Category Archives: Regenerative Medicine

The recently published market study by MRRSE highlights the current trends that are expected to influence the dynamics of the Regenerative Medicine market in the upcoming years. The report introspects the supply chain, cost structure, and recent developments pertaining to the Regenerative Medicine market in the report and the impact of the COVID-19 on these facets of the market. Further, the micro and macro-economic factors that are likely to impact the growth of the Regenerative Medicine market are thoroughly studied in the presented market study.

According to the report, the Regenerative Medicine market is expected to grow at a CAGR of ~XX% during the forecast period, 20XX-20XX and attain a value of ~US$ XX by the end of 20XX. The report is a valuable source of information for investors, stakeholders, established and current market players who are vying to improve their footprint in the current Regenerative Medicine market landscape amidst the global pandemic.

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Critical Data in the Regenerative Medicine Market Report

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Regional Assessment

The regional assessment chapter in the report offers an out and out understanding of the potential growth of the Regenerative Medicine market across various geographies such as:

Application Assessment

The presented study ponders over the numerous applications of the Regenerative Medicine and offers a fair assessment of the supply-demand ratio of each application including:

segmented as follows:

Regenerative Medicine (Bone and Joint) Market, by Technology

Regenerative Medicine (Bone and Joint) Market, by Application

Regenerative Medicine (Bone and Joint) Market, by Geography

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Impact of COVID-19 Outbreak on Regenerative Medicine Market with Global Innovations, Competitive Analysis, New Business Developments and Top Companies...

CHICAGO,May 20, 2020/PRNewswire/ Brian J. Cole, M.D., M.B.A, sports medicine surgeon and Managing Partner atMidwest Orthopaedics atRush,has been named President of theArthroscopy Association ofNorth America(AANA) for the 2020-2021 term. His new role is effective immediately.

I am truly honored to serve in this capacity for the AANA, explains Dr. Cole, who also serves as Associate Chairman and Professor in the Department of Orthopedics, Director of the Cartilage Restoration Center, and head of the Orthopedic Masters Training Program atRush UniversityMedical Center. Im grateful to have been selected by my peers who are some of the most talented orthopedic surgeons in the country.

A primary issue of focus for Dr. Cole and the AANA Board of Directors will be to encourage the development of additional research support, adapting educational initiatives to the current environment, advocacy, and providing practice management services for its nearly 6,000 members.

Dr. Cole also serves as the Chairman, Department of Surgery at Rush Oak Park Hospital; Head Team Physician for the Chicago Bulls; and Team Physician for the Chicago White Sox. He is the co-host of Sports Medicine Weekly on670AM The ScoreinChicagoand the Physician Director of the annualChicago Sports Summit.

He lectures nationally and internationally and holds several leadership positions in prominent sports medicine societies.Through his basic science and clinical research, he has developed several innovative techniques for the treatment of shoulder, elbow and knee conditions. He haspublished more than 1,000 articles and 10 widely read textbooks in orthopedicsand regenerative medicine.

Dr. Cole is frequently chosen as one of theBest Doctors in Americasince 2004 and as a Top Doctor in theChicagometro area since 2003. He was featured on thecover ofChicago Magazineas ChicagosTop Doctor and has been selected asNBA Team Physician of the Year.Orthopedics This Weeknamed Dr. Cole as one of the top 20 sports medicine, knee and shoulder specialists repeatedly over the last five years as selected by his peers.

SOURCE Midwest Orthopaedics atRush

http://www.rushortho.com

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Dr. Brian J. Cole Named President of the Arthroscopy Association of North America - OrthoSpineNews

This photo provided by the National Center for Child Health and Development shows liver cells produced from embryonic stem cells.This photo provided by the National Center for Child Health and Development shows human embryonic stem cells.

The National Center for Child Health and Development in Tokyo announced it has successfully conducted a clinical trial to transplant liver cells created from human embryonic stem cells into a baby with a serious liver condition.

It is the first clinical trial in Japan to use human embryonic stem cells, and is also believed to be the first case in the world of liver cells produced from embryonic stem cells being transplanted into a person.

The baby that received the transplant had hyperammonemia, a condition in which an abnormality in the natural urea cycle prevents toxic ammonia from being broken down in the liver. The abnormality is said to be prevalent in between one in 8,000 and one in 44,000 people.

In serious cases a liver transplant is required to treat it, but newborns have a high risk of experiencing major side effects. As a result, transplants cannot be conducted safely until several months after birth, when the baby weighs 6 kilograms or more.

In Europe and North America, doctors have utilized translational medicine, in which normally functioning liver cells are transplanted into newborns, to keep the liver functioning until an organ transplant can be carried out. In Japan, the National Center for Child Health and Development has previously transplanted liver cells from living donors into newborns with the condition soon after birth, but it has had difficulty in steadily securing liver cells.

Because of this, the center drew up plans to create liver cells from embryonic stem cells and transplant them. Over a period of two days in October 2019, it injected about 190 million liver cells into blood vessels in the umbilical cord of a 6-day-old newborn with hyperammonemia. The ammonia concentration in the infant's blood then stopped rising, enabling researchers to confirm that the liver cells had reached the newborn's liver, and the baby was temporarily discharged from the hospital.

Five months later, when the baby weighed 7 kilograms, a living donor liver transplant was carried out with the baby's father serving as the donor. The baby was again able to be discharged from the hospital in late April.

The center has received approval from the national government to use liver cells derived from embryonic stem cells in regenerative medicine, and plans to transplant them into several people subject to clinical trials in the future.

Center official Mureo Kasahara of the national center's organ transplant center commented, "It was often the case that babies with this condition died from seizures or suffered brain damage before the liver transplant could take place. The latest case is hugely significant in that we have proved the effectiveness of the method."

(Japanese original by Ayumu Iwasaki, Science & Environment News Department)

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1st transplant using liver cells from embryonic stem cells conducted on baby in Japan - The Mainichi

The results of a new clinical trial published in the journal STEM CELLS Translational Medicine demonstrate how a topical solution made up of stem cells leads to the regrowth of hair for people with a common type of baldness.1

Unfortunately, there are only a few FDA-approved medications to treat hair loss, and these carry a myriad of associated side effects including a negative impact on sexual functioning. There is therefore a pertinent need to develop anti-hair loss treatments that lack such side effects.

Emerging research has demonstrated the potential application of stem cells, particularly adipose tissue-derived stem cells (ADSCs), in this space. ADSCs are a type of mesenchymal stem cell that secrete several growth hormones that facilitate cell development and proliferation.

As previous research has demonstrated that growth factors such as hepatocyte growth factor, vascular endothelial growth factor, insulin-like growth factor and platelet-derived growth factor increase the size of hair follicles during hair development, scientists have explored whether ADSCs can promote hair growth in men and women with alopecia.2,3 The results of such research have been positive, however, a randomized, placebo-controlled trial of such a therapeutic approach in AGA did not exist until now.

"Recent studies have shown that ADSCs promote hair growth in both men and women with alopecia. However, no randomized, placebo-controlled trial in humans has explored the effects and safety of adipose-derived stem cell constituent extract (ADSC-CE) in AGA," says Sang Yeoup Lee, M.D., Ph.D., of the Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital. "We aimed to assess the efficacy and tolerability of ADSC-CE in middle-aged patients with AGA in our study, hypothesizing that it is an effective and safe treatment agent."

Participants were instructed to apply 2mL of solution to the area in which they experienced hair loss, twice every day for a total of 16 weeks, massaging the solution into their scalp using their fingers. Each subjected visited the research center four times in total throughout the study, and were requested to keep a diary to record when they were using the solution.

To measure whether the solution was significantly impacting hair growth, the scientists measured changes in total hair number and hair thickness as confirmed by close contract photographs using a standardized technique. This was the primary efficacy variable. Photographs were taken at baseline, eight weeks and 16 weeks after using the product. At baseline, participants received a dot tattoo over their scalp to ensure that the photographs were taken at the same spot at each follow up. The secondary efficacy variables of the study included analysis of global photographs of the participants' scalps by an investigator, and self-evaluation of hair growth by the participants.

Whilst these results are promising, the authors note several limitations to the study. When assessing the secondary efficacy outcomes, the researchers found that the improvement score provided by the investigator was higher in the intervention group than the control, but this was not a significant increase. Additionally, the evaluation provided by the subject was lower in the intervention group. The scientists suggest that a contributing factor here could be the study duration, positing the idea that the length of time in which the participants were involved in the trial may not have been sufficient for them to notice a visual improvement. Furthermore, the self-report assessment could have been limited in validity as subjects may have been impacted by their own expectations towards the intervention. A solution to consider going forward could be to ask participants about their expectations regarding the magnitude of improvement at baseline.

Lee adds, "Our findings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety. The next step should be to conduct similar studies with large and diverse populations in order to confirm the beneficial effects of ADSC-CE on hair growth and elucidate the mechanisms responsible for the action of ADSC-CE in humans."

"For the millions of people who suffer from male-pattern baldness, this small clinical trial offers hope of a future treatment for hair regrowth," says Anthony Atala, M.D., Editor-in-Chief ofSTEM CELLS Translational Medicineand director of the Wake Forest Institute for Regenerative Medicine. "The topical solution created from proteins secreted by stem cells found in fat tissue proves to be both safe and effective. We look forward to further findings that support this work."

References:

1. Tak, Lee, Cho and Kim. (2020). A randomized, doubleblind, vehiclecontrolled clinical study of hair regeneration using adiposederived stem cell constituent extract in androgenetic alopecia. Stem Cells Translational Medicine. DOI: https://doi.org/10.1002/sctm.19-0410.

2. Ramdasi S, Tiwari SK. (2016). Growth factors and cytokines secreted in conditioned media by mesenchymal stem cells-promising possible therapeutic approach for hair regeneration. J Stem Cells. https://www.ncbi.nlm.nih.gov/pubmed/28296872.

3. Lee et al. (2001). Hepatocyte growth factor (HGF) activator expressed in hair follicles is involved in in vitro HGF-dependent hair follicle elongation. J Dermatol Sci. 25:156-163.

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Clinical Trial Shows Topical Stem Cell Treatment Leads to Hair Regrowth in Common Type of Baldness - Technology Networks

DNA may not be lifes instruction book, but just a jumbled list of ingredients.

University of Maryland researcher develops potentially revolutionary framework for heredity and evolution in which inheritable information is stored outside the genome.

The common view of heredity is that all information passed down from one generation to the next is stored in an organisms DNA. But Antony Jose, associate professor of cell biology and molecular genetics at the University of Maryland, disagrees.

In two new papers, Jose argues that DNA is just the ingredient list, not the set of instructions used to build and maintain a living organism. The instructions, he says, are much more complicated, and theyre stored in the molecules that regulate a cells DNA and other functioning systems.

Jose outlined a new theoretical framework for heredity, which was developed through 20 years of research on genetics and epigenetics, in peer-reviewed papers in the Journal of the Royal Society Interface and the journal BioEssays. Both papers were published on April 22, 2020.

Joses argument suggests that scientists may be overlooking important avenues for studying and treating hereditary diseases, and current beliefs about evolution may be overly focused on the role of the genome, which contains all of an organisms DNA.

DNA cannot be seen as the blueprint for life, Jose said. It is at best an overlapping and potentially scrambled list of ingredients that is used differently by different cells at different times.

For example, the gene for eye color exists in every cell of the body, but the process that produces the protein for eye color only occurs during a specific stage of development and only in the cells that constitute the colored portion of the eyes. That information is not stored in the DNA.

In addition, scientists are unable to determine the complex shape of an organ such as an eye, or that a creature will have eyes at all, by reading the creatures DNA. These fundamental aspects of anatomy are dictated by something outside of the DNA.

Jose argues that these aspects of development, which enable a fertilized egg to grow from a single cell into a complex organism, must be seen as an integral part of heredity. Joses new framework recasts heredity as a complex, networked information system in which all the regulatory molecules that help the cell to function can constitute a store of hereditary information.

Michael Levin, a professor of biology and director of the Tufts Center for Regenerative and Developmental Biology and the Allen Discovery Center at Tufts University, believes Joses approach could help answer many questions not addressed by the current genome-centric view of biology. Levin was not involved with either of the published papers.

Understanding the transmission, storage and encoding of biological information is a critical goal, not only for basic science but also for transformative advances in regenerative medicine, Levin said. In these two papers, Antony Jose masterfully applies a computer science approach to provide an overview and a quantitative analysis of possible molecular dynamics that could serve as a medium for heritable information.

Jose proposes that instructions not coded in the DNA are contained in the arrangement of the molecules within cells and their interactions with one another. This arrangement of molecules is preserved and passed down from one generation to the next.

In his papers, Joses framework recasts inheritance as the combined effects of three components: entities, sensors and properties.

Entities include the genome and all the other molecules within a cell that are needed to build an organism. Entities can change over time, but they are recreated with their original structure, arrangement and interactions at the start of each generation.

That aspect of heredity, that the arrangement of molecules is similar across generations, is deeply underappreciated, and it leads to all sorts of misunderstandings of how heredity works, Jose said.

Sensors are specific entities that interact with and respond to other entities or to their environment. Sensors respond to certain properties, such as the arrangement of a molecule, its concentration in the cell or its proximity to another molecule.

Together, entities, sensors and properties enable a living organism to sense or know things about itself and its environment. Some of this knowledge is used along with the genome in every generation to build an organism.

This framework is built on years of experimental research in many labs, including ours, on epigenetics and multi-generational gene silencing combined with our growing interest in theoretical biology, Jose said. Given how two people who contract the same disease do not necessarily show the same symptoms, we really need to understand all the places where two people can be differentnot just their genomes.

The folly of maintaining a genome-centric view of heredity, according to Jose, is that scientists may be missing opportunities to combat heritable diseases and to understand the secrets of evolution.

In medicine, for instance, research into why hereditary diseases affect individuals differently focuses on genetic differences and on chemical or physical differences in entities. But this new framework suggests researchers should be looking for non-genetic differences in the cells of individuals with hereditary diseases, such as the arrangement of molecules and their interactions. Scientists dont currently have methods to measure some of these things, so this work points to potentially important new avenues for research.

In evolution, Joses framework suggests that organisms could evolve through changes in the arrangement of molecules without changes in their DNA sequence. And in conservation science, this work suggests that attempts to preserve endangered species through DNA banks alone are missing critical information stored in non-DNA molecules.

Jose acknowledged that there will be much debate about these ideas, and experiments are needed to test his hypotheses. But, he said, preliminary feedback from scientists like Levin and other colleagues has been positive.

Antony Joses generalization of memory and encoding via the entity-sensor-property framework sheds novel insights into evolution and biological complexity and suggests important revisions to existing paradigms in genetics, epigenetics and development, Levin said.

###

References:

A framework for parsing heritable information by Antony M. Jose, 22 April 2020, Journal of the Royal Society Interface.DOI: 10.1098/rsif.2020.0154

Heritable Epigenetic Changes Alter Transgenerational Waveforms Maintained by Cycling Stores of Information by Antony M. Jose, 22 April 2020, BioEssays.DOI: 10.1002/bies.201900254

Research in Antony Joses laboratory is supported by the National Institutes of Health (Award Nos. R01GM111457 and R01GM124356). The content of this article does not necessarily reflect the view of this organization.

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DNA May Not Be the Blueprint for Life Just a Scrambled List of Ingredients - SciTechDaily

May21, 20205 min read

Opinions expressed by Entrepreneur contributors are their own.

Education is the crucial step in opening up consumer marketplaces for hemp-based products.

CEO and co-founder of SilverLeaf Global, Gil Laureiros career is deep-rooted in identifying innovative products. His work also ensureseach is certified safe and effective prior to introducing the product into the market. Laureiro has been directly involved with guiding many products through the FDA clearance process. He is at it again.

A big believer in scientific, research-backed health benefits, Laureiro has immersed himself into hemp-based solutions.

RELATED:The 35 Most Influential Women In Cannabis

What many people dont realize is that the endocannabinoid system of all mammals vertebrates and invertebrates work the same, said Laureiro. His company SilverLeaf Global isthe foundational platform for NanoSol Pro and NanoSol Pet hemp-based products.

Our goal for ourselves and our furry friends are safe and verifiable products that promote our cells to work optimally, also called 'cellular optimization,'" says Laureiro. "We accomplish cellular optimization through cellular supplementation and thereby, minimize cellular disruption. Said differently, NanoSol formula is designed to optimize cellular activity by minimizing endocannabinoid deficiencies.

While many CBD producers have product lines for pets, Laureiro and his partners at NanoSol Pet set out at the onset to design and formulate hemp-based products intended to promote better health and lifestyle for our four-legged friends.

Laureiro says:We want to educate the public about the health benefits of CBD for our pets. A large portion of our website and marketing efforts are focused on just this.Research is still ongoing.

Green Entrepreneur spoke with SilverLeaf Global'sLaureiro on why focusing on pets was the company's next move, what humans and our pets have in common, and how to find proper dosing.

Green Entrepreneur:Why did you get into CBD? Why pets?

Gil Laureiro: My co-founders and I have spent years advancing healthcare solutions pertaining to both human and pet medical markets. We expanded our business strategy in adopting hemp-based products due to their ability to non-invasively and significantly contribute to cellular optimization. Our hemp product initiative is directly influenced by our business development experience and expertise in the FDA cleared field of non-invasive cellular regenerative medical device solutions launched into the healthcare market.

Both non-invasive cellular regenerative medical devices and hemp-based products contain similarity in that they provide diagnostic and therapeutic solutions to both the animal and human medicine and health optimization markets. Like humans, animals as scientifically proven contain an endocannabinoid system and suffer similar symptoms when the endocannabinoid system becomes deficient.

How does an animals endocannabinoid system work?

Both humans and animals contain anendocannabinoid system (ECS), comprised of cannabinoid receptors, endocannabinoid molecules, and their metabolic enzymes. Together they comprise a crucial molecular system that the body uses to help maintain homeostasis.

The endocannabinoid system is recognized as an important modulatory system that directly affects the function of the brain, endocrine, and immune tissues. Cannabidiol hemp oil acts through cannabinoid receptors located on cells throughout an animals body, which address deficiencies of the endocannabinoid system.

RELATED:CBD For Dogs Is The Next Big Thing In The Supplement Industry

Cannabinoids affect the pets body, as they contain receptors that are made to bind to specific cannabinoid molecules.

How is the animal endocannabinoid system different than humans? How are they the same?

The human and animal endocannabinoid system very similar regarding its intended function and symptoms experienced from a deficiency. Hemp oil supplementation health benefits similar to animals and very much the same for humans.

Humans often dont know if they are taking full spectrum or broad-spectrum hemp oil. Does this matter for animals?

Full Spectrum hemp oils, by definition, contain small traceamounts of THC and when the hemp is processed butthe THC present is not filtered out. Broad Spectrum processes hemp a step further to ensure THC is removed and therefore when tested, no trace amounts of THC are detectable. Science tells us that any tracible amounts of THC ingested are cumulative and may be harmful and therefore, pets should only take broad-spectrumhemp oil.

To ensure you are buying a non-detect THC product, a Certificate of Analysis (COA) should accompany the product and the COA must be provided by a certifiable independent testing laboratory.

We know dosing for humans can sometimes be a matter of trial and error. What about hemp oil dosing for animals?

Pet dosing is calculated by weight and dosing should be clearly suggested on the product label. No different than humans, observing your pet during the first few weeks of dosing helps you determine if the applied dose is working, or possibly the dosing should be increased or decreased.

RELATED:6 Convincing Reasons Why USDA Organic Certification For CBD Is The Trend To Watch

Do vets recommend hemp oil for pets?

Hemp oil recommendations by veterinarians vary from state to state. This said, there are a large number of veterinary practices that not only recommend hemp oil for pets butcarry the product in their practice and sell directly to their clients. Many studies are being conducted due to the empirical evidence already obtained, that supplementing with hemp oil may contain a number of animal health benefits. The most common being inflammation andpain reduction.

The more these studies are made public or published, the more veterinarians will recommend hemp oil supplementation.

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Education Is Key In Marketing Hemp Oil And CBD For Pets. Here's Why. - Green Entrepreneur

To deal with the challenges in regenerative medicine, in 2018, pioneer bioprinting expert Anthony Atala announced the foundation of an organization dedicated solely to advancing the field through manufacturing. Known as the Regenerative Medicine Manufacturing Society (RMMS), it is the first collaborative effort that aspires to help deliver regenerative medicine products to the marketplace. In particular, the RMMS recently announced that working groups of researchers representing industry, government, academia, and non-profit organizations will identify current gaps and solution spaces in regenerative medicine to improve patient outcomes; and among the four impact areas they will investigate, is 3D bioprinting.

RMMS members will share their knowledge and work together to create solutions to manufacturing challenges. The ultimate goal is to develop standardized manufacturing processes to facilitate the smooth and quick transition of new therapies to market, thereby ensuring patient access.

The four impact areas that the societys leadership team has identified as critical in regenerative medicine are cell manufacturing; standards for regenerative medicine; 3D bioprinting; and artificial intelligence-enabled automation.

According to a paper published in Stem Cells Translational Medicine the official journal of the RMMS the working groups will help evaluate the current landscape of work already done in both regenerative medicine and related fields, including cell therapy manufacturing, as well as identify gaps, and propose solution spaces for the field to focus on. One of the targets of their upcoming work will be the development of safety and quality industry standards specifically for regenerative medicine manufacturing.

More precisely, and as far as 3D bioprinting is concerned, the RMMS working groups will look into the development of bioink standards and assist with understanding some of the regulatory hurdles of creating combination products, such as implants consisting of a scaffold and living cells.

Emerging as a powerful tool for building tissue and organ structures, the use of 3D bioprinting technology and the development of user-friendly software platforms have grown tremendously in the past five years. However, experts at the RMMS suggest that the advancement of out of the box customized bioinks that can be sold in tandem with this technology is lagging behind.

Furthermore, the RMMS paper hones in on some of the known materials that are being developed for use across different bioprinting platforms that have ultimately demonstrated a trade-off between printability and biological relevance, such as easier-to-print plant-based bioinks, or extracellular matrix (ECM) component bioinks that are more biologically relevant but more difficult to print.

To close this gap, the RMMS considers assisting organizations that are beginning to strategically circumvent these challenges, like ASTM International. Their work on bioink standards, including printability of bioinks and biomaterials, could be used in automated biofabrication technology, as well as guidance on the development of bioinks, including considerations such as material properties that assist with survival of cells within bioinks. All of this would ultimately lead to the development of new bioinks.

The second limiting factor that RMMS researchers wish to tackle is the regulatory hurdle of developing combination products. Using a 3D bioprinter to create implants consisting of a scaffold and living cells will need to go through review by both device and biologic regulatory agencies, which results in long and expensive regulatory approval pathways compared with the more traditional implants.

As many experts have suggested, regulation is a big issue in the bioprinting field. There are simply too many complex points to be considered with biomanufacturing and it appears that bioprinting research will always outpace the regulatory agencies ability to keep up; that is, unless the quality, risk and safety standards are clearly determined beforehand.

In that regard, the RMMS working groups will assist with understanding some of the regulatory challenges and technology gaps in this rapidly advancing area and highlight member-developed solutions.

RMMS researchers stated in the article that: We envision assisting with the advancement of commercial products with industry partners in this space based on recommendations from our working groups.

Moreover, some early clinical opportunities may include external regenerative medicine targets such as cell-based wound dressings.

Proposed as a collaborative work, the RMMS hopes to accelerate efforts in regenerative medicine manufacturing through partnerships with government, industry, and academia. The primary author of the paper and RMMS Executive Director, researcher Joshua Hunsberger, leads the group of researchers as they work with partners to identify areas where they can make an impact, as well as develop new education and training programs.

Joshua Hunsberger

Education and training are critical to RMMS goals as they expect to accomplish their mission through outreach and education programs and securing grants for public-private collaborations in regenerative medicine manufacturing. From expanding the current talent pool to promoting careers in regenerative medicine, education and training is key to adapt to the growing demands of the workforce in this emerging sector.

RMMS hopes to collaborate in developing learning networks across all levels of education, and in tune with their mission, identify gaps where they could assist in developing new training programs or expanding current ones. The areas they are considering are hands-on cell culture techniques, the latest manufacturing technology, analytical methods, and regulatory requirements.

As the worlds first professional organization dedicated solely to advancing the field of regenerative medicine through manufacturing, RMMS also serves as an information clearinghouse, supports professional and workforce development, and promotes the infrastructure for the fields success.

Back in 2018, during the RMMS inaugural meeting, founding member and director of the Wake Forest Institute for Regenerative Medicine (WFIRM), Atala, described how regenerative medicine therapies are already benefiting small groups of patients through clinical trials. Also revealing that while there is still much to accomplish scientifically, the field is at a tipping point. If we are going to bring high-quality, cost-effective therapies to patients, now is the time to begin the important work of developing the manufacturing processes. Collaboration between stakeholders is vital to success.

Certainly, RMMS is all about collaboration, focused on strengthening the framework of regenerative medicine by developing solutions to accelerate the commercialization of the latest technological advances and growing the workforce in a rapidly expanding sector. And with strong support from researchers coming together from the different branches that ultimately make up the field, it is difficult not to eagerly anticipate the results of this joint effort.

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RMMS: The Regenerative Medicine Manufacturing Society Will Target Unmet Needs in 3D Bioprinting - 3DPrint.com

Back injuries are no joke. Even minor muscle strains can inhibit activities for some time. More serious injuries create greater challenges and often require more stringent treatments, which is where companies like VIVEX Biologics play a significant role.

At the end of April, VIVEX published clinical data assessing VIA Disc as a potential treatment for symptomatic degenerative disc disease. VIVEXs VIA Disc is a non-surgical,injectable treatment option for patients suffering from chronic lower back pain resulting from DDD. Degenerative disc disease is the most common cause of chronic lower back pain in adults, which is the leading cause of disability across the globe, with a cost of about $87.6 billion. There are few treatment options for DDD, with most patients having to use opioids to manage the pain or surgery for patients who cannot manage their disease with medication.

To address this gap in the continuum of care, VIVEX developed VIA Disc to offer patients a novel, non-surgical intervention for treating one to two levels of symptomatic DDD. In the paper, VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease, which was published in The International Journal of Spine Surgery, trial data showed that VIA Disc improved pain and function in patients with DDD by greater than 70%, as measured by visual analog scale (VAS) and Oswestry Disability Index (ODI). Additionally, the data from the study showed that the results were durable one year following the treatment.

Peter Wehrly, chief executive officer of VIVEX, said the results are encouraging and validate the therapeutic potential of VID Disc in patients who are in critical need of treatment. The positive data from the study is exciting, particularly given the high, unmet need in this space, Wehrly told BioSpace in an interview. Not only is degenerative disc disease an area of unmet need, the number of patients is growing, Wehrly said. Currently, there are approximately 800,000 cases of DDD, but that continues to increase by about 20,000 each year, Wehrly said.

The study data will lead to the launch of an incremental trial that will follow patients over the course of three years. Wehrly said the data, which has so far looked promising, could prove to be enormously helpful to patients who are dealing with back pain day in and day out. Patients who have been treated with VIA Disc notice a difference almost immediately, he added.

Hopefully this helps patients for at least two years, he said, adding that he will be ecstatic should the studies support that.

Eventually, VIVEX will likely test potential re-administration of VIA Disc in patients who did benefit from an initial treatment. At this point though, Wehrly said the company has yet to delve into that possibility. He stressed that the company will take things one step at a time with VIA Disc as VIVEX has a goal to become the company in this space.

In order to support that goal, VIVEX has been planning an expansion of its footprint in Florida. The company plans to open a new 90,000 square foot facility this summer. It was a facility that VIVEXs employees helped design in order to make it as efficient as possible, Wehrly told BioSpace.

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VIVEX to Expand Footprint in Florida to Support Regenerative Medicine Technologies - BioSpace

The demand within the global stem cell banking market is growing on account of advancements in the field of regenerative medicine. The medical fraternity has become extremely focused towards the development of artificial tissues that can infuse with the human body. Furthermore, medical analysis and testing has gathered momentum across biological laboratories and research institutes. Henceforth, it is integral to develop stem cell samples and repositories that hold relevance in modern-day research. The need for regenerative medicine emerges from the growing incidence of internal tissue rupture. Certain types of tissues do not recover for several years, and may even be damaged permanently. Therefore, the need for stem cell banking is expected to grow at a significant pace.

In a custom report, TMR Research digs into the factors that have aided the growth of the global stem cell banking market. The global stem cell banking market can be segmented on the basis of bank size, application, and region. The commendable developments that have incepted across the US healthcare industry has given a thrust to the growth of the North America stem cell banking market.

Global Stem Cell Banking Market: Notable Developments

The need for improved regenerative medication and anatomy has played an integral role in driving fresh developments within the stem cell banking market.

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Gallant has emerged as a notable market entity that has remained as the torchbearer of innovation within the global stem cell banking market. The company has recently launched stem cell banking for dogs, and has attracted the attention of the masses. As people become increasingly concerned about their pets, the new move by Gallant shall help the company in earning the trust of the consumers. Moreover, it can move several notches higher on the innovation index.

Cells4Life has also remained at the forefront of developments within the global stem cell banking market. After suffering backlash for its error in cord blood stem cell promotion, the company is expected to use effective public relation strategies to regain its value in the market.

Global Stem Cell Banking Market: Growth Drivers

Development of improved facilities for storage of stem cells has played an integral role in driving market demand. Furthermore, the unprecedented demand for improved analysis of regenerative medications has also created new opportunities within the global stem cell banking market. Medical research has attracted investments from global investors and stakeholders. The tremendous level of resilience shown by biological researchers to develop stem cell samples has aided market growth. Henceforth, the total volume of revenues within the global stem cell banking market is slated to multiply.

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Commercialization of stem cell banks has emerged as matter of concern for the healthcare industry. However, this trend has also helped in easy storage and procurement of cells stored during the yester years of children. Presence of sound procedures to register at stem cell banks, and the safety offered by these entities, has generated fresh demand within the global market. New regional territories are opening to the idea of stem cell banking. Several factors are responsible for the growth of this trend. Primarily, improvements in stem cell banking can have favourable impact on the growth of the healthcare industry. Moreover, the opportunities for revenue generation associated with the development of functional stem cell banks has aided regional market growth.

The global stem cell banking market is segmented on the basis of:

Source

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Stem Cell Banking Market - Need for Improved Regenerative Medication and Anatomy - BioSpace

The Indiana University School of Medicine established itself as a leader in regenerative medicine when it recruited Chandan Sen away from Ohio State University in 2018. (Photo courtesy of the IU School ofMedicine)

A dime-size nanochip developed by a world-renowned researcher who recently relocated to Indianapolis could help transform the practice of medicine. It could also turn Indianapolis into a manufacturing and research hub for radically new disease and trauma treatment techniques.

It all began in August 2018, when Chandan Sen, one of the worlds leading experts in the nascent field of regenerative medicine, moved his lab from Ohio State University to the Indiana University School of Medicine. He brought along a team of about 30 researchers and $10 million in research grants, and now serves, among a myriad of other positions, as director of the newly formed Indiana Center for Regenerative Medicine and Engineering, to which IU pledged $20 million over its first five years.

IU recruited Sen away from Ohio State in part because of its desire not just to promote academic research in his field but also to help develop practical, commercial products and uses for hisbreakthroughs.

A scientist prefers to be in the lab and keep on making more discoveries, said Sen, 53.

But I thought that, unless we participate in the workforce development process and the commercialization process, I dont think that the businesspeople would be ready to do it all by themselves. Because its such a nascentfield.

Its definitely newand its potential sounds like the stuff of science fiction.

Regenerative medicine, as its name hints, seeks to develop methods for replacing or reinvigorating damaged human organs, cells and tissues.

For instance, instead of giving a diabetic a lifetimes worth of insulin injections, some of his skin cells could be altered to produce insulin, curing him. Such techniques might also be used for everything from creating lab-grown replacement organs to, someday, regenerating severed limbs.

Regenerative medicine offers a form of medicine that is neither a pill nor a device, Sen said.

It is a completely new platform, where you dont necessarily depend on any given drug, but are instead modifying bodily functions.

A big, tiny breakthrough

Lambert

Sen and his teams signal contribution to the field is a technique theyve dubbed tissue nanotransfection, or TNT. Put simply, it uses a nanotechnology-based chip infused with a special biological cargo that, when applied to the skin and given a brief electrical charge, can convert run-of-the-mill skin cells into other cell types. Potentially, the technique could be used for everything from regrowing blood vessels in burn-damaged tissue to creating insulin-secreting cells that could cure diabetics.

Obviously, such applications are still down the road a ways. But the technology is far enough along that some products are already making it to marketand investors, entrepreneurs and established companies are sniffing around for opportunities. According to the Alliance for Regenerative Medicine, more than 1,000 clinical trials worldwide are using regenerative medicine technologies.

Thousands of patients are already benefiting from early commercial products, and we expect that number will grow exponentially over the next few years, said Janet Lambert, the alliances CEO.

Lambert predicts that the number of approved gene therapies will double in the next one to two years. Last year, the U.S. Food and Drug Administration predicted it would be approving 10 to 20 cell and gene therapies each year by2025.

Shekhar

These new techniques could do more than just revolutionize medicine. They could also upend the medical industry as we know it. And the IU School of Medicineand Indianapoliscould lead the way.

There are really only two or three places in the country that did the kind of comprehensive work that Dr. Sens group was doing, said Anantha Shekhar, executive associate dean for research at IU School of Medicine. And they were doing it from the lab all the way to the clinic, where they were already applying those technologies in patients.

So it was very attractive to think of starting with a bangbringing a comprehensive group here and creating a new center.

Ambitious goals

Instead of merely treating chronic conditions, regenerative medicine could end them, once and for all.

For instance, consider a car with an oil leak. The traditional medical approach might be to live with the chronic condition by pouring in a fresh quart of oil every few days. The regenerative medicine approach would fix the leak. Its good for the car, good for the cars owner but not necessarily good for the guy who was selling all those quarts of oil.

Which is why these new techniques, if they catch on, could cause turmoil in the medical industry.

Because regenerative medicine has the potential to durably treat the underlying cause of disease, rather than merely ameliorating the symptoms, this technology has the potential of being extremely disruptive to the current practice of medicine, Lambert said.

This has the potential to be hugely disruptive, Sen added, because so much of medicine today relies on huge industrial infrastructures to manage, not cure, chronic diseases and disabilities.

Coy

If such disruption comes to pass, the leaders of 16 Tech, a 50-acre innovation district northwest of downtown that aspires to house dozens of medical-related startups and established firms, would love to be its epicenter.

The Center for Regenerative Medicine will be one of the tenants of 16 Techs first building, a $30million, 120,000-square-foot research and office building scheduled to open in June.

Regenerative medicine is probably one of the next major waves of medical innovation in the world, 16 Tech CEO Bob Coy said. To have him here doing this work gives Indianapolis and Indiana an opportunity to develop an industrial cluster in regenerative medicine.

Coy believes the most momentous early step on that road was the recent establishment by Sen of masters and doctoral programs in regenerative medicine at the IU School of Medicine. Its the first degree of its type in the country, earning IU and Indianapolis the enviable status of first mover.

I think, for example, of [Pittsburghs] Carnegie Mellon University, which, back in the late 1960s, created the first college of computer science in the country, Coy said. And now you know Carnegie Mellons reputation in computerscience.

What isnt in place yet is a state or city program to promote development of a regenerative medicine hub.

We need to start doing that, Coy said. That means putting a lot of the infrastructure in place to support startups that are based on this technology, as well as recruiting companies that want to collaborate with Dr. Sen.

In spite of the lack of a coherent recruitment program, Coys phone has started to ring, thanks largely to Sens presence.

There have been a few meetings Ive had with people who already have relationships with him, who, when they come to town, have reached out to meet and talk about what were doing at 16 Tech, he said.

Fueling entrepreneurship

One of the first 16 Tech startups with designs on the regenerative medicine niche is Sexton Biotechnologies.

The company was groomed by Cook Regentec, a division of Bloomington-based Cook Group charged with incubating and accelerating technologies for regenerative medicine and the related field of cell genetherapy.

Any products that show promise are either folded into the company, turned into their own divisions or, as in Sextons case, spun off as an independent entity with Cook retaining a financial stake.

Werner

Its a measure of the newness of this field that Sextons 17 employees arent working on new medicines, but rather marketing basic tools needed to conduct research. The companys offerings include a vial for storing cell and gene products in liquid nitrogen, and a cell culture growth medium.

Theres a ready market for such tailor-made gear, because, for years, researchers in the regenerative medicine field had to make do with jury-rigged equipment.

What most of those companies did was repurpose things like tools from the blood banking industry, or tools from bio pharma, said Sean Werner, Sextons president.

So thats why a lot of newer companies are starting to build tools explicitly for the industry, as opposed to everybody just having to cobble together stuff that was already out there.

Werner said investors recognize the momentous opportunity in regenerative medicine and are flocking to the field.

Its not something you have to explain, he said. Companies and VC groups are trying to get a piece of it.

What has investors and medical researchers charged up is the almost unlimited range of potential applications, from healing burns to, perhaps someday, regenerating limbs.

I think it would be a huge revolution if were able to, for example, regenerate insulin-secreting cells in children who have become juvenile diabetics or have for whatever reason lost their pancreas, Shekhar said. Those are the kinds of things that will start to change the way we see certain diseases.

Lambert predicted that, as the science advances, so will the business case.

While early programs focused primarily on rare genetic diseases and blood cancers, were already seeing the field expand into more common age-related neurological disorders, such as Parkinsons and Alzheimers, shesaid.

I expect this trend to continue in the coming years, greatly increasing the number of patients poised to benefit from these therapies.

Werner said regenerative medicine also is seeking advancements in manufacturing technologies that will lower the cost of product development.

It all adds up to a huge opportunity the state is well-positioned to seize, Wernerbelieves.

Indiana is a perfect place for this kind of thing to really ramp up, he said. Theres no reason we cant lead thefield.

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IU team pursuing breathtaking advancements in regenerative medicine - Indianapolis Business Journal