Cryopreservation is one technique increasingly being used to deliver medicines at optimum temperature using vapour phase nitrogen; however, many clinical settings remain ill-equipped to handle such equipment.

On-site production is an alternative manufacturing arrangement, particularly for autologous products which are derived from a patients own cells.

However, this throws up a number of compliance and infrastructure challenges, as the hospital would need to comply with a host of regulations including installing a Good Manufacturing Practice (GMP)-licensed clean room.

As a first-generation technology, stakeholders will have a greater tolerance for higher pricing... but only for a limited time period. By streamlining the currently very expensive manufacturing process and improving supply chain management, yields will automatically get larger and costs will slowly come down.

While there are many challenges in the road ahead, 2019 certainly appears to be the start of regenerative medicines move to the big time.

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Delivering the promise of regenerative medicine - PMLiVE

New York City, NY: November 05, 2019 The recent update in WorldwideRegenerative Medicine Market begins with description of the merchandise, definition, classification specifications and scope of product Regenerative Medicine market outlook. The Regenerative Medicine report provides forecast amount from 2019 to 2028. It also includes a radical analysis of worldwide market static knowledge, growth factors and geographical region-wise analysis, the highest manufacturers/major players.

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To access the sample report, click here:https://marketresearch.biz/report/regenerative-medicine-market/request-sample

which can be helpful to require decisive judgement of business on Regenerative Medicine market and increase the ratio. the primary five-year accumulative revenue (20192023) of Regenerative Medicine market is projected to be US$ XX Mn, and latter 5 years (20242028) revenue is projected to be US$ XX Mn is calcualted during this report.

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Global Regenerative Medicine Market 2019 covers following leading manufacturers:

Organogenesis Inc, Osiris Therapeutics Inc, Pfizer Inc, Novartis AG, Vericel Corporation, NuVasive Inc, Cook Biotech Inc, GlaxoSmithKline plc., Boehringer Ingelheim GmbH, Amgen Inc

Key features of Regenerative Medicine market:

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This content has been distributed via WiredRelease press release distribution service. For press release service enquiry, please reach us at[emailprotected].

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Regenerative Medicine Market Risk Factors, Growth Analysis, Market Size and Innovations By 2028 - 5Gigs News

HAIFA, Israel, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (ATSM), which is being held November 25-26, 2019 in Berlin. As a leading member of the large-scale research initiative, Pluristem, along with additional respected members, is committed to accelerating the availability of advanced therapies to all those in need, a main motivation standing behind RESTORE.

Led by Charit-Universittsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH-Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need. Advanced Therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health, said Prof. Volk. We are determined to translate promising research findings into safe therapies, and we are working across disciplines and national borders in order to achieve this goal. The 1st Advanced Therapies Science Meeting provides the opportunity to discuss the still numerous obstacles in the way of implementing these promising therapies in routine clinical care.

This initiative may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, said Zami Aberman, Executive Chairman of Pluristem. The European Commission is poised to make a significant investment of up to 1 billion in a consortium of companies that can drive forward the development of novel regenerative therapies, and we are pleased to be a leading part in this effort. Given our proprietary cell manufacturing technology and broad, late-stage pipeline, we believe we can play a key role toward making the transforming promise of advanced therapies into a reality.

The 1st ATSM will bring together experts from industry, patient organizations and academia to discuss the challenges within the field of advanced therapies, which include gene and cell therapies and tissue-engineering approaches. The ATSM is focused on trying to drive forward a concerted interdisciplinary effort, making use of science, infrastructure and funding within Europe to make regenerative therapies available to the broadest possible patient population.

The two-day program will include talks from Nobel Prize winner Ada Yonath (Director of Weizmann Institute of Science, Israel), Michele De Luca (University of Modena, Italy), Timothy OBrien (National University of Ireland, Galway, Ireland), Maksim Mamonkin (Baylor College of Medicine, USA), Manuela Gomes (University of Minho, Portugal) and others.

RESTORE partners include the Charit Universittsmedizin Berlin and Berlin Institute of Health (Germany), the University of Zurich (Switzerland), Cell and Gene Therapy Catapult (United Kingdom), TissUse GmbH (Germany), Pluristem (Israel), Miltenyi Biotec GmbH (Germany), INSERM Institut National de la Sant et de la Recherche (France), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal).

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the potential for the RESTORE Consortium to receive up to a 1 billion award by the European Commission and the timing of the potential award, that RESTOREs aim is to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need, that RESTORE and the 1st ATSM may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, and its belief that given its proprietary cell manufacturing technology and broad, late-stage pipeline, it believes it can play a key role toward making the transforming promise of advanced therapies into a reality. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

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RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting, Aiming to Translate Promising Research into a Game Changer in Healthcare -...