Category Archives: Regenerative Medicine

WASHINGTON, Dec. 13, 2012 /PRNewswire/ -- The Alliance for Regenerative Medicine (ARM) today announced the formation of a Tissue Engineering and Biomaterials Committee (TEBC). The TEBC has been established to assemble the companies, academic institutions, and organizations within the Alliance for Regenerative Medicine that develop and commercialize tissue engineered and biomaterial based technologies. The primary purpose of the TEBC is to develop a better understanding of the key barriers to translation and scale up of regenerative medicine technologies including challenges in efficient product design, pilot and scale up manufacturing, regulation, and reimbursement. In addition the TEBC will focus on building public awareness of this new field of medicine and an appreciation for its potential to transform healthcare.

Members of the TEBC will include private and public sector representatives involved in the field of tissue engineering. Tissue engineered technologies are being developed as clinical therapeutics to improve biological functions primarily through the repair, restoration, or total replacement of tissue or organ and are also being developed and commercialized as 3D tissue models and micro-organs to provide better research tools for drug discovery and clinical diagnostics. The TEBC group will include experts from interdisciplinary technologies that utilize cells, biomaterials, growth factors, small molecules, scaffolds, and other therapeutic agents to affect tissue growth or regeneration. The Committee will be led by Sarah Haecker PhD, a member of ARM's senior staff. Sarah has more than 20 years of experience in the industry and for the last seven years has specialized in working with companies in the tissue engineering sector.

"We will work to identify and capitalize on opportunities that accelerate product development and commercialization of these innovative regenerative medicine technologies," said Sarah Haecker. "The primary purpose of the TEBC is to determine the unique requirements which will, ultimately, advance and broaden the use of clinical tissue engineered paradigms world-wide."

"To successfully design, develop, and commercialize complex tissue engineered products, it is critical to bring together the leading experts in a multitude of disciplines and technology areas," said Robert Palay, co-chair of the TEBC and Chief Executive Officer of Cellular Dynamics International, Inc. "I am excited to be working with this group which is strategically designed and uniquely qualified to best move the wide range of tissue engineered products forward."

"Tissue engineering has tremendous potential to treat patients suffering from the loss of tissues and organs," said Jennifer H. Elisseeff, co-chair of the TEBC and Professor, Wilmer Eye Institute and Department of Biomedical Engineering, Johns Hopkins University. "We have the ability to establish the critical early and robust communication between the product designers and clinicians to support the successful path through commercialization of these complex products."

"Through the work of the TEBC, we hope to bring tissue engineered therapeutics to patients worldwide more quickly," said Michael Abecassis, MD, co-chair of the TEBC and Founding Director, Northwestern University Comprehensive Transplant Center. "We intend to develop a better understanding amongst key stakeholders as to the requirements to develop a more predictable regulatory pathway and a rational reimbursement framework for tissue engineered and biomaterial based products."

Members of the Tissue Engineering and Biomaterials Committee:

Cellular Dynamics, Circle Biologics, Harvard Bioscience, Histogenics, InVivo Therapeutics, ISTO, JDRF, Johns Hopkins University, McGowan Institute for Regenerative Medicine, MiMedx, Nanofiber Solutions, Northwestern University Comprehensive Transplant Center, Northwestern University's Feinberg School of Medicine, New York Stem Cell Institute, Organogenesis, Organovo, Pfizer, Sanofi Genzyme, Shire Regenerative Medicine, Tengion, Texas Heart Institute, Wake Forest Institute for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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The Alliance for Regenerative Medicine forms Tissue Engineering and Biomaterials Committee

I welcome comments and feedback. 


1. In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) we must do more to help patients distinguish between non-compliant cell therapy treatments (and providers) which are more or less risky. 


2. Whatever we do in response to this issue should be done with an eye to being practical and helpful to patients in the real-life context of their decision about whether or not to buy a non-complaint cell therapy.


3. Our response to this issue should be based on a risk-based approach recognizing that not all non-compliance is created equal.  We should create a framework for risk-based analysis (both for us and our audiences) and focus initiatives around those which present the highest risk.


4. We recognize the problem of non-compliant cell therapies is not just a problem that exists in jurisdictions with little, no, or poor regulation but that is a growing problem even in the most highly regulated jurisdictions meaning the solution cannot be regulated it depends on education and enforcement.


5. We recognize regulatory agencies cannot enforce non-compliance on their own.  We as an industry need to complement their efforts through our own standards and enforcement.


6. Stakeholder groups should support the formation of a multi-organizational  initiative to, based on a risk-based assessment, spotlight the categories or signs of highest-risk offenders for use by patients and/or their physicians in identifying  whether or not treatments (and providers) they may be considering fall into the that category associated with the highest level of risk.

What do you think?

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NEW YORK, Dec. 11, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Regenerative Medicine Industry http://www.reportlinker.com/p090567/Global-Regenerative-Medicine-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Blood_Supply,_Tissue_Banking_and_Transplantation

This report analyzes the worldwide markets for Regenerative Medicine in US$ million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. A six-year historic analysis is also provided for these markets. The report profiles 93 companies including many key and niche players such as BioVest International, Inc., Curis, Inc., Cytori Therapeutics, Inc., Evotec AG, Forticell Bioscience, Inc., Geron Corporation, Integra LifeSciences Corporation, LifeCell Corporation, Osiris Therapeutics, Inc., Tengion, Inc., Tepha Inc., and TiGenix N.V. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations I-1 Disclaimers I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1 A Primer II-1 Current and Future Analysis II-1 Current Global Market for Regenerative Medicine II-2 Therapeutic Companies and Products in Regenerative Medicine - Current Status II-2 Select Therapeutic Regenerative Medicine Products in the Global Market II-3 Market Potential II-3

2. REGENERATIVE MEDICINE IN BONE AND JOINT APPLICATIONS II-5 An Overview of Regenerative Medicine in Bone and Joint Applications II-5 Bone Graft Substitutes - Penetration in Foot and Ankle Surgeries II-5 Repair of Non-Healing Bones - High Market Potential II-5 Market Potential of Bone Graft Substitutes (BGSs) II-6 Table 1: Global Bone Graft Substitute Market (2010): Percentage Share Breakdown of Sales for DePuy, OrthoVita, ApaTech/Baxter, Wright Medical, Medtronic/RTI, Biomet, and Others (includes corresponding Graph/Chart) II-6 Synthetic Bone Graft Substitutes to Replace Traditional Autografts and Allografts II-6 Select Synthetic Products in Orthobiologics II-7 Bone Morphogenic Proteins (BMPs) Gaining Popularity II-7 Bone Morphogenic Protein products in Orthobiology II-7 Table 2: Global Bone Morphogenic Protein Market (2010): Percentage Share Breakdown of Sales for Medtronic/RTI, and Stryker (includes corresponding Graph/Chart) II-7 Demineralized Bone Matrices (DBMs) Market Getting Crowded II-8 Table 3: Global Demineralized Bone Matrix Market (2011): Percentage Share Breakdown of Value Sales for Medtronic/RTI, Synthes/MTF, Integra LifeSciences, Altiva, Bacterin, and Others (includes corresponding Graph/Chart) II-8 Select DBM products in Orthobiologics market II-8 Biomaterials Market - Promising Opportunities for Cost- Effective Products II-8 Existing Bone Graft Procedures - Limitations and Concerns II-9 Autograft Procedures II-9 Allograft - DBM and Other Allografts II-9 BMPs and Other Synthetic Growth Factors II-9 Medical Devices and Implants for Orthopedics II-10 Expanding Opportunities in Hip and Knee Market II-10 Extremity Reconstruction - A Growing Market II-10 Tissue Engineered Cartilage Market - An Overview II-11 Tissue Engineered Cartilages - A Promising Solution for Cartilage Repair II-11 Market Potential of Tissue Engineered Cartilage Products II-11 Potential Applications of Tissue Engineered Cartilage Products II-11 Commercially Available tissue engineered cartilage products II-12 Challenges in Clinical Application of Tissue Engineered Cartilage Products II-13 Bone Marrow Transplants (BMTs) II-13 Market Potential for BMTs II-14 Companies Engaged in CBSC Research for BMTs II-14 Table 4: Global Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales for Medtronic/RTI, Synthes/MTF, DePuy, Osteotech, Orthofix, and Others (includes corresponding Graph/Chart) II-14

Table 5: Global Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales by Product Type for Growth Factors, Synthetics, DMBs, Allografts, and Stem Cells (includes corresponding Graph/Chart) II-15

Table 6: Global Machined Bone and Allograft Market (2010): Percentage Share Breakdown of Value Sales for Synthes/MTF, DePuy, Medtronic/RTI, Osteotech, RTIX, and Others (includes corresponding Graph/Chart) II-15

Table 7: Global Stem Cell Orthobiologics Market (2010): Percentage Share Breakdown of Value Sales for Nuvasive, and Otrhofix includes corresponding Graph/Chart) II-15

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Global Regenerative Medicine Industry

Regenerative Medicine Center, Reviva Lebanon.
Our mission is to bring scientific innovation to patients seeking a trace of hope in new medicine therapy through cellular enhancement and medical excellence. We aim to be recognized as an all-in-one leader center in stem cell and regenerative medicine research and applications in the MENA region.From:revivamedicalViews:0 0ratingsTime:05:59More inPeople Blogs

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Regenerative Medicine Center, Reviva Lebanon. - Video

SUNRISE, FL--(Marketwire - Dec 10, 2012) - Bioheart Inc. ( OTCQB : BHRT ) previouslyannounced that it is working with NorthStar Biotech to help promote regenerative medicine.NorthStar has announced that it will subsidize physicians to participate in the Ageless Regenerative Institute stem cell training program.The fully accredited CME training program includes a didactic lecture series followed by hands-on clinical training for physicians to learn to isolate stem cells for immediate use in their patients.The Ageless Regenerative Institute has successfully trained over 200 physicians and these physicians are utilizing both adipose and bone marrow derived stem cells as well as platelet rich plasma for orthopedics, aesthetics and other degenerative diseases.

With the new NorthStar/Bioheart program, this select group of physicians have the opportunity to receive full funding for the training and join a network of physicians who will offer in-clinic stem cell therapies.Once these physicians commence IRB-approved in-clinic services, Bioheart will receive royalties for the use of these fee-for-service procedures.Initial projections have not been announced by NorthStar.

"Physicians have for years evaluated and considered stem cell treatments as a potential alternative for a subset of our patient population.This program helps educate doctors and allows us a viable opportunity to expand our treatment portfolio for patients in need," said board-certified Miami internist Dr. Antonio Blanco.

Bioheart's president and CEO Mike Tomas said, "The training programs at the Ageless Regenerative Institute provide physicians with extraordinary regenerative medicine capabilities.We are fortunate to partner with Northstar to bring these therapies to the clinic."

Physicians interested in applying to participate in the program should contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research.ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more.ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy.For more information about regenerative medicine please visit http://www.agelessregen.com.

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Bioheart in Partnership With NorthStar on Physician Training in Stem Cell Techniques

Shawn Chavez, PhD, talks about research on selecting healthy embryos for IVF
During in-vitro fertilization (IVF), physicians much choose among many embryos to pick the ones that are most likely to produce a successful pregnancy and health child. Shawn Chavez, PhD, a researcher at the Stanford Institute for Stem Cell Biology and Regenerative Medicine, talks about an automated time-lapse recording system that can accurately detect which embryos are healthiest. She discusses new research showing that a parameter called "fragmentation" is important.From:institutesofmedicineViews:3 0ratingsTime:02:05More inEducation

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Shawn Chavez, PhD, talks about research on selecting healthy embryos for IVF - Video

Live Cell Therapy | Stem Cell Malaysia
stemcellmalaysia.com Live cell therapy is one form of stem cell therapy under the hierarchy of cell therapy, which is under regenerative medicine. Live cell therapy was made popular since 1931 by Dr Paul Niehans, who pioneered the therapy using injection. Oral or injection live cell therapy is far more superior than surgical implantation due to several advantages. Today, live cell therapy has been applied to disease treatment, beauty and health rejuvenation. For more information on stem cell therapy, please visit Stem Cell Malaysia at stemcellmalaysia.comFrom:stemcells2012Views:0 0ratingsTime:12:14More inScience Technology

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Live Cell Therapy | Stem Cell Malaysia - Video

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/6kl7tg/stem_cell_and) has announced the addition of the "Stem Cell & Regenerative Medicine" book to their offering.

The potential use of stem cells in transplantation for the purpose of tissue regeneration is an exciting area of research currently undergoing rapid development. Implantation of human embryonic or autologous, ex vivo-expanded adult stem cells, particularly in older individuals, could circumvent the limited availability of organs/tissues as well as prevent complications related to immune rejection and disease transmission. Musculoskeletal tissue degeneration is closely associated with aging. Strategies employing autologous adult MSCs from older individuals for transplantation in order to regenerate their own ailing organ or tissues require that we vigorously define MSCs capacity to maintain growth potential and differentiation potential into the desirable cell lineages. We are currently restricted by the limited knowledge about physical parameters, such as biomechanical forces, that influence MSC growth and differentiation capacities. This is particularly important for MSCs isolated from older individuals, for whom little information is available.

This special volume aims to serve as an impetus in generating more interest among stem cell researchers and biotechnologists to improve and develop the cell-based therapies of damaged tissue using stem cells.

Topics Covered:

Foreword

Preface

Contributors

CHAPTERS

1 Justice and Vulnerability in Human Embryonic Stem Cell Research

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Research and Markets: Stem Cell & Regenerative Medicine

The World Stem Cell Summit - Dr. Yaszemski
The World Stem Cell Summit, December 3-5 in West Palm Beach, Fla. unites internationally renowned scientists, clinicians, students, policymakers, regulators, patient advocates, and philanthropists to share knowledge and advance collaborations in the stem cell and regenerative medicine community. The meeting includes in-depth programming and more than 150 renowned international speakers, including leaders from Mayo Clinic #39;s Center for Regenerative Medicine. Among them is Mayo Clinic Dr. Michael Yaszemski. In this video he talks about the summit, the emerging field of regenerative medicine and his unique military perspective.From:mayoclinicViews:5 1ratingsTime:04:16More inScience Technology

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The World Stem Cell Summit - Dr. Yaszemski - Video