StemCell Therapy

Dublin, Jan. 03, 2020 (GLOBE NEWSWIRE) -- The "Cell and Advanced Therapies Supply Chain Management Market, 2019-2030: Focus on Technological Solutions" report has been added to ResearchAndMarkets.com's offering.

Cell and Advanced Therapies Supply Chain Management Market: Focus on Technological Solutions, 2019-2030 report features an extensive study of the growing supply chain management software solutions market.

The focus of this study is on software systems, including cell orchestration platforms (COP), enterprise manufacturing systems (EMS), inventory management systems (IMS), laboratory information management systems (LIMS), logistics management systems (LMS), patient management systems (PMS), quality management systems (QMS), tracking and tracing software (TTS), and other such platforms that are being used to improve / optimize various supply chain-related processes of cell and advanced therapies.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the supply chain management software solutions market. Based on multiple parameters, such as number of cell and advanced therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different software systems, we have developed informed estimates of the evolution of the market, over the period 2019-2030.

In addition, we have provided the likely distribution of the current and forecasted opportunity across:

Advanced therapy medicinal products, such as cell and gene therapies, have revolutionized healthcare practices. The introduction of such treatment options has led to a paradigm shift in drug development, production and consumption. Moreover, such therapies have actually enabled healthcare providers to treat several difficult-to-treat clinical conditions.

In the past two decades, more than 30 such therapy products have been approved; recent approvals include Zolgensma (2019), RECELL System (2018), AmnioFix (2018), EpiFix (2018), EpiBurn (2018), Alofisel (2018), LUXTURNA (2017), Yescarta (2017), and Kymriah (2017). Further, according to a report published by The Alliance for Regenerative Medicine in 2019, more than 1,000 clinical trials are being conducted across the globe by over 900 companies.

In 2018, around USD 13 billion was invested in this domain, representing a 73% increase in capital investments in this domain, compared to the previous year. It is worth highlighting that, based on an assessment of the current pipeline of cell therapies and the historical clinical success of such products, it is likely that around 10-20 advanced therapies are approved by the US FDA each year, till 2025.

The commercial success of cell and advanced therapies is not only tied to whether they are capable of offering the desired therapeutic benefits, but also on whether the developers are able to effectively address all supply chain requirements. The advanced therapy medicinal products supply chain is relatively more complex compared to the conventional pharmaceutical supply chain. As a result, there are a number of risks, such as possible operational inefficiencies, capacity scheduling concerns, process delays leading to capital losses, and deliverable tracking-related issues, which need to be taken into consideration by therapy developers.

This has generated a need for bespoke technological solutions, which can be integrated into existing processes to enable the engaged stakeholders to oversee and manage the various aspects of the cell and advanced therapies supply chain, in compliance to global regulatory standards. Over the years, several innovative, software-enabled systems, offering supply chain orchestration and needle-to-needle traceability, have been developed.

The market has also recently witnessed the establishment of numerous partnerships, most of which are agreements between therapy developers and software solutions providers. Further, given the growing demand for cost-effective personalized medicinal products, and a myriad of other benefits of implementing such software solutions, the niche market is poised to grow significantly in the foreseen future.

Amongst other elements, the report features:

In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios portraying the conservative, base and optimistic tracks of the industry's evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

Key Topics Covered

1. PREFACE1.1. Scope of the Report1.2. Research Methodology1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION3.1. Context and Background3.2. An Introduction to Cell and Advanced Therapies3.2.1. Classification of Advanced Therapy Medicinal Products3.2.2. Current Market Landscape3.3. Cell and Advanced Therapies Supply Chain3.3.1. Key Processes3.3.2. Challenges Associated with the Cell and Advanced Therapies Supply Chain3.4. Software Solutions for Cell and Advanced Therapies Supply Chain Management3.4.1. Cell Orchestration Platform3.4.2. Enterprise Manufacturing System3.4.3. Inventory Management System3.4.4. Laboratory Information Management System3.4.5. Logistics Management System3.4.6. Patient Management System3.4.7. Quality Management System3.4.8. Tracking and Tracing System3.5. Growth Drivers and Roadblocks3.6. Emergence of Digital Technologies in Supply Chain Management3.6.1. Blockchain Technology3.6.2. Internet of Things3.6.3. Augmented Reality3.6.4. Big Data Analytics3.6.5. Artificial Intelligence

4. CURRENT MARKET LANDSCAPE4.1. Chapter Overview4.2. Cell and Advanced Therapies Supply Chain Management: Overall Market Landscape4.2.1. Analysis by Type of Software Solution4.2.2. Analysis by Key Specification and Benefit4.3.3. Analysis by Application4.3.4. Analysis by End User4.3.5. Analysis by Mode of Deployment4.3.6. Analysis by Scale of Management4.3.7. Analysis by Regulatory Certifications / Accreditations4.3. Cell and Advanced Therapies Supply Chain Management: Developer Landscape4.2.1. Analysis by Year of Establishment4.2.2. Analysis by Location of Headquarters4.2.3. Analysis by Size of Company4.3.4. Analysis by Support Services Offered4.3.5. Leading Developers: Analysis by Number of Software Solutions

5. COMPANY COMPETITIVENESS ANALYSIS5.1. Chapter Overview5.2. Methodology5.3. Assumptions and Key Parameters5.4. Competitiveness Analysis: Overview of Supply Chain Management Software Solution Providers5.4.1. Small-sized Companies5.4.2. Mid-sized Companies5.4.3. Large Companies

6. CORE SUPPLY CHAIN MANAGEMENT SOFTWARE SOLUTIONS: COMPANY PROFILES6.1. Chapter Overview6.2. Brooks Life Sciences6.2.1. Company Overview6.2.2. Financial Information6.2.3. BiobankPro: Software Description6.2.4. Recent Developments and Future Outlook6.3. Cryoport6.3.1. Company Overview6.3.2. Financial Information6.3.3. Cryoportal: Software Description6.3.4. Recent Developments and Future Outlook6.4. MasterControl6.4.1. Company Overview6.4.2. MasterControl Platform: Software Description6.4.3. Recent Developments and Future Outlook6.5. SAP6.5.1. Company Overview6.5.2. Financial Information6.5.3. SAP S/4HANA: Software Description6.5.4. Recent Development and Future Outlook6.6. Savsu Technologies6.6.1. Company Overview6.6.2. Financial Information6.6.3. evo Cold Chain 2.0: Software Description6.6.4. Recent Development and Future Outlook6.7. TraceLink6.7.1. Company Overview6.7.2. Financial Information6.7.3. Digital Supply Chain Platform: Software Description6.7.4. Recent Developments and Future Outlook

7. CELL ORCHESTRATION PLATFORMS: EMERGING TRENDS AND PROFILES OF KEY PLAYERS7.1. Chapter Overview7.2. Supply Chain Orchestration Platforms7.2.1. Key Functions of Supply Chain Orchestration Platforms7.2.2. Advantages of Supply Chain Orchestration Platforms7.2.3. Supply Chain Orchestration Platform Implementation Strategies7.3. Supply Chain Orchestration Platform: Trends on Twitter7.3.1. Scope and Methodology7.3.2. Historical Trends in Volume of Tweets7.3.3. Popular Keywords7.4. Key Industry Players7.4.1. Be The Match BioTherapies7.4.2. Clarkston Consulting7.4.3. Haemonetics7.4.4. Hypertrust Patient Data Care7.4.5. Lykan Bioscience7.4.6. MAK-SYSTEM7.4.7. sedApta Group7.4.8. Stafa Cellular Therapy7.4.9. Title 21 Health Solutions7.4.10. TrakCel7.4.11. Vineti

8. FUNDING AND INVESTMENT ANALYSIS8.1. Chapter Overview8.2. Types of Funding8.3. Cell and Advanced Therapies Supply Chain Management: Recent Funding Instances8.3.1. Analysis by Number of Funding Instances8.3.2. Analysis by Amount Invested8.3.3. Analysis by Type of Funding8.3.4. Analysis by Number of Funding Instances and Amount Invested across Different Software Solutions8.3.5. Most Active Players: Analysis by Amount Invested8.3.6. Most Active Investors: Analysis by Participation8.3.7. Geographical Analysis by Amount Invested8.4. Concluding Remarks

9. PARTNERSHIPS AND COLLABORATIONS9.1. Chapter Overview9.2. Partnership Models9.3. Cell and Advanced Therapies Supply Chain Management: Recent Collaborations and Partnerships9.3.1. Analysis by Year of Partnership9.3.2. Analysis by Type of Partnership9.3.3. Analysis by Partner's Focus Area9.3.4. Analysis by Type of Software Solution9.3.5. Most Active Players: Analysis by Number of Partnerships9.3.6. Analysis by Regions

10. PLATFORM UTILIZATION USE CASES10.1. Chapter Overview10.2. Cell and Advanced Therapies Supply Chain Management: Recent Platform Utilization Use Cases10.2.1. Analysis by Year of Utilization10.2.2. Analysis by User's Focus Area10.2.3. Analysis by Type of Software Solution10.2.4. Most Active Players: Analysis by Number of Utilization Instances10.2.5. Most Active Players: Regional Analysis by Number of Utilization Instances

11. VALUE CHAIN ANALYSIS11.1. Chapter Overview11.2. Cell and Advanced Therapies Value Chain11.2. Cell and Advanced Therapies Value Chain: Cost Distribution11.3.1. Donor Eligibility Assessment11.3.2. Sample Collection11.3.3. Manufacturing11.3.4. Logistics11.3.5. Patient Verification and Treatment Follow-up

12. STAKEHOLDER NEEDS ANALYSIS12.1. Chapter Overview12.2. Cell and Advanced Therapies Supply Chain Management: Needs of Different Stakeholders12.2.1. Comparison of Stakeholder Needs

13. COST SAVINGS ANALYSIS13.1. Chapter Overview13.2. Key Assumptions and Methodology13.3. Overall Cost Saving Potential of Supply Chain Management Software Solutions, 2019-203013.3.1. Cost Saving Potential in Donor Eligibility Assessment, 2019-203013.3.2. Cost Saving Potential in Sample Collection, 2019-203013.3.3. Cost Saving Potential in Manufacturing, 2019-203013.3.4. Cost Saving Potential in Logistics, 2019-203013.3.5. Cost Saving Potential in Patient Verification and Treatment Follow-up, 2019-2030

14. MARKET FORECAST14.1. Chapter Overview14.2. Key Assumptions and Forecast Methodology14.3. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market, 2019-203014.3.1. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Application14.3.2. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by End User14.3.3. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Type of Software Solution14.3.4. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Mode of Deployment14.3.5. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Geography14.4. Overall Cell and Advanced Therapies Supply Chain Management Solutions Market: Distribution by Application, Type of Software Solution and Mode of Deployment14.4.1. Cell and Advanced Therapies Supply Chain Management Solutions Market for Donor Eligibility Assessment, 2019-203014.4.2. Cell and Advanced Therapies Supply Chain Management Solutions Market for Sample Collection, 2019-203014.4.3. Cell and Advanced Therapies Supply Chain Management Solutions Market for Manufacturing, 2019-203014.4.4. Cell and Advanced Therapies Supply Chain Management Solutions Market for Logistics, 2019-203014.4.5. Cell and Advanced Therapies Supply Chain Management Solutions Market for Patient Verification and Treatment Follow-up, 2019-2030

15. EXECUTIVE INSIGHTS15.1. Chapter Overview15.2. Thermo Fisher Scientific15.2.1. Company Snapshot15.2.2. Interview Transcript: Bryan Poltilove, Vice President and General Manager15.3. Cell and Gene Therapy Catapult15.3.1. Company Snapshot15.3.2. Interview Transcript: Jacqueline Barry, Chief Clinical Officer15.4. McKesson15.4.1. Company Snapshot15.4.2. Interview Transcript: Jill Maddux, Director, Cell and Gene Therapy Product Strategy, and Divya Iyer, Senior Director, Corporate Strategy and Business Development15.5. TrakCel15.5.1. Company Snapshot15.5.2. Interview Transcript: Martin Lamb, Chief Business Officer

16. CONCLUDING REMARKS16.1. Chapter Overview16.2. Key Takeaways

17. APPENDIX 1: LIST OF ADDITIONAL SUPPLY CHAIN MANAGEMENT SOFTWARE SOLUTIONS

18. APPENDIX 2: TABULATED DATA

19. APPENDIX 3: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/kw1hkc

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Cell and Advanced Therapies Supply Chain Management Industry Report, 2019-2030 - GlobeNewswire

The recent report added by Verified Market Research gives a detailed account of the drivers and restraints in the Global Regenerative Medicine market. The research report, titled [Global Regenerative Medicine Market Size and Forecast to 2026] presents a comprehensive take on the overall market. Analysts have carefully evaluated the milestones achieved by the global Regenerative Medicine market and the current trends that are likely to shape its future. Primary and secondary research methodologies have been used to put together an exhaustive report on the subject. Analysts have offered unbiased outlook on the global Regenerative Medicine market to guide clients toward a well-informed business decision.

Global Regenerative Medicine Market was valued at USD 19.10 Billion in 2018 and is expected to witness a growth of 22.72% from 2019-2026 and reach USD 98.10 Billion by 2026.

The comprehensive research report has used Porters five forces analysis and SWOT analysis to give the readers a fair idea of the direction the global Regenerative Medicine market is expected to take. The Porters five forces analysis highlights the intensity of the competitive rivalry while the SWOT analysis focuses on explaining strengths, weaknesses, opportunities, and threats present in the global Regenerative Medicine market. The research report gives an in-depth explanation of the trends and consumer behavior pattern that are likely to govern the evolution of the global Regenerative Medicine market.

The following Companies as the Key Players in the Global Regenerative Medicine Market Research Report:

Regions Covered in the Global Regenerative Medicine Market:

Europe (Germany, Russia, UK, Italy, Turkey, France, etc.)

The Middle East and Africa (GCC Countries and Egypt)

North America (United States, Mexico, and Canada)

South America (Brazil etc.)

Asia-Pacific (China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

The scope of the Report:

The research report on global Regenerative Medicine market includes segmentation on the basis of technology, application, end users, and region. Each segmentation is a chapter, which explains relevant components. The chapters include graphs to explain the year-on-year progress and the segment-specific drivers and restraints. In addition, the report also provides the government outlooks within the regional markets that are impacting the global Regenerative Medicine market.

Lastly, Verified Market Researchs report on Regenerative Medicine market includes a detailed chapter on the company profiles. This chapter studies the key players in the global Regenerative Medicine market. It mentions the key products and services of the companies along with an explanation of the strategic initiatives. An overall analysis of the strategic initiatives of the companies indicates the trends they are likely to follow, their research and development statuses, and their financial outlooks. The report intends to give the readers a comprehensive point of view about the direction the global Regenerative Medicine market is expected to take.

Ask for Discount @https://www.verifiedmarketresearch.com/ask-for-discount/?rid=7157&utm_source=MRS&utm_medium=005

Table of Content

1 Introduction of Regenerative Medicine Market

1.1 Overview of the Market 1.2 Scope of Report 1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research

3.1 Data Mining 3.2 Validation 3.3 Primary Interviews 3.4 List of Data Sources

4 Regenerative Medicine Market Outlook

4.1 Overview 4.2 Market Dynamics 4.2.1 Drivers 4.2.2 Restraints 4.2.3 Opportunities 4.3 Porters Five Force Model 4.4 Value Chain Analysis

5 Regenerative Medicine Market, By Deployment Model

5.1 Overview

6 Regenerative Medicine Market, By Solution

6.1 Overview

7 Regenerative Medicine Market, By Vertical

7.1 Overview

8 Regenerative Medicine Market, By Geography

8.1 Overview 8.2 North America 8.2.1 U.S. 8.2.2 Canada 8.2.3 Mexico 8.3 Europe 8.3.1 Germany 8.3.2 U.K. 8.3.3 France 8.3.4 Rest of Europe 8.4 Asia Pacific 8.4.1 China 8.4.2 Japan 8.4.3 India 8.4.4 Rest of Asia Pacific 8.5 Rest of the World 8.5.1 Latin America 8.5.2 Middle East

9 Regenerative Medicine Market Competitive Landscape

9.1 Overview 9.2 Company Market Ranking 9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview 10.1.2 Financial Performance 10.1.3 Product Outlook 10.1.4 Key Developments

11 Appendix

11.1 Related Research

Request Customization of Report @ https://www.verifiedmarketresearch.com/product/global-regenerative-medicine-market/?utm_source=MRS&utm_medium=005

We also offer customization on reports based on specific client requirement:

1- Free country level analysis for any 5 countries of your choice.

2- Free Competitive analysis of any market players.

3- Free 40 analyst hours to cover any other data points

About Us:

Verified market research partners with clients to provide insight into strategic and growth analytics; data that help achieve business goals and targets. Our core values include trust, integrity, and authenticity for our clients.

Analysts with high expertise in data gathering and governance utilize industry techniques to collate and examine data at all stages. Our analysts are trained to combine modern data collection techniques, superior research methodology, subject expertise and years of collective experience to produce informative and accurate research reports.

Contact Us:

Mr. Edwyne Fernandes Call: +1 (650) 781 4080 Email: [emailprotected]

This post was originally published on Market Research Sheets

See more here:
Regenerative Medicine Market Segmentation, Top Companies, Applications, Comprehensive Research Report and Forecast to 2026 - Market Research Sheets

As a critical care resident from Peru studying at Saint Louis University, the process of a lung transplant caught Dr. Jorge Malleas attention.

It was very interesting to me to see how you could actually change one persons lungs for another persons lungs and then make it work, said Mallea, medical director of Mayo Clinics lung restoration facility.

It was very intense, very labor demanding, intellectually, very challenging, he said.

Mallea went on to complete his fellowship in pulmonary medicine at Saint Louis University in St. Louis, Missouri.

As he was looking for work, a mentor from his residency, Dr. Cesar Keller, recruited him to join the lung transplant team at Mayo Clinic.

Two other doctors he knew from St. Louis already were at Mayo Clinic in Jacksonville, so Mallea joined the hospital in 2003.

In 2015, Mayo Clinic announced it would partner with United Therapeutics to develop a lung restoration center on its Jacksonville campus.

The form of regenerative medicine is designed to take donor lungs thatpreviously would have been unusable and turn them into viable transplant organs.

The center is on the first floor of the new Discovery and Innovation building on Mayo Clinics campus.

In August, Mallea became medical director of the facility. He believes the technology can change the way lung transplants are done.

The ex-vivo lung perfusion technology, which is used in the facility, allows for the lung restoration team to spend more time with donor lungs, which would help make more lungs available for transplant.

Mallea said the technology can make the lungs treated in the Jacksonville facility better than the standard lung, and last longer than the typical lung transplant.

He wants to save the nearly 400 people who die annually waiting for a lung transplant.

The goal is to chop that number from 400 to zero, Mallea said.

So far, only trials have been completed in the Mayo Clinic facility, which opened in August. When it receives FDA approval, which likely will be in January, the facility will have the capacity to treat nearly 900 lungs each year.

Aside from serving as medical director of the facility, Mallea works as a pulmonologist, seeing patients suffering from COPD or emphysema on campus.

He said those patients, given the nature of their disease and chance of mortality within the next year, often are low on the list to receive a transplant.

Part of his work at Mayo Clinic is trying to find solutions for those patients. Hes working on developing a trial to treat COPD patients with mesenchymal stem cells, but its in the early stages, he said.

Mallea said he and the United Therapeutics team also hope to be able to regenerate lungs using biomaterials or stem cells in the future, which would create more ways to increase the lung donor pool.

Sometimes its looking into the future and it looks like science fiction, Mallea said. But it really is exciting, the things that we can do, or the things that were hoping to do soon.

Working on the lung transplant and now lung restoration teams has been rewarding, Mallea said. Hes seen lung restoration in action at United Therapeutics Silver Spring, Maryland, facility, which performs the procedures.

Sometimes lungs will come into the facility, and its unclear if they will work for a transplant. After inspection and by tweaking a few things, those lungs can then be suitable, he said.

You can see the difference that having them in the facility can make, he said. So thats definitely a satisfaction of being part of that team, being able to know that another persons getting a second chance of life because theyre receiving lungs that are going to save their lives.

Mallea considers himself lucky to be in a situation where I can be part of developing, discovering and hopefully transforming the future with a great team.

See more here:
Doctors goal: End the wait for lung transplants - Jacksonville Daily Record

Brian Wedding

Boca Raton, FL The Florida Atlantic University Athletic Department has partnered with Brian Wedding and RoofClaim.com on a $5 million, 10-year sponsorship to name the RoofClaim.com Arena, home of the FAU mens and womens basketball and volleyball teams.

We are tremendously excited to partner with Brian Wedding and RoofClaim.com, saidBrian White,vice president and director of athletics. This partnership is transformational for our student-athletes and fans, as well as the community. We are thrilled about the opportunities provided to FAU and our athletics department from this investment.

Wedding is the founder/CEO of RoofClaim.com, a company he has aligned with several reputable and charitable companies and organizations though corporate partnerships. RoofClaim.com is a technology service company specializing in the diagnosing and processing of shingle and tile roof replacement insurance claims though the use of cutting-edge technology, and industry leading processes. The company is recognized nationally for its services and is also a member of the National Roofing Contractors Association and the National Association of Home Builders. RoofClaim.com is a subsidiary ofJasper Inc.

I am very excited about the growth and vision of Florida Atlantic University, under the direction of President Kelly and Director of Athletics Brian White, said Wedding. There is a lot of synergy between FAU and RoofClaim.com. We are both working to help those in the South Florida region, as well as expand the student and fan experience. I look forward to raising a championship trophy with FAU one day.

Florida Atlantic University Athletics:

FAU Athletics is comprised of 21 intercollegiate teams involving 450 student athletes that compete in baseball, basketball, cross country,football, golf, soccer, softball, swimming and diving, tennis, indoor and outdoor track, volleyball, beach volleyball, cheer and dance. The Owls are a NCAA Division I-A (FBS) institution and compete in Conference USA and the Coastal Collegiate Sports Association (CCSA) (Beach Volleyball, Mens Swimming). The Owls have been playing football since 2001 and have captured two bowl games. The dance team finished its 2014 season No. 8, nationally. FAU Cheer won a national championship in 2016.

About Florida Atlantic University:

Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University, with an annual economic impact of $6.3 billion, serves more than 30,000 undergraduate and graduate students at sites throughout its six county service region in southeast Florida. FAUs world-class teaching and research faculty serves students through 10 colleges: the Dorothy F. Schmidt College of Arts and Letters, the College of Business, the College for Design and Social Inquiry, the College of Education, the College of Engineering and Computer Science, the Graduate College, the Harriet L. Wilkes Honors College, the Charles E. Schmidt College of Medicine, the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan: Healthy aging, biotech, coastal and marine issues, neuroscience, regenerative medicine, informatics, lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAUs existing strengths in research and scholarship. For more information, visitfau.edu.

Arena

Link:
FAU Athletics Receives $5 Million Sponsorship from Roof Claim to Name FAU Arena - The Boca Raton Tribune

WASHINGTON, Dec. 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization for the cell and gene therapy and broader regenerative medicine sector, today released the initial slate of presenting companies at the 2020 Cell & Gene Meeting on the Mediterranean. The event will be held April 15-17, 2020 in Barcelona, Spain.

The event, modeled after ARMs highly successful Cell & Gene Meeting on the Mesa, is expected to attract more than 500 attendees, including senior executives from leading cell therapy, gene therapy, and tissue engineering companies worldwide, large pharma and biotech representatives, institutional investors, academic research institutions, patient foundations, disease philanthropies, and members of the life science media community.

The second annual Cell & Gene Meeting on the Mediterranean will feature presentations by 50+ leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies.

The initial slate of 2020 presenting companies includes: Adaptimmune, AGTC, Ambys Medicines, American Gene Technologies, AskBio, Aspect Biosystems, Atara, Autolus Therapeutics, Avectas, AVROBIO, Axovant Gene Therapies, bluebird bio, Bone Therapeutics, Caribou Biosciences, Celavie Biosciences, Cellatoz Therapeutics, CEVEC, Cynata Therapeutics, Flexion Therapeutics, Fraunhofer IZI, GenSight Biologics, Healios, Iovance Biotherapeutics, Kiadis Pharma, Kytopen, LogicBio Therapeutics, MeiraGTx, Minerva Biotechnologies, MolMed, Novadip Biosciences, Orchard Therapeutics, Oxford Biomedica, PDC*line Pharma, Precision BioSciences, Promethera Biosciences, PTC Therapeutics, Recombinetics, REGENXBIO, ReNeuron, Rexgenero, Sangamo, SmartPharm Therapeutics, Standards Coordinating Body for Regenerative Medicine, Theradaptive, ThermoGenesis, Tmunity Therapeutics, Ultragenyx Pharmaceutical, VERIGRAFT, and Zelluna Immunotherapy.

Additional event details will be updated regularly on the conference website http://www.meetingonthemed.com.

Registration is complimentary for investors and credentialed members of the media. To learn more and to register, please visitwww.meetingonthemed.com. For members of the media interested in attending, please contact Kaitlyn Donaldson Dupont at kdonaldson@alliancerm.org.

For interested organizations looking to increase exposure to this fields top decision-makers via sponsorship, please contact Kelly McWhinney at kmcwhinney@alliancerm.org for additional information.

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.

Original post:
The Alliance for Regenerative Medicine Releases Initial Slate of Presenting Companies at the 2020 Cell & Gene Meeting on the Mediterranean - Yahoo...

December 19, 2019 - SACRAMENTO, CA- Secretary of State Alex Padilla announced that the proponent of a new initiative was cleared to begin collecting petition signatures.

The Attorney General prepares the legal title and summary that is required to appear on initiative petitions. When the official language is complete, the Attorney General forwards it to the proponent and to the Secretary of State, and the initiative may be circulated for signatures. The Secretary of State then provides calendar deadlines to the proponent and to county elections officials. The Attorney Generals official title and summary for the measure is as follows:

AUTHORIZES BONDS TO CONTINUE FUNDING STEM CELL AND OTHER MEDICAL RESEARCH. INITIATIVE STATUTE.Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: (1) stem cell and other medical research, therapy development, and therapy delivery; (2) medical training; and (3) construction of research facilities. Dedicates $1.5 billion to fund research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions. Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years. Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local governments:State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds.(19-0022A1.)

The Secretary of States tracking number for this measure is 1880 and the Attorney General's tracking number is 19-0022.

The proponent of the measure, Robert N. Klein, must collect signatures of 623,212 registered voters (five percent of the total votes cast for Governor in the November 2018 general election) in order to qualify it for the ballot. The proponent has 180 days to circulate petitions for the measure, meaning the signatures must be submitted to county elections officials no later than June 15, 2020*. The proponent can be reached c/o James C. Harrison of Remcho, Johansen & Purcell, LLP at (510) 346-6203. The address for Remcho, Johansen & Purcell, LLP is 1901 Harrison Street, Suite 1550, Oakland, CA 94612.

*Date adjusted for official deadline, which falls on a Sunday (Elec. Code 15)Source: CA. SOS

Read this article:
California Proposed Initiative Enters Circulation: Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research - Sierra Sun Times

SmartTRAK recently redesigned SmartTRAK.com to prioritize key information for various functional groups as their customer base continues to expand

BioMedGPS, the developer of SmartTRAK Business Intelligence, is excited to announce the launch of their new website, Smarttrak.com. SmartTRAK offers a suite of advisory services for the life sciences industry including real-time online business intelligence and custom consulting.

The new SmartTRAK.com features a clean uncluttered design, improved functionality and enhanced custom content. It allows for medical device professionals to self-identify and learn how SmartTRAKs services, data, and industry insights help meet their specific professional needs. Visitors can learn how SmartTRAK can help streamline their workflow, saving them time while keeping them ahead of the market.

Marketing Technology News: Users Reveal Top Five SMM Vendors of 2019 for User Satisfaction Through SoftwareReviews

The newly launched site also spotlights our industry analysts all who are experts in their fields with years experience working for some of the biggest players in the industry. Visitors can sample articles, analyses and white papers put out by SmartTRAKs team.

Users can also view SmartTRAKs offering by market coverage including orthopedics, wound care, regenerative medicine and neuro therapies. Visitors can quickly pinpoint what coverage they would need and also quickly assess any future needs.

Marketing Technology News: MindTouch Enhances Salesforce Integration for an Improved Customer and Agent Experience

The new site, content and improved functionality speak directly to the needs of our customers. We believe that this new website will allow our visitors to have a very informative experience as we continue to grow, states Sharon OReilly, CEO, and President of BioMedGPS.

Medical device manufacturers who have business intelligence needs are encouraged to reach out to SmartTRAK to learn how SmartTRAK can support their teams.

Marketing Technology News: Ameriprise Financials New Customer Relationship Management System Helps Advisors Deliver Best-in-Class Service

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SmartTRAK Launches New Website that Speaks Directly to Customer Needs - MarTech Series

It has long been understood, and by cultures too various to list, that salamanders have something of the supernatural about them.

Their name is thought to derive from an ancient Persian vocable meaning 'fire within', and for at least 2,000 years they were believed to be impervious to flames, or even capable of extinguishing them on contact. Aristotle recorded this exceptional characteristic, as did Leonardo da Vinci. The Talmud advises that smearing salamander blood on your skin will confer inflammability. Not so. But the intuition that salamanders possess fantastical powers is not unfounded.

Like earthbound immortals, salamanders regenerate. If you cut off a salamander's tail, or its arm, or its leg, or portions of any of these, it will not form a stump or a scar but will instead replace the lost appendage with a perfect new one, an intricacy of muscle, nerve, bone and the rest. It will sprout like a sapling. Science has been chopping up salamanders for more than 200 years with the aim of simply understanding the mechanics of their marvels, but more recently with the additional aim of someday replicating those marvels in ourselves. Might salamanders be the great hope of regenerative medicine?

The salamander in which regeneration is most often studied is an odd and endearingly unattractive Mexican species known as the axolotl. In addition to its limbs and extremities, the axolotl is known to regrow its lower jaw, its retinae, ovaries, kidneys, heart, rudimentary lungs, spinal cord, and large chunks of its brain. It heals all sorts of wounds without scarring. The axolotl also integrates the body parts of its fellows as if they were its own, without the usual immune response, and this peculiar trait has facilitated some of the more grotesque disfigurements it's endured in the name of science. In experiments after the Second World War, East German scientists grafted small axolotls crosswise through the backs of larger ones. The animals' circulatory systems came to be linked, and the researchers hailed the conjoined mutants as triumphs of collectivism. While the axolotl can rebound from almost any bodily humiliation, it seems that humankind is proving too much for it: we have all but destroyed its natural habitat, and, outside of laboratory aquaria, it is nearly extinct.

In its most common form, which scientists call the white mutant, the axolotl resembles what the translucid foetus of a cross between an otter and a shortfin eel might look like. On the internet, it is celebrated for its anthropoid smile; in Mexico, where the Aztecs once hailed as it as a godly incarnation, it is an insult to say that someone looks like one. Behind its blunt and flattened head extends a distended torso resolving into a long, ichthyic tail. The axolotl can grow to nearly a foot in length; four tiny legs dangle off its body like evolutionary afterthoughts. It wears a collar of what seem to be red feathers behind each cheek, and these ciliated gill stalks float and tremble and gently splay in the water, like the plumage in a burlesque fan. They grow back if you cut them off, too. Precisely how the animal accomplishes this, or any of its feats of regrowth, is not well understood.

Like the axolotl, our evolutionary forebears seem to have been regenerators, and human children can in fact still regrow the tips of their fingers above the final joint, but that's the only complex regeneration we're known to do. We are, instead, a species that scars. Why our lineage lost its regenerative birthright is unclear. From our present evolutionary vantage point, however, it might be nice to get back what we lost. Amputees could recover their limbs; paralytics could walk; degeneration and decline of all sorts might be reversed.

Last year, after a long effort by an international consortium, the axolotl genome 10 times the length of the human genome was finally sequenced. In early 2019, it was mapped onto chromosomes by a team at the University of Kentucky. (It is, for the moment, the longest genome ever sequenced by far.) Jessica Whited, who heads an axolotl lab at Harvard Medical School, told me that, for those who hope to someday make regeneration available to human medicine, the axolotl is a perfect instruction manual. Its language simply needs decoding.

Regeneration is not, however, the axolotl's only biological extravagance, or prime mystery. Another puzzle of the axolotl concerned what it was. Most salamanders begin their lives as aquatic larvae, like tadpoles, before metamorphosing into terrestrial adults, but the axolotl seems to be a lifelong adolescent, the so-called 'Peter Pan of salamanders', remaining in its larval stage even as it arrives at sexual maturity. This retention of juvenile traits, a phenomenon known as neoteny, perplexed taxonomists, and for decades they debated whether it ought to be considered a species of its own or merely the larval form of the common tiger salamander. Confoundingly, on occasion the axolotl could be goaded (under what conditions remains unclear) into a final transformation, absorbing its gills and fins, and walking out of the water. In biological terms, the scale of this change is akin to a middle-aged human one day broadening her shoulders, lurching forward on her hands and loping off to the jungle to be a gorilla. In France, the Grand Dictionnaire Universel du XIXe sicle (1866) declared the axolotl 'the most imperfect, the most degraded of all the amphibians': a fallen creature, but also one that could accede, as if by grace, to a higher state of being.

Humans are attuned to this sort of qualified possibility. In 1920, the British biologist Julian Huxley found that he could cause axolotls to metamorphose by feeding them bits of sheep thyroid. The Daily Mail declared that Huxley had discovered 'The Elixir of Life'. Huxley's younger brother, the writer Aldous, adopted the axolotl as a metaphor for mankind, its peculiar neoteny an emblem of our incompletion, our frustrated potentiality. A number of his literary contemporaries became neoteny-boosters. Gerald Heard, the philosophising scholar, maintained in 1941 that the survival of mankind would depend upon individuals 'who manage to retain, with full mental stature, the radical originality and freshness of a vigorous child'; John Dewey and Timothy Leary held similar views. More recently, the Mexican sociologist Roger Bartra has proposed the axolotl, in its neotenous indeterminacy, as a symbol of his country's national character.

If the axolotl mirrors us so nicely, it's fitting that we, too, are neotenous. Our flat faces, small noses, hairless bodies and upright postures are all features of infancy in our evolutionary cousins and forebears. We also spend more of our lives in a juvenile state than any other primate. Our brains grow rapidly for a longer period, and are consequently larger; our childhoods are greatly extended, providing occasion for the lengthy training of those brains. We also maintain throughout our lives a 'remarkable persistent juvenile characteristic of investigative curiosity', in the words of the zoologist Konrad Lorenz. 'The constitutive character of man,' Lorenz wrote in 1971, 'is a neotenous phenomenon.'

Some affinity seems to have drawn us to the salamander since well before we fantasised in a serious way of regrowing our bodies how the salamander regrows its own. Perhaps this is what spurred the ancients and the Aztecs to ennoble the animals through mythology. Nowhere has the intuition of kinship been rendered more plainly, though, than in the Argentinian surrealist Julio Cortzar's short story 'Axolotl' (1952). Cortzar writes of one man's quiet obsession with the animals, whom he visits every day at an aquarium. 'After the first minute I knew that we were linked,' the man says, 'that something infinitely lost and distant kept pulling us together.' He watches through the glass tank until, one day, almost imperceptibly, he finds himself suspended in the water beside the creatures, transmuted into one of them, peering out at his former human soma peering in. 'Only one thing was strange: to go on thinking as usual,' the erstwhile man says, 'to know.'

This article was originally published at Aeon and has been republished under Creative Commons. Read the original article.

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Can the axolotl teach us to regenerate? - Big Think

NEWPORT NEWS, Va.,Dec. 18, 2019/PRNewswire/ Orthopaedic and Spine Center announced Dr.Jeffrey Carlson, Orthopaedic Spine Surgeon, became the first surgeon in Central andEastern Virginiaarea to implant the M6-Cartificial cervical disc. The outpatient surgery was performed on a 53 year old female at Bon Secours/Mercy Health Mary Immaculate Hospital inNewport News, VirginiaonNovember 20, 2019.

The patient reported symptoms of severe neck pain which radiated to both shoulders after a motor vehicle accident. After she failed to respond to conservative treatment, an MRI was ordered revealing severe spinal stenosis and spinal cord abutment at level C3-4 caused by a herniated disc. In consultation with Dr. Carlson, the patient made the decision to have cervical disc arthroplasty, using the Orthofix M6-C artificial cervical disc.

Ive been waiting for the right patient with the appropriate diagnosis to employ the M6-C disc, said Carlson. The technology used in this procedure facilitates a speedy recovery with minimal limitations and a great outcome, so that my patient can get back to her active life. She just had her two week post-surgical follow-up appointment her recovery is going very well and she feels much relief from the severe pain she once experienced.

The M6-C disc received U.S. Food and Drug Approval in February 2019.It was designed to closely mimic the anatomic structure of a natural disc as well as provide an effective alternative to a spinal fusion. By allowing the spine to move naturally, the M6-C artificial disc potentially minimizes stress to adjacent discs and other vertebral structures.

AboutJeffrey R. Carlson, M.D.Dr.Jeffrey Carlsonhas been a part of Orthopaedic & Spine Center since 1999 and serves as the President and Managing Partner. He is a board-certified, fellowship-trained orthopaedic surgeon who focuses on the treatment of injuries and disorders of the spine.

About Orthopaedic & Spine CenterOrthopaedic & Spine Center (OSC) is staffed by outstanding medical professionals who strive to provide the very best orthopaedic and interventional pain management care available anywhere. Our Center includes a comfortable, state-of-the-art medical facility, pleasant and well-trained personnel, physicians trained in the most advanced orthopaedic treatments, interventional pain management procedures, regenerative medicine, using stem cell and platelet therapies and a dedication to old-fashioned patient care.

SOURCE Orthopaedic & Spine Center

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Orthopaedic Surgeon, Dr. Jeffrey Carlson, first in Central and Eastern Virginia to implant the M6-C Artificial Cervical Disc - OrthoSpineNews

WASHINGTON, D.C., Dec. 11, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, announced its 2020 Cell & Gene Therapies State of the Industry briefing will take place January 13, 2020 in San Francisco, held in conjunction with Biotech Showcase 2020.

ARMs State of the Industry briefing is the largest cell and gene therapy-focused annual event taking place during the week of the 2020 J.P. Morgan Healthcare Conference. The briefing is expected to attract more than 500 of the fields leading executives, investors, life science media, patient advocates, and academic leaders.

This briefing offers a comprehensive industry overview, including insights into key sector trends and metrics, the financial and partnering outlook, recent advances, the clinical pipeline and potential product approvals, commercialization challenges, and a preview of the coming year.

Preliminary Agenda:

8:00 8:20am | Introduction & Industry UpdateJanet Lambert,CEO, Alliance for Regenerative Medicine

8:20am 9:05am | Emerging Cell Therapies for CancerPascal Touchon,CEO, Atara BiotherapeuticsMatthew Kane,Co-Founder and CEO, Precision BioSciencesSamarth Kulkarni,CEO, CRISPR Therapeutics

9:05am 9:50am | Next Generation Gene and Cell TechnologiesShelia Mikhail,CEO, AskBioLaurence Cooper,CEO, ZiopharmTimothy Miller,Co-Founder, President, & Chief Scientific Officer, Abeona Therapeutics

Registration is complimentary and open to the public; however,RSVP is required. The event will be broadcast live via streaming webcast,available on ARMs website.

The briefing will take place at the Parc 55 Hilton, 55 Cyril Magnin Street in San Francisco, California from 8:00 9:50am and is held in conjunction with Biotech Showcase, organized by EBD Group and Demy Colton. Please note that attendance at this briefing is separate from registering to attend the Biotech Showcase conference, which requires paid registration.

About The Alliance for Regenerative MedicineThe 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.

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The Alliance for Regenerative Medicine Announces 2020 Cell & Gene Therapies State of the Industry Briefing - GlobeNewswire

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.

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