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Regenerative Medicine Markets

Description:
Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands. Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine.

This TriMark Publications report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures.

The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.
 
Contents:
1. Overview
1.1 Statement of Report
1.2 Scope of this Report
1.3 Methodology
1.4 Executive Summary

2. Regenerative Medicines: An Overview of Segments
2.1 Tissue Engineering
2.1.1 Tissue-Engineered Skin
2.1.2 Tissue-Engineered Cartilage
2.1.3 Tissue-Engineered Bone
2.1.4 Tissue-Engineered Peripheral Nerves
2.1.5 Tissue-Engineered Cornea
2.1.6 Tissue-Engineered Blood Vessels
2.1.7 Progress and Promises for Tissue Engineering Industry
2.1.7.1 Key Positioning Strategies in Tissue Engineering Industry
2.1.7.2 Tissue Engineering Industry Participants
2.1.7.3 Tissue Engineering Firms by their Product Applications
2.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products
2.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products
2.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products
2.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney
2.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products
2.1.7.9 Tissue Engineering Firms Involved in Dental Products
2.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products
2.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets
2.2 Cell Therapy
2.2.1 Progress in Cell Therapy Product Research
2.2.2 Commercially Available Cell Therapy Products
2.2.3 Major Cell Therapy Companies
2.2.4 Locations of Cell Therapy Companies
2.2.5 Disease Focus by Cell Therapy
2.2.6 Cell Therapy Products and Companies
2.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc.
2.2.7 Potential Patients for Cell Therapy in the U.S.
2.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy
2.2.9 Cell Therapy Pipeline
2.2.10 Cell Therapy Clinical Trials by Indication
2.2.10.1 Major Cell Therapy Clinical Trials for Diabetes
2.2.10.2 Progress in Clinical Trials for Diabetes
2.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes
2.2.11 Major Four Targeted Disease Conditions for Clinical Trials
2.2.12 Commercial Success of Cell Therapies in Europe
2.2.13 Deals in Cell Therapy, 2007-2011
2.2.14 Commercial-Stage Cell Therapy Companies and Products
2.2.15 Cell Therapy Clinical Trials in the U.K.
2.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the U.K.
2.2.15.2 Cell Types Involved in the U.K. Clinical Trials
2.2.15.3 U.K. Cell Therapy Clinical Trials by Indication
2.3 Cell Culture Products
2.3.1 Market for Reagents Used in Cell Culture
2.3.2 Cell Culture Media
2.3.3 Market for Sera Used in Cell Culture
2.3.3.1 Suppliers of Culture Media and Reagents
2.3.3.2 In Vitro Test Kits
2.3.3.3 Suppliers of Cells and Tissues
2.3.3.4 Equipment for Stem Cell Research
2.3.3.5 Computer Software for Stem Cell Research
2.4 Scaffolding Biomaterials
2.5 Growth Factors

3. Regenerative Medicine: The Next Evolution of Medical Treatment
3.1 Scope of this Chapter
3.2 Need for Regenerative Medicine
3.3 Current State of Regenerative Medicines
3.4 Future of Regenerative Medicine
3.4.1 Number of Products in Pipeline
3.5 Projected Timeline for Regenerative Medicine
3.6 Selected Regenerative Medicine Products in the Market
3.6.1 Medtronics Infuse Bone Graft and LT-Cage Device
3.6.2 Genzymes Corticel
3.6.3 OP-1 from Stryker
3.6.4 Osteocel from Osyris/Nuvasive
3.6.5 Spinal Implants from RTI Biologics
3.6.6 Apligraf from Organogenesis
3.6.7 Dermograft from Advanced BioHealing
3.6.8 Integras Bilayer Matrix for Wound Dressing
3.6.9 Alloderm from LifeCell
3.6.10 Celution from Cytori Therapeutics
3.6.11 Other Products of Importance in Regenerative Medicine
3.6.12 Tissue-Engineered Wound Healing Products
3.6.12.1 Oasis
3.6.12.2 Permacol
3.6.12.3 EZ-Derm
3.6.12.4 Matriderm
3.6.12.5 TransCyte
3.6.12.6 ICX-SKN
3.6.12.7 OrCel
3.6.12.8 Epicel
3.6.12.9 Myskin
3.6.12.10 VCT01
3.6.13 ICX-TRC Hair Regeneration Therapy
3.6.14 Cartilage Regeneration
3.6.14.1 Novocart
3.6.14.2 BioSeed-C
3.6.14.3 BioSeed Oral Bone
3.6.14.4 Chondrotissue
3.6.14.5 co.don Chondrotransplant
3.6.14.6 co.don Chondrotransplant DISC
3.6.14.7 co.don Chondrosphere
3.6.14.8 co.don Osteotransplant DENT
3.6.14.9 MACI Implant
3.6.14.10 Cartilink-3
3.6.14.11 Accell Evo3 Demineralized Bone Matrix
3.6.14.12 OsSatura BCP
3.6.15 Mozobil
3.7 Clinical Milestones in RM Sector, 2011-2012
3.7.1 GINTUIT (March 2012)
3.7.2 Ixmyelocel-T (February 2012)
3.7.3 Autologous CD34+ Stem Cells (February 2012)
3.7.4 HuCNS-SC (February 2012)
3.7.5 DeNovo ET (February 2012)
3.7.6 Retinal Pigment Epithelium Cells (January 2012)
3.7.7 AMR-001 (January 2012)
3.7.8 Avance Nerve Graft (January 2012)
3.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia (January 2012)
3.7.10 T-Cells Resistant to HIV (January 2012)
3.7.11 Tissue-Engineered Windpipe (November 2011)
3.7.12 Revascor (November 2011)
3.7.13 ReN001 Stem Cell Therapy (September 2011)
3.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers (August 2011)
3.7.15 ALD-301 for Critical Limb Ischemia (May 2011)
3.7.16 JVS-100 for Heart Failure (April 2011)
3.7.17 MultiStem for Ulcerative Colitis (March 2011)
3.7.18 HuCNS-SC Human Neural Stem Cells (March 2011)
3.8 Accelerated Pace of Deals in RM Sector
3.8.1 Acquisitions and Partnerships
3.8.1.1 Shires Acquisition of Advanced BioHealing, Inc. (May 2011)
3.8.1.2 Terumo Americas Holdings Acquisition of Harvest Technologies (April 2011)
3.8.1.3 Sanofis Acquisition of Genzyme Corporation (February 2011)
3.8.1.4 NeoStems Acquisition of Progenitor Cell Therapy, LLC (January 2011)
3.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. (December 2011)
3.8.2 Notable Financings
3.8.2.1 Financing to AlloCure, Inc. (April 2012)
3.8.2.2 Financing to Promethera Biosciences (March 2012)
3.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. (February 2012)
3.8.2.4 Financing to Organovo (March 2012)
3.8.2.5 Financing to Cytomedix, Inc. (February 2012)
3.8.2.6 Financing to Fate Therapeutics, Inc. (May 2011)
3.8.2.7 Financing to Cellular Dynamics International, Inc. (April 2011)
3.8.2.8 Financing to Cytori Therapeutics (December 2010)
3.8.2.9 Overview of Capital Formation in RM Industry

4. Recent Advances in Regenerative Medicine and Stem Cell Research
4.1 Bioengineered Autologous Vein
4.2 Stem Cell Treatment for Spinal Cord Injury
4.3 Repairing Damaged Retina
4.4 A Possible Cure for Deafness
4.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc.
4.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem Cells
4.6.1 Recent Developments in Stem Cell Therapy in Cardiology
4.6.2 Recent Developments in Acute MI
4.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure
4.6.4 Stem Cells and Neurodegenerative Diseases
4.7 Disease Modeling: The Use of Inducible Cells
4.7.1 Modeling Disease with iPS Cells
4.7.2 Modeling Disease with Direct Neuronal Conversion
4.8 Stem Cell Transplants
4.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies
4.8.2 Stem Cell Types for Eye Disease Clinical Trials
4.8.2.1 Pluripotent Stem Cells
4.8.2.2 Neural Stem Cells
4.8.2.3 RPE Stem Cells
4.8.2.4 Limbal Stem Cells
4.8.2.5 Umbilical Cord Stem Cells
4.8.2.6 Bone Marrow Stem Cells
4.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration
4.8.2.8 Patch of hESC-Derived RPE Monolayer
4.8.2.9 Patient-Derived RPE
4.8.2.10 NSCs for AMD
4.8.2.11 UCSCs for RP and AMD
4.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases
4.8.2.13 Corneal Repair
4.8.2.14 Bioengineered Eye Tissues
4.9 Regenerative Strategies in the Treatment of Diabetes
4.9.1 Cell-Based Therapy for Diabetes
4.9.2 Embryonic Stem Cells and Induced Pluripotent Cells

5. Stem Cell Industry Highlights, 2012
5.1 Business Development
5.2 Clinical Trials
5.3 Market Authorization
5.4 Regulations
5.5 Capital Market and Finances
5.6 Investments in Xeno-Cell Therapy
5.7 Collaborations in Stem Cell Science
5.7.1 California Institute for Regenerative Medicine (CIRM)
5.7.2 The International Translational Regenerative Medicine Center

6. Regenerative Medicines: A Brief Update from Selected Countries
6.1 U.S.
6.1.1 Key Institutions
6.1.1.1 California Institute for Regenerative Medicine
6.1.1.2 The New York Stem Cell Foundation
6.1.1.3 NIH Center for Regenerative Medicine
6.1.2 Innovative Company
6.1.2.1 Aastrom Biosciences
6.2 Canada
6.2.1 Key Institutions
6.2.1.1 Institute of Biomaterials & Biomedical Engineering, University of Toronto
6.2.1.2 Terry Fox Research Institute
6.2.1.3 Institute for Research in Immunology and Cancer, University of Montreal
6.2.2 Innovative Companies
6.2.2.1 Northern Therapeutics
6.2.2.2 Octane Biotech
6.3 U.K.
6.3.1 Key Institutions
6.3.1.1 Loughborough University
6.3.1.2 U.K. Stem Cell Foundation
6.3.1.3 University College, London
6.3.2 Innovative Companies
6.3.2.1 Intercytex
6.3.2.2 Azellon Cell Therapeutics
6.3.2.3 Cell Medica
6.4 Sweden
6.4.1 Key Institutions
6.4.1.1 Karolinska Institutet
6.4.1.2 The University of Lund
6.4.2 Innovative Companies
6.4.2.1 Vitrolife
6.4.2.2 Cellartis
6.4.2.3 Biolamina
6.5 Brazil
6.5.1 Key Institutions
6.5.1.1 Universidade de SaoPaulo
6.5.1.2 Fiocruz and Hospital Sao Rafael
6.5.1.3 Universidade Federal do Rio de Janeiro
6.5.1.4 Pontificia Universidade Catolica do Parana
6.5.2 Innovative Company
6.5.2.1 Excellion & CellPraxys

7. Market Analysis for Regenerative Medicine Sector
7.1 Scope of this Chapter
7.2 Opportunities for RM Products
7.3 Commercial RM Products
7.3.1 Leading Commercial Cell Therapy Products
7.3.2 FDA Approved Cell-Based Products
7.3.3 Growth Spurt by Regenerative Medicine (RM)
7.4 Global Market for Tissue-Engineered Products
7.4.1 Tissue Engineering and Stem Cell Industry
7.5 Market for Stem Cell Therapy in Cardiology
7.6 Market for RM Products in Orthopedics
7.6.1 No Strong Alternatives for Medtronics INFUSE
7.6.2 Demineralized Bone Matrix (DBM)
7.6.3 The Unproven Stem Cells in Orthopedics
7.6.4 Future of Bone Replacement Market
7.7 Global RM Market for Neurology Products
7.8 Market for RM Dental Products
7.9 Market for RM Cancer Products
7.10 RM Market for Urology Products
7.11 Global Market for Skin Products
7.12 Overall Global RM Market
7.13 U.S. Market for Tissue-Engineered Skin
7.14 U.S. RM Market for Orthopedic/Spine Products
7.15 U.S. RM Market for Nerve Repair Products
7.16 U.S. RM Market for Cardiovascular and Stroke Products
7.17 U.S. Market for Anti-Inflammatory RM Products
7.18 U.S. Market for RM Products in Diabetes
7.19 Overall U.S. Regenerative Medicine Market
7.19.1 U.S. RM Market by Segment

8. Stem Cell Industry
8.1 Global Market for Stem cells
8.2 Stem Cell Use in the U.S.
8.2.1 Autologous Stem Cell Use in the U.S.
8.2.2 U.S. Stem Cell Market Overview
8.2.2.1 Potential U.S. Population for Cell-Based Therapies
8.2.3 U.S. Market for Stem cells
8.3 European Market for Stem Cells
8.3.1 Autologous and Allogeneic Cell Therapy Companies in Europe
8.4 Asia-Pacific Market for Stem Cells
8.5 Autologous Cell Therapy
8.5.1 Commercially Available Autologous Treatments
8.5.1.1 Autologous Cell Therapy for Alzheimers disease
8.5.1.2 Autologous Cell Therapy for Multiple Sclerosis
8.5.1.3 Autologous Cell Therapy for Wound Healing
8.5.1.4 Autologous Therapy for Cosmetic Surgery

9. Business Models and Requirements for a Successful Regenerative Medicine Industry
9.1 Scope of this Chapter
9.2 Business Models in Regenerative Medicine
9.2.1 Current Model for Autologous Cell Therapies
9.2.2 Current Models for Allogeneic Cell Therapies
9.3 Key Factors for Successful Business Models for Cell Therapies
9.4 Requirements for Commercial Manufacturing of Cell Therapy Products
9.4.1 Elements of Commercial Manufacturing
9.4.1.1 Regulatory Requirements
9.4.1.2 Manufacturing Process Scale
9.4.1.3 In-House Manufacturing
9.4.1.4 Contract Manufacturing: Commercial and Academic

10. Company Profiles
10.1. Aastrom Biosciences, Inc.
10.1.1 Aastroms Cellular Therapy and Ixmyelocel-T
10.1.1.1 Advantages of Patients Bone Marrow and Ixmyelocel-T
10.1.2 Aastroms Clinical Trials
10.1.2.1 REVIVE-CLI
10.1.2.2 RESTORE-CLI
10.2 Advanced Cell Technology, Inc. (ACT)
10.2.1 ACTs Human ES Cell Programs
10.2.2 ACTs Human Embryonic Stem Cell Technologies
10.2.3 ACTs Cell Therapy Research Program
10.2.3.1 Retinal Pigment Epithelium Program
10.2.3.2 Hemangioblast Program
10.2.3.3 Adult Stem Cell Program
10.2.4 ACTs Intellectual Property
10.3 AlloCure, Inc.
10.3.1 AlloCures Technology
10.3.2 AlloCures Clinical Trials
10.3.2.1 Acute Kidney Injury
10.3.2.2 Epidemiological Study of AKI
10.3.2.3 Phase I Clinical Trial in AKI
10.3.2.4 Phase II Clinical Trial in AKI
10.4 Altrika Ltd.
10.4.1 Myskin
10.4.2 Cryoskin
10.5 American Type Culture Collection, Inc. (ATCC)
10.5.1 ATCCs Cell Lines and Hybridomas
10.5.2 ATCCs Media, Sera and Reagents
10.5.3 MTT Cell Proliferation Assay
10.5.4 XTT Cell Proliferation Assay Kit
10.5.5 Universal Mycoplasma Detection Kit
10.5.6 DNA and RNA
10.5.7 STR Profile Database
10.5.8 hTERT Immortalized Cell Lines
10.5.9 Embryonic Stem Cell Products
10.5.10 Bacteria and Phages
10.5.11 Fungi and Yeast
10.5.12 Protozoa and Algae
10.5.13 Viruses and Related Reagents
10.5.14 Microbial DNA and RNA
10.5.15 ATCCs Tissue Biology Products
10.6 Avita Medical Limited
10.6.1 ReCell
10.7 Amorcyte, LLC
10.7.1 AMR-001
10.8 Ars Arthro AS
10.8.1 CaReS
10.8.2 Fibrocell
10.8.3 Fibroplus
10.9 Axiogenesis AG
10.9.1 Human iPS Cell-Derived Cardiomyocytes
10.9.2 Murine Cardiomyocytes ES
10.9.3 Murine Cardiomyocytes iPS
10.9.4 Murine Endothelial Cells
10.9.5 Murine Smooth Muscle Cells
10.10 AxoGen, Inc.
10.10.1 Avance Nerve Graft
10.10.2 AxoGuard Nerve Protector
10.10.3 AxoGuard Nerve Connector
10.11 Bellicum Pharmaceuticals, Inc.
10.11.1 Bellicums Technology
10.11.2 Bellicums Pipeline
10.12 BetaStem Therapeutics, Inc.
10.12.1 BetaStems Technology
10.13 Bioheart, Inc.
10.13.1 MyoCell
10.13.2 MyoCell SDF-1
10.13.3 MyoCath
10.13.4 LipiCell
10.14 Biomet, Inc.
10.14.1 Endobon Xenograft Granules
10.14.2 RegenerOss Allograft
10.14.3 Ground Cancellous Bone
10.15 BioMimetic Therapeutics, Inc.
10.15.1 Augment Bone Graft
10.15.2 Augmatrix Biocomposite Bone Graft
10.16 BioTissue Technologies AG
10.16.1 BioSeed-C
10.16.2 Chondrotissue
10.16.3 BioSeed-Oral Bone
10.17 Biovest International, Inc.
10.17.1 Autovaxid
10.17.2 Xcellerator
10.17.3 Maximizer
10.17.4 Minimax
10.18 BrainStorm Cell Therapeutics, Inc.
10.18.1 NurOwn
10.19 California Stem Cell, Inc.
10.19.1 Clinical Pipeline
10.19.1.1 MotorGraft
10.19.1.2 Cancer Stem Cell
10.19.2 Cell Products
10.19.2.1 MotorPlate and MotorVial
10.19.2.2 NeuroPlate and NeuroVial
10.19.2.3 OPCVial
10.19.2.4 HepatoPlate
10.19.3 Cell Culture Products
10.19.3.1 StemBlast
10.19.3.2 MotorBlast
10.19.3.3 NeuroBlast
10.19.3.4 OPC Media
10.19.3.5 Cellular Transplant Solution
10.20 Cardio3 Biosciences SA
10.20.1 Products Pipeline
10.20.1.1 C3BS-CQR-1 (C-Cure)
10.20.1.2 Positive Phase II Results for C-Cure
10.20.1.3 C3BS-CQR-1 (Protein)
10.20.1.4 C-CATHez (Medical Device)
10.21 Cellartis AB (Cellectis)
10.21.1 iPS Engineering Hub
10.21.2 Hepatocytes hiPS-HEP
10.21.3 Cardiomyocyte Clusters hES-CMC
10.21.4 Stem Cell Culture System DEF-CS
10.22 CellSeed, Inc.
10.22.1 Epithelial Cell Sheet for Corneal Regeneration
10.22.2 Regenerated Cardiac Patch
10.22.3 Epithelial Cell Sheet for Esophageal Regeneration
10.22.4 Cell Sheet for Periodontal Regeneration
10.22.5 Regenerated Cartilage Sheet
10.23 Cellular Dynamics International, Inc.
10.23.1 iCell Cardiomyocytes
10.23.2 iCell Endometrial Cells
10.23.3 iCell Hepatocytes
10.23.4 iCell Neurons
10.23.5 MyCell Products
10.24 Chromocell Corporation
10.24.1 Chromovert Technology
10.24.2 Chromovert Applications
10.24.2.1 Pain Relief
10.24.2.2 Anxiety Treatments
10.24.2.3 Respiratory Disorders
10.25 Cognate Bioservices, Inc.
10.25.1 Process Development
10.25.2 Regulatory Services
10.25.3 Assay Development
10.25.4 Preclinical Services
10.25.5 Stem Cell Services
10.26 Cook Biotech, Inc.
10.26.1 Cooks Technology
10.26.2 Biodesign Dural Graft
10.26.3 Dynamatrix Extracellular Membrane
10.26.4 tarSys
10.26.5 Oasis Wound Matrix
10.26.6 Biodesign Staple Line Reinforcement
10.26.7 Biodesign Hiatal Hernia Graft
10.26.8 CorMatrix ECM
10.26.9 ECM for Cardiac Tissue Repair
10.26.10 Biodesign Incision Graft
10.26.11 Biodesign Inguinal Hernia Graft
10.26.12 Biodesign Parastomal Reinforcement Graft
10.26.13 Biodesign Umbilical Hernia Graft
10.26.14 Biodesign Anterior Pelvic Floor Graft
10.26.15 Biodesign Fistula Plug
10.26.16 LIFT with Biodesign
10.26.17 Biodesign Posterior Pelvic Floor Graft
10.26.18 Biodesign Peyronies Repair Graft
10.26.19 Biodesign Tension-Free Urethral Sling
10.27 Cytomedix, Inc.
10.27.1 Cytomedixs AutoloGel System
10.27.1.1 The Working of AutoloGel System
10.27.1.2 Balancing Effect of AutoloGel System
10.27.1.3 Formulation of AutoloGel System
10.27.2 Cytomedixs Angel PRP
10.28 Cytonet, LLC
10.28.1 Cytonets Liver Cell Therapy
10.28.2 SELICA III Clinical Trial
10.29 Cytori Therapeutics, Inc.
10.29.1 Cytoris Commercial Activities and Markets
10.29.2 Cytoris Pipeline
10.29.2.1 Celution System for Cardiovascular Disease
10.29.2.2 Other Applications of Celution System
10.29.2.3 PureGraft
10.29.2.4 StemSource
10.30 DanDrit Biotech A/S
10.30.1 Dendritic Cell
10.30.1.2 Colorectal Cancer Trial Phase II in Singapore
10.30.1.3 Non-Small-Cell Lung Cancer, Phase II
10.31 Fibrocell Science, Inc.
10.31.1 Fibrocells Technology
10.31.2 Pipeline
10.32 Forticell Bioscience, Inc.
10.32.1 OrCel
10.33 Gamida Cell Ltd.
10.33.1 Gamidas Technology
10.33.1.1 Copper Chelator Based Technology
10.33.1.2 NAM Based Technology
10.33.1.3 StemEx
10.33.1.4 NiCord
10.33.1.5 CordBridge
10.33.1.6 NK Cell Product
10.34 Harvest Technologies Corporation
10.34.1 Smart PReP2 APC+
10.34.2 SmartPReP 2 BMAC
10.35 Histogenics Corporation
10.35.1 NeoCart
10.35.2 VeriCart
10.36 Humacyte, Inc.
10.36.1 Humacyte Grafts
10.37 Integra Lifesciences Holdings Corporation
10.37.1 Integras Products Overview
10.37.2 Integras Orthopedics Product Portfolio
10.37.3 Integras Extremity Reconstruction Product Portfolio
10.37.3.1 Skin and Wound
10.37.3.2 Bone and Joint Fixation Devices and Instruments
10.37.3.3 Lower Extremity Products
10.37.3.4 Upper Extremity Products
10.37.3.5 Bone Graft Substitutes for Extremity Reconstruction
10.37.3.6 Nerve and Tendon
10.37.4 Integras Spine Product Portfolio
10.37.4.1 Integrated Interbody Fusion Devices
10.37.4.2 Minimally Invasive Solutions
10.37.4.3 Deformity Correction
10.37.4.4 Orthobiologics
10.37.4.5 Integras Research and Development in Regenerative Medicine
10.38 Intercytex Ltd.
10.38.1 VAVELTA
10.38.2 Epidermolysis Bullosa
10.38.3 Scar Contractures
10.38.4 Acne Scarring
10.38.5 International Stem Cell Corporation
10.38.6 Therapeutic Programs
10.39 iPierian, Inc.
10.39.1 Technology
10.39.2 Product Development
10.40 Japan Tissue Engineering Co., Ltd.
10.40.1 Autologous Cultured Epidermis
10.40.2 Autologous Cultured Cartilage
10.40.3 Autologous Cultured Corneal Epithelium
10.41 Kensey Nash Corporation
10.41.1 Medeor Matrix
10.41.2 Meso BioMatrix Scaffold
10.41.3 Epi-Guide Bioresorbable Barrier Matrix
10.41.4 OsseoFit Porous Tissue Matrix
10.41.5 Vitoss Scaffold Foam Products
10.42 Kiadis Pharma B.V.
10.42.1 Kiadis Pipeline
10.42.1.1 ATIR
10.42.1.2 Reviroc
10.42.1.3 Rhitol
10.43 Living Cell Technologies Limited (LCT)
10.43.1 Diabecell
10.43.2 Ntcell
10.44 Life Cell Corporation
10.44.1 AlloDerm
10.44.2 Cymetra Micronized AlloDerm Tissue
10.44.3 Strattice Reconstructive Tissue Matrix
10.44.4 SPY Elite System
10.45 MaxCyte, Inc.
10.45.1 MaxCytes Technology Platform
10.45.2 Drug Discovery Applications
10.45.2.1 GPCRs
10.45.2.2 Ion Channels
10.45.3 Antibody Production
10.45.4 General Protein Production
10.45.5 Viral Vector and VLP Production
10.45.6 Insect Cell Transfection
10.45.7 Cell Therapy
10.45.7.1 Dendritic Cell Vaccines
10.45.7.2 Regenerative Medicine
10.45.7.3 Chimeric Antigen Receptor (CAR) Immunotherapy
10.46 MediStem, Inc.
10.46.1 Intellectual Property
10.46.1.1 Method for Expansion of Stem Cells
10.46.1.2 Compositions of Placentally-Derived Stem Cells for the Treatment of Cancer
10.46.1.3 Transcatheter Tumor Immunoembolization
10.46.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction
10.46.1.5 Treatment of Erectile Dysfunction by Stem Cell Therapy
10.46.1.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients
10.46.1.7 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation
10.46.1.8 Cellular Therapy for Lower Back Pain
10.46.1.9 Compositions and Methods of Stem Cell Therapy for Autism
10.46.1.10 Stem Cell Therapy for Weight Loss
10.46.1.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof
10.46.1.12 Endometrial Derived Reparative/Regenerative Cells
10.46.1.13 Treatment of Insulin Resistance and Diabetes
10.46.1.14 Combination Treatment of Cardiovascular Disease
10.46.1.15 Stem Cell Therapy for Autism
10.46.2 Product Pipeline
10.46.2.1 Endometrial Regenerative Cell Platform
10.46.2.2 Angiostem Platform
10.46.2.3 Tolerostem Platform
10.47 Mesoblast Ltd.
10.47.1 Revascor
10.47.2 MPCs for Diabetics
10.47.3 Bone Marrow Derived Allogeneic MPCs
10.47.4 Macular Degeneration
10.47.5 Diabetic Macular Edema
10.47.6 Intervertebral Disc Repair Product
10.47.7 Lumbar and Cervical Spinal Fusion Product
10.47.8 Fracture Repair Product
10.47.9 Arthritis Product
10.48 MolMed S.p.A.
10.48.1 MolMeds Technological Platforms
10.49 NanoCor Therapeutics, Inc.
10.49.1 Carfostin
10.50 Neuralstem, Inc.
10.50.1 Neuralstems Technology Platforms: Stem Cells
10.50.2 Pharmaceutical Compounds
10.50.3 Neuralstems Clinical Trials for Stem Cells
10.50.4 Clinical Trials for Neuralstem?s Pharmaceutical Compound
10.51 NeuroNova AB
10.51.1 Neurogenesis Qualifier
10.51.2 NeuroNovas Projects
10.52 Olympus Terumo Biomaterials Corp.
10.52.1 OSferion60
10.52.2 Terudermis
10.52.3 OSferion
10.52.4 Teruplug
10.52.5 Bone Cream
10.53 NewLink Genetics Corporation
10.54 OncoMed Pharmaceuticals, Inc.
10.54.1 OncoMeds Research on Cancer Stem Cells
10.54.2 OncoMeds Platform
10.54.3 OncoMeds Development Pipeline
10.55 Opexa Therapeutics, Inc.
10.55.1 T-Cell Platform
10.56 Organogenesis, Inc.
10.56.1 Apligraf
10.56.2 Gintuit
10.57 Orthovita, Inc.
10.57.1 Vitoss
10.58 Osiris Therapeutics, Inc.
10.58.1 Osiris Technologies
10.58.1.1 Stem Cell Source
10.58.1.2 Manufacturing Process
10.59 Osteotech, Inc.
10.59.1 MagniFuse
10.59.2 Plexur P
10.59.3 Plexur M
10.59.4 FacetLinx Fusion Technology
10.59.5 Grafton
10.59.6 Xpanse Bone Inserts
10.59.7 GraftCage TLX and GraftCage ACX
10.60 Pervasis Therapeutics, Inc.
10.61 Pluristem Therapeutics, Inc.
10.62 Proneuron Biotechnologies, Inc.
10.62.1 Spinal Cord Technology
10.63 RegeneRx
10.63.1 T4 Peptide Research
10.64 ReNeuron Group PLC
10.64.1 ReN001
10.64.2 ReN009
10.64.3 ReNcell VM and ReNcell CX
10.65 Revivicor, Inc.
10.65.1 Xenotransplantation Technology
10.66 SanBio, Inc.
10.66.1 SanBios Product Pipeline
10.66.1.1 SB623
10.66.1.2 SB618
10.66.1.3 SB308
10.67 Saneron CCEL Therapeutics, Inc.
10.67.1 U-Cord Cell Program
10.67.2 Sert-Cell Program
10.68 Sangamo Biosciences, Inc.
10.68.1 SB-728
10.68.2 SB-313
10.68.3 Hemophilia
10.69 Stem Cell Authority Ltd.
10.69.1 MIRACHYMAL Stem Cells
10.70 StemCells, Inc.
10.70.1 StemCells Research Collaborations
10.70.1.1 Stanford University and Stanford School of Medicine
10.70.1.2 UC Irvine
10.70.1.3 OHSU Casey Eye Institute
10.70.1.4 McLaughlin Research Institute
10.70.2 StemCells Therapeutic Programs
10.70.3 Cells and Cell Lines
10.70.4 Cell Culture Products
10.70.5 Antibody Detection Reagents
10.70.6 Purified Whole Stem Cell Lysates
10.71 Stemline Therapeutics, Inc.
10.71.1 Cancer Stem Cells
10.71.2 Stemline Therapeutics Platform
10.72 Stratetech Corporation
10.72.1 Stratatechs Core Technology
10.73 Synthecon, Inc.
10.73.1 Rotary Cell Culture Systems
10.73.2 Biofelt (Bioabsorbable Scaffold)
10.73.3 Biomerix 3D Scaffolds
10.73.4 RollerCell 40
10.74 Tengion, Inc.
10.74.1 Tengions Scientific Platform
10.74.2 Tengions Pipeline
10.75 TiGenics NV
10.75.1 ChondroCelect
10.75.2 CX601
10.75.3 Cx611
10.75.4 Cx621
10.76 Tissue Genesis, Inc.
10.76.1 Clinical Therapies from Tissue Genesis
10.76.1.1 Icellator
10.76.1.2 Adipase
10.77 Thermogenesis Corp.
10.77.1 AXP System
10.77.2 MXP System
10.77.3 Manual Systems
10.77.4 Res-Q 60 BMC System
10.77.5 BioArchive System
10.78 ViaCyte, Inc.
10.78.1 Technology Overview
10.79 Vistagen Therapeutics, Inc.
10.79.1 Vistagens Technology
10.79.2 CardioSafe 3D
10.79.3 LiverSafe 3D
10.80 Zen-Bio, Inc.

Appendix 1: Allogeneic vs. Autologous Stem Cell Therapy
Appendix 1.1: Manufacturing Process
Appendix 1.2: Cost Differential
Appendix 1.3: Donor Screening and Testing
Appendix 1.4: Release Testing
Appendix 1.5: Overall Analysis


INDEX OF FIGURES

Figure 2.1: Geographic Distribution of Tissue Engineering Firms in Major Markets
Figure 2.2: The Potential Uses of Embryonic Stem Cells
Figure 2.3: Progress of Cell Therapy Product Research, 2012
Figure 2.4: Commercially Available Cell Therapy Products, 2012
Figure 2.5: Disease Focus by Regenerative Medicine
Figure 2.6: Estimated Completion Dates for Stem Cell Based Clinical Trials Targeting Type 1 Diabetes,
2009-2015
Figure 2.7: Number of Clinical Trials by Targeted Condition, 2005-2011
Figure 2.8: Concentration of European Cell Therapy Firms, 2012
Figure 2.9: European Stem Cell Platforms by Cell Source
Figure 2.10: Autologous vs. Allogeneic Stem Cell Therapy Firms in Europe, 2012
Figure 2.11: Autologous and Allogeneic Somatic Cell Therapy Firms in Europe, 2012
Figure 2.12: Sponsors of Cell Therapy Clinical Trials in the U.K., 2012
Figure 2.13: Clinical Trials Involving Allogeneic vs. Autologous Cell Therapy Products in the U.K., 2012
Figure 2.14: Cell Types Involved in the U.K. Cell Therapy Clinical Trials, 2012
Figure 2.15: U.K. Cell Therapy Clinical Trials by Indication, 2012
Figure 2.16: Cell Culture Products Market by Segment, 2012
Figure 2.17: Market for Reagents Used in Cell Culture, 2012-2019
Figure 2.18: Market for Media Used in Cell Culture, 2012-2019
Figure 2.19: Market for Serum Used in Cell Culture, 2012-2019
Figure 5.1: CIRM?s Grants for Disease Types by Funding Level, 2012
Figure 7.1: Commercially Available Regenerative Products
Figure 7.2: Global Market for Tissue Engineering Products, 2012-2019
Figure 7.3: Global RM Market for Cardiology and Vascular Products, 2012-2019
Figure 7.4: Alternatives for Medtronic?s Infuse
Figure 7.5: Global Market for RM Products in Orthopedics, Musculoskeletal and Spine, 2012-2019
Figure 7.6: Global RM Market for Neurology Products, 2012-2019
Figure 7.7: Global RM Market for Dental Products, 2012-2019
Figure 7.8: Global Tissue Engineering and Cell Therapy Market for Cancer Products, 2012-2019
Figure 7.9: Global Market for RM Products in Urology, 2012-2019
Figure 7.10: Global Market for RM Products in Skin/Integument, 2012-2019
Figure 7.11: Global Tissue Engineering and Cell Therapy Market, 2012-2019
Figure 7.12: U.S. Market for Tissue Engineered Skin Replacement and Substitutes, 2012-2019
Figure 7.13: U.S. Market for RM Products in Orthopedic/Spine, 2012-2020
Figure 7.14: U.S. Market for RM Products in Nerve Repair, 2012-2020
Figure 7.15: U.S. Market for RM Products in Cardiovascular Therapies, 2012-2020
Figure 7.16: U.S. Market for RM Products in Anti-Inflammatory Therapies, 2012-2020
Figure 7.17: U.S. Market for RM Products in Diabetes, 2012-2020
Figure 7.18: U.S. Market for Regenerative Medicines, 2012-2020
Figure 7.19: U.S. Regenerative Medicine Market by Segment, 2020
Figure 8.1: Global Market for Stem Cell Products, 2012-2020
Figure 8.2: U.S. Market for Stem Cell Products, 2012-2020
Figure 8.3: Estimated U.S. Market for Stem Cell Therapy by Type, 2020
Figure 8.4: European Market for Stem Cell Products, 2012-2020
Figure 8.5: Number of Autologous and Allogeneic Cell Therapy Firms in Europe
Figure 8.6: Asia-Pacific Market for Stem Cells, 2012-2019
Figure 8.7: Global Autologous Cell Therapy Market, 2012-2019
Figure 9.1: Cell-Based Business Models
Figure 9.2: Current Autologous Business Models
Figure 9.3: Current Allogeneic Business Models
Figure 10.1: Aastrom?s Cell Expansion Process


INDEX OF TABLES

Table 2.1: Commercially Available Bioengineered Skin Products
Table 2.2: A Partial List of Companies Offering Bioreactor Systems
Table 2.3: Number of Tissue Engineering Companies in the Five Focus Countries
Table 2.4: Number of Tissue Engineering Firms Developing Stem Cells Seeded to Scaffolds
Table 2.5: Number of Tissue Engineering Firms Focusing on Skin, Cartilage, Bone and Urological
Products
Table 2.6: Number of Tissue Engineering Firms Focused on Cardiovascular Products
Table 2.7: Number of Tissue Engineering Firms Focusing on Neurological Products
Table 2.8: Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney
Table 2.9: Number of TE Firms Focused on Autologous and Allogenic Products
Table 2.10: Major Cell Therapy Companies
Table 2.11: Geographical Distribution of Cell Therapy Companies
Table 2.12: Cell Therapy Products on the Market
Table 2.13: Cell Therapy Products on the Market by Type and Application
Table 2.14: Potential Patients for Cell Therapy in the U.S.
Table 2.15: Number of Patients Treated with Cell Therapy Between 1988 and 2010
Table 2.16: Cell Therapy Pipeline, 2005-2011
Table 2.17: Number of Stem Cell Clinical Trials by Indication, 2012
Table 2.18: Major Cell Therapy Clinical Trials for Diabetes and Estimated Enrollment Targets, 2012
Table 2.19: Progress in Clinical Trials for Diabetes, 2012
Table 2.20: Cell Therapy Deals, 2007-2011
Table 2.21: Select Cell Therapy Products with FDA/EMA Regulatory Approval, 1998-2010
Table 2.22: Cell Therapy Companies and Products
Table 2.23: Cell Therapy Products Approved in South Korea
Table 2.24: Selected Suppliers of Culture Media and Reagents
Table 2.25: Selected Suppliers of In Vitro Test Kits
Table 2.26: Selected Suppliers of Cells and Tissues
Table 2.27: Selected Suppliers of Equipment for Stem Cell Research
Table 2.28: Selected Companies Offering Computer Software for Stem Cell Research
Table 3.1: Industry Participants in Regenerative Medicine
Table 3.2: Top Ten Regenerative Medicine Products in the Market
Table 3.3: Industry-Sponsored Active Cell Therapy Trials, 2007 and 2012
Table 4.1: Recently Published Stem Cell Therapy Clinical Trials for Ischemic Heart Disease
Table 5.1: CIRM Funding for Projects Moving Towards Disease Therapies, 2012
Table 5.2: List of CIRM Funded Institutions, 2012
Table 7.1: A Sampling of Leading Commercial Cell Therapy Products, 2012
Table 7.2: FDA-Approved Cell-Based Products, 1997-2012
Table 7.3: Ongoing and Reported Clinical Trials in Ischemic Heart Disease
Table 7.4: Human Skin Equivalents for Clinical Skin Replacements and Grafts
Table 7.5: Human Skin Models for Drug Permeability Tests and Toxicity Screening
Table 8.1: Cell Therapy Products Revenue, 2010-2011
Table 8.2: Market Capitalization of Public Stem Cell Companies, 2011 vs. 2010
Table 8.3: Potential U.S. Population for Cell-Based Therapies
Table 8.4: Non-Autologous and Autologous Skin Substitutes and Dermal Treatments for Other
Applications
Table 9.1: The Required Elements of a Manufacturing Facility
Table 9.2: Cell Therapy CMO Qualification Audit: Points to Investigate
Table 10.1: ACT?s Pipeline of Therapeutic Programs
Table 10.2: Patents Owned by ACT
Table 10.3: Patents Owned by ACT?s Subsidiary Mytogen, Inc.
Table 10.4: Patents Licensed to ACT by the University of Massachusetts
Table 10.5: Bellicum?s Pipeline
Table 10.6: Bioheart?s Intellectual Property
Table 10.7: Cardio3 Biosciences? Products Pipeline
Table 10.8: Gamida?s Pipeline Overview
Table 10.9: International Stem Cell Corporation?s Therapeutic Programs
Table 10.10: Kiadis? Pipeline
Table 10.11: MolMed?s Pipeline
Table 10.12: NeuroNova?s Projects
Table 10.13: NewLink?s Pipeline Overview
Table 10.14: OncoMed?s Development Pipeline
Table 10.15: Vitoss Bone Graft Substitutes
Table 10.16: Osiris? Product Pipeline
Table 10.17: Pervasis? Pipeline
Table 10.18: Pluristem?s Product Candidates Pipeline
Table 10.19: Proneuron?s Pipeline
Table 10.20: RegeneRx?s Pipeline/Clinical Trials
Table 10.21: RegeneRx?s T ? Peptide Research
Table 10.22: SanBio?s Product Pipeline
Table 10.23: Sangamo?s Product Pipeline
Table 10.24: StemCells? Broad Pipeline
Table 10.25: Stemline Therapeutics? Clinical Programs
Table 10.26: Stemline Therapeutics? Preclinical Programs
Table 10.27: Stratatech?s Product Pipeline
Table A1.1: Comparison of Autologous and Allogeneic Stem Cell Therapy

TABLE OF CONTENTS

1. Overview
1.1 Statement of Report
1.2 Scope of this Report
1.3 Methodology
1.4 Executive Summary

2. Regenerative Medicines: An Overview of Segments
2.1 Tissue Engineering
2.1.1 Tissue-Engineered Skin
2.1.2 Tissue-Engineered Cartilage
2.1.3 Tissue-Engineered Bone
2.1.4 Tissue-Engineered Peripheral Nerves
2.1.5 Tissue-Engineered Cornea
2.1.6 Tissue-Engineered Blood Vessels
2.1.7 Progress and Promises for Tissue Engineering Industry
2.1.7.1 Key Positioning Strategies in Tissue Engineering Industry
2.1.7.2 Tissue Engineering Industry Participants
2.1.7.3 Tissue Engineering Firms by their Product Applications
2.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products
2.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products
2.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products
2.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney
2.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products
2.1.7.9 Tissue Engineering Firms Involved in Dental Products
2.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products
2.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets
2.2 Cell Therapy
2.2.1 Progress in Cell Therapy Product Research
2.2.2 Commercially Available Cell Therapy Products
2.2.3 Major Cell Therapy Companies
2.2.4 Locations of Cell Therapy Companies
2.2.5 Disease Focus by Cell Therapy
2.2.6 Cell Therapy Products and Companies
2.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc.
2.2.7 Potential Patients for Cell Therapy in the U.S.
2.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy
2.2.9 Cell Therapy Pipeline
2.2.10 Cell Therapy Clinical Trials by Indication
2.2.10.1 Major Cell Therapy Clinical Trials for Diabetes
2.2.10.2 Progress in Clinical Trials for Diabetes
2.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes
2.2.11 Major Four Targeted Disease Conditions for Clinical Trials
2.2.12 Commercial Success of Cell Therapies in Europe
2.2.13 Deals in Cell Therapy, 2007-2011
2.2.14 Commercial-Stage Cell Therapy Companies and Products
2.2.15 Cell Therapy Clinical Trials in the U.K.
2.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the U.K.
2.2.15.2 Cell Types Involved in the U.K. Clinical Trials
2.2.15.3 U.K. Cell Therapy Clinical Trials by Indication
2.3 Cell Culture Products
2.3.1 Market for Reagents Used in Cell Culture
2.3.2 Cell Culture Media
2.3.3 Market for Sera Used in Cell Culture
2.3.3.1 Suppliers of Culture Media and Reagents
2.3.3.2 In Vitro Test Kits
2.3.3.3 Suppliers of Cells and Tissues
2.3.3.4 Equipment for Stem Cell Research
2.3.3.5 Computer Software for Stem Cell Research
2.4 Scaffolding Biomaterials
2.5 Growth Factors

3. Regenerative Medicine: The Next Evolution of Medical Treatment
3.1 Scope of this Chapter
3.2 Need for Regenerative Medicine
3.3 Current State of Regenerative Medicines
3.4 Future of Regenerative Medicine
3.4.1 Number of Products in Pipeline
3.5 Projected Timeline for Regenerative Medicine
3.6 Selected Regenerative Medicine Products in the Market
3.6.1 Medtronic?s Infuse Bone Graft and LT-Cage Device
3.6.2 Genzyme?s Corticel
3.6.3 OP-1 from Stryker
3.6.4 Osteocel from Osyris/Nuvasive
3.6.5 Spinal Implants from RTI Biologics
3.6.6 Apligraf from Organogenesis
3.6.7 Dermograft from Advanced BioHealing
3.6.8 Integra?s Bilayer Matrix for Wound Dressing
3.6.9 Alloderm from LifeCell
3.6.10 Celution from Cytori Therapeutics
3.6.11 Other Products of Importance in Regenerative Medicine
3.6.12 Tissue-Engineered Wound Healing Products
3.6.12.1 Oasis
3.6.12.2 Permacol
3.6.12.3 EZ-Derm
3.6.12.4 Matriderm
3.6.12.5 TransCyte
3.6.12.6 ICX-SKN
3.6.12.7 OrCel
3.6.12.8 Epicel
3.6.12.9 Myskin
3.6.12.10 VCT01
3.6.13 ICX-TRC?Hair Regeneration Therapy
3.6.14 Cartilage Regeneration
3.6.14.1 Novocart
3.6.14.2 BioSeed-C
3.6.14.3 BioSeed?Oral Bone
3.6.14.4 Chondrotissue
3.6.14.5 co.don Chondrotransplant
3.6.14.6 co.don Chondrotransplant DISC
3.6.14.7 co.don Chondrosphere
3.6.14.8 co.don Osteotransplant DENT
3.6.14.9 MACI Implant
3.6.14.10 Cartilink-3
3.6.14.11 Accell Evo3 Demineralized Bone Matrix
3.6.14.12 OsSatura BCP
3.6.15 Mozobil
3.7 Clinical Milestones in RM Sector, 2011-2012
3.7.1 GINTUIT (March 2012)
3.7.2 Ixmyelocel-T (February 2012)
3.7.3 Autologous CD34+ Stem Cells (February 2012)
3.7.4 HuCNS-SC (February 2012)
3.7.5 DeNovo ET (February 2012)
3.7.6 Retinal Pigment Epithelium Cells (January 2012)
3.7.7 AMR-001 (January 2012)
3.7.8 Avance Nerve Graft (January 2012)
3.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia (January 2012)
3.7.10 T-Cells Resistant to HIV (January 2012)
3.7.11 Tissue-Engineered Windpipe (November 2011)
3.7.12 Revascor (November 2011)
3.7.13 ReN001 Stem Cell Therapy (September 2011)
3.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers (August 2011)
3.7.15 ALD-301 for Critical Limb Ischemia (May 2011)
3.7.16 JVS-100 for Heart Failure (April 2011)
3.7.17 MultiStem for Ulcerative Colitis (March 2011)
3.7.18 HuCNS-SC Human Neural Stem Cells (March 2011)
3.8 Accelerated Pace of Deals in RM Sector
3.8.1 Acquisitions and Partnerships
3.8.1.1 Shire?s Acquisition of Advanced BioHealing, Inc. (May 2011)
3.8.1.2 Terumo Americas Holding?s Acquisition of Harvest Technologies (April 2011)
3.8.1.3 Sanofi?s Acquisition of Genzyme Corporation (February 2011)
3.8.1.4 NeoStem?s Acquisition of Progenitor Cell Therapy, LLC (January 2011)
3.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. (December 2011)
3.8.2 Notable Financings
3.8.2.1 Financing to AlloCure, Inc. (April 2012)
3.8.2.2 Financing to Promethera Biosciences (March 2012)
3.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. (February 2012)
3.8.2.4 Financing to Organovo (March 2012)
3.8.2.5 Financing to Cytomedix, Inc. (February 2012)
3.8.2.6 Financing to Fate Therapeutics, Inc. (May 2011)
3.8.2.7 Financing to Cellular Dynamics International, Inc. (April 2011)
3.8.2.8 Financing to Cytori Therapeutics (December 2010)
3.8.2.9 Overview of Capital Formation in RM Industry

4. Recent Advances in Regenerative Medicine and Stem Cell Research
4.1 Bioengineered Autologous Vein
4.2 Stem Cell Treatment for Spinal Cord Injury
4.3 Repairing Damaged Retina
4.4 A Possible Cure for Deafness
4.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc.
4.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem Cells
4.6.1 Recent Developments in Stem Cell Therapy in Cardiology
4.6.2 Recent Developments in Acute MI
4.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure
4.6.4 Stem Cells and Neurodegenerative Diseases
4.7 Disease Modeling: The Use of Inducible Cells
4.7.1 Modeling Disease with iPS Cells
4.7.2 Modeling Disease with Direct Neuronal Conversion
4.8 Stem Cell Transplants
4.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies
4.8.2 Stem Cell Types for Eye Disease Clinical Trials
4.8.2.1 Pluripotent Stem Cells
4.8.2.2 Neural Stem Cells
4.8.2.3 RPE Stem Cells
4.8.2.4 Limbal Stem Cells
4.8.2.5 Umbilical Cord Stem Cells
4.8.2.6 Bone Marrow Stem Cells
4.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration
4.8.2.8 Patch of hESC-Derived RPE Monolayer
4.8.2.9 Patient-Derived RPE
4.8.2.10 NSCs for AMD
4.8.2.11 UCSCs for RP and AMD
4.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases
4.8.2.13 Corneal Repair
4.8.2.14 Bioengineered Eye Tissues
4.9 Regenerative Strategies in the Treatment of Diabetes
4.9.1 Cell-Based Therapy for Diabetes
4.9.2 Embryonic Stem Cells and Induced Pluripotent Cells

5. Stem Cell Industry Highlights, 2012
5.1 Business Development
5.2 Clinical Trials
5.3 Market Authorization
5.4 Regulations
5.5 Capital Market and Finances
5.6 Investments in Xeno-Cell Therapy
5.7 Collaborations in Stem Cell Science
5.7.1 California Institute for Regenerative Medicine (CIRM)
5.7.2 The International Translational Regenerative Medicine Center

6. Regenerative Medicines: A Brief Update from Selected Countries
6.1 U.S.
6.1.1 Key Institutions
6.1.1.1 California Institute for Regenerative Medicine
6.1.1.2 The New York Stem Cell Foundation
6.1.1.3 NIH Center for Regenerative Medicine
6.1.2 Innovative Company
6.1.2.1 Aastrom Biosciences
6.2 Canada
6.2.1 Key Institutions
6.2.1.1 Institute of Biomaterials & Biomedical Engineering, University of Toronto
6.2.1.2 Terry Fox Research Institute
6.2.1.3 Institute for Research in Immunology and Cancer, University of Montreal
6.2.2 Innovative Companies
6.2.2.1 Northern Therapeutics
6.2.2.2 Octane Biotech
6.3 U.K.
6.3.1 Key Institutions
6.3.1.1 Loughborough University
6.3.1.2 U.K. Stem Cell Foundation
6.3.1.3 University College, London
6.3.2 Innovative Companies
6.3.2.1 Intercytex
6.3.2.2 Azellon Cell Therapeutics
6.3.2.3 Cell Medica
6.4 Sweden
6.4.1 Key Institutions
6.4.1.1 Karolinska Institutet
6.4.1.2 The University of Lund
6.4.2 Innovative Companies
6.4.2.1 Vitrolife
6.4.2.2 Cellartis
6.4.2.3 Biolamina
6.5 Brazil
6.5.1 Key Institutions
6.5.1.1 Universidade de SaoPaulo
6.5.1.2 Fiocruz and Hospital Sao Rafael
6.5.1.3 Universidade Federal do Rio de Janeiro
6.5.1.4 Pontificia Universidade Catolica do Parana
6.5.2 Innovative Company
6.5.2.1 Excellion & CellPraxys

7. Market Analysis for Regenerative Medicine Sector
7.1 Scope of this Chapter
7.2 Opportunities for RM Products
7.3 Commercial RM Products
7.3.1 Leading Commercial Cell Therapy Products
7.3.2 FDA Approved Cell-Based Products
7.3.3 Growth Spurt by Regenerative Medicine (RM)
7.4 Global Market for Tissue-Engineered Products
7.4.1 Tissue Engineering and Stem Cell Industry
7.5 Market for Stem Cell Therapy in Cardiology
7.6 Market for RM Products in Orthopedics
7.6.1 No Strong Alternatives for Medtronic?s INFUSE
7.6.2 Demineralized Bone Matrix (DBM)
7.6.3 The Unproven Stem Cells in Orthopedics
7.6.4 Future of Bone Replacement Market
7.7 Global RM Market for Neurology Products
7.8 Market for RM Dental Products
7.9 Market for RM Cancer Products
7.10 RM Market for Urology Products
7.11 Global Market for Skin Products
7.12 Overall Global RM Market
7.13 U.S. Market for Tissue-Engineered Skin
7.14 U.S. RM Market for Orthopedic/Spine Products
7.15 U.S. RM Market for Nerve Repair Products
7.16 U.S. RM Market for Cardiovascular and Stroke Products
7.17 U.S. Market for Anti-Inflammatory RM Products
7.18 U.S. Market for RM Products in Diabetes
7.19 Overall U.S. Regenerative Medicine Market
7.19.1 U.S. RM Market by Segment

8. Stem Cell Industry
8.1 Global Market for Stem cells
8.2 Stem Cell Use in the U.S.
8.2.1 Autologous Stem Cell Use in the U.S.
8.2.2 U.S. Stem Cell Market Overview
8.2.2.1 Potential U.S. Population for Cell-Based Therapies
8.2.3 U.S. Market for Stem cells
8.3 European Market for Stem Cells
8.3.1 Autologous and Allogeneic Cell Therapy Companies in Europe
8.4 Asia-Pacific Market for Stem Cells
8.5 Autologous Cell Therapy
8.5.1 Commercially Available Autologous Treatments
8.5.1.1 Autologous Cell Therapy for Alzheimer?s disease
8.5.1.2 Autologous Cell Therapy for Multiple Sclerosis
8.5.1.3 Autologous Cell Therapy for Wound Healing
8.5.1.4 Autologous Therapy for Cosmetic Surgery

9. Business Models and Requirements for a Successful Regenerative Medicine Industry
9.1 Scope of this Chapter
9.2 Business Models in Regenerative Medicine
9.2.1 Current Model for Autologous Cell Therapies
9.2.2 Current Models for Allogeneic Cell Therapies
9.3 Key Factors for Successful Business Models for Cell Therapies
9.4 Requirements for Commercial Manufacturing of Cell Therapy Products
9.4.1 Elements of Commercial Manufacturing
9.4.1.1 Regulatory Requirements
9.4.1.2 Manufacturing Process Scale
9.4.1.3 In-House Manufacturing
9.4.1.4 Contract Manufacturing: Commercial and Academic

10. Company Profiles
10.1. Aastrom Biosciences, Inc.
10.1.1 Aastrom?s Cellular Therapy and Ixmyelocel-T
10.1.1.1 Advantages of Patient?s Bone Marrow and Ixmyelocel-T
10.1.2 Aastrom?s Clinical Trials
10.1.2.1 REVIVE-CLI
10.1.2.2 RESTORE-CLI
10.2 Advanced Cell Technology, Inc. (ACT)
10.2.1 ACT?s Human ES Cell Programs
10.2.2 ACT?s Human Embryonic Stem Cell Technologies
10.2.3 ACT?s Cell Therapy Research Program
10.2.3.1 Retinal Pigment Epithelium Program
10.2.3.2 Hemangioblast Program
10.2.3.3 Adult Stem Cell Program
10.2.4 ACT?s Intellectual Property
10.3 AlloCure, Inc.
10.3.1 AlloCure?s Technology
10.3.2 AlloCure?s Clinical Trials
10.3.2.1 Acute Kidney Injury
10.3.2.2 Epidemiological Study of AKI
10.3.2.3 Phase I Clinical Trial in AKI
10.3.2.4 Phase II Clinical Trial in AKI
10.4 Altrika Ltd.
10.4.1 Myskin
10.4.2 Cryoskin
10.5 American Type Culture Collection, Inc. (ATCC)
10.5.1 ATCC?s Cell Lines and Hybridomas
10.5.2 ATCC?s Media, Sera and Reagents
10.5.3 MTT Cell Proliferation Assay
10.5.4 XTT Cell Proliferation Assay Kit
10.5.5 Universal Mycoplasma Detection Kit
10.5.6 DNA and RNA
10.5.7 STR Profile Database
10.5.8 hTERT Immortalized Cell Lines
10.5.9 Embryonic Stem Cell Products
10.5.10 Bacteria and Phages
10.5.11 Fungi and Yeast
10.5.12 Protozoa and Algae
10.5.13 Viruses and Related Reagents
10.5.14 Microbial DNA and RNA
10.5.15 ATCC?s Tissue Biology Products
10.6 Avita Medical Limited
10.6.1 ReCell
10.7 Amorcyte, LLC
10.7.1 AMR-001
10.8 Ars Arthro AS
10.8.1 CaReS
10.8.2 Fibrocell
10.8.3 Fibroplus
10.9 Axiogenesis AG
10.9.1 Human iPS Cell-Derived Cardiomyocytes
10.9.2 Murine Cardiomyocytes ES
10.9.3 Murine Cardiomyocytes iPS
10.9.4 Murine Endothelial Cells
10.9.5 Murine Smooth Muscle Cells
10.10 AxoGen, Inc.
10.10.1 Avance Nerve Graft
10.10.2 AxoGuard Nerve Protector
10.10.3 AxoGuard Nerve Connector
10.11 Bellicum Pharmaceuticals, Inc.
10.11.1 Bellicum?s Technology
10.11.2 Bellicum?s Pipeline
10.12 BetaStem Therapeutics, Inc.
10.12.1 BetaStem?s Technology
10.13 Bioheart, Inc.
10.13.1 MyoCell
10.13.2 MyoCell SDF-1
10.13.3 MyoCath
10.13.4 LipiCell
10.14 Biomet, Inc.
10.14.1 Endobon Xenograft Granules
10.14.2 RegenerOss Allograft
10.14.3 Ground Cancellous Bone
10.15 BioMimetic Therapeutics, Inc.
10.15.1 Augment Bone Graft
10.15.2 Augmatrix Biocomposite Bone Graft
10.16 BioTissue Technologies AG
10.16.1 BioSeed-C
10.16.2 Chondrotissue
10.16.3 BioSeed-Oral Bone
10.17 Biovest International, Inc.
10.17.1 Autovaxid
10.17.2 Xcellerator
10.17.3 Maximizer
10.17.4 Minimax
10.18 BrainStorm Cell Therapeutics, Inc.
10.18.1 NurOwn
10.19 California Stem Cell, Inc.
10.19.1 Clinical Pipeline
10.19.1.1 MotorGraft
10.19.1.2 Cancer Stem Cell
10.19.2 Cell Products
10.19.2.1 MotorPlate and MotorVial
10.19.2.2 NeuroPlate and NeuroVial
10.19.2.3 OPCVial
10.19.2.4 HepatoPlate
10.19.3 Cell Culture Products
10.19.3.1 StemBlast
10.19.3.2 MotorBlast
10.19.3.3 NeuroBlast
10.19.3.4 OPC Media
10.19.3.5 Cellular Transplant Solution
10.20 Cardio3 Biosciences SA
10.20.1 Products Pipeline
10.20.1.1 C3BS-CQR-1 (C-Cure)
10.20.1.2 Positive Phase II Results for C-Cure
10.20.1.3 C3BS-CQR-1 (Protein)
10.20.1.4 C-CATHez (Medical Device)
10.21 Cellartis AB (Cellectis)
10.21.1 iPS Engineering Hub
10.21.2 Hepatocytes hiPS-HEP
10.21.3 Cardiomyocyte Clusters hES-CMC
10.21.4 Stem Cell Culture System DEF-CS
10.22 CellSeed, Inc.
10.22.1 Epithelial Cell Sheet for Corneal Regeneration
10.22.2 Regenerated Cardiac Patch
10.22.3 Epithelial Cell Sheet for Esophageal Regeneration
10.22.4 Cell Sheet for Periodontal Regeneration
10.22.5 Regenerated Cartilage Sheet
10.23 Cellular Dynamics International, Inc.
10.23.1 iCell Cardiomyocytes
10.23.2 iCell Endometrial Cells
10.23.3 iCell Hepatocytes
10.23.4 iCell Neurons
10.23.5 MyCell Products
10.24 Chromocell Corporation
10.24.1 Chromovert Technology
10.24.2 Chromovert Applications
10.24.2.1 Pain Relief
10.24.2.2 Anxiety Treatments
10.24.2.3 Respiratory Disorders
10.25 Cognate Bioservices, Inc.
10.25.1 Process Development
10.25.2 Regulatory Services
10.25.3 Assay Development
10.25.4 Preclinical Services
10.25.5 Stem Cell Services
10.26 Cook Biotech, Inc.
10.26.1 Cook?s Technology
10.26.2 Biodesign Dural Graft
10.26.3 Dynamatrix Extracellular Membrane
10.26.4 tarSys
10.26.5 Oasis Wound Matrix
10.26.6 Biodesign Staple Line Reinforcement
10.26.7 Biodesign Hiatal Hernia Graft
10.26.8 CorMatrix ECM
10.26.9 ECM for Cardiac Tissue Repair
10.26.10 Biodesign Incision Graft
10.26.11 Biodesign Inguinal Hernia Graft
10.26.12 Biodesign Parastomal Reinforcement Graft
10.26.13 Biodesign Umbilical Hernia Graft
10.26.14 Biodesign Anterior Pelvic Floor Graft
10.26.15 Biodesign Fistula Plug
10.26.16 LIFT with Biodesign
10.26.17 Biodesign Posterior Pelvic Floor Graft
10.26.18 Biodesign Peyronie?s Repair Graft
10.26.19 Biodesign Tension-Free Urethral Sling
10.27 Cytomedix, Inc.
10.27.1 Cytomedix?s AutoloGel System
10.27.1.1 The Working of AutoloGel System
10.27.1.2 Balancing Effect of AutoloGel System
10.27.1.3 Formulation of AutoloGel System
10.27.2 Cytomedix?s Angel PRP
10.28 Cytonet, LLC
10.28.1 Cytonet?s Liver Cell Therapy
10.28.2 SELICA III Clinical Trial
10.29 Cytori Therapeutics, Inc.
10.29.1 Cytori?s Commercial Activities and Markets
10.29.2 Cytori?s Pipeline
10.29.2.1 Celution System for Cardiovascular Disease
10.29.2.2 Other Applications of Celution System
10.29.2.3 PureGraft
10.29.2.4 StemSource
10.30 DanDrit Biotech A/S
10.30.1 Dendritic Cell
10.30.1.2 Colorectal Cancer Trial Phase II in Singapore
10.30.1.3 Non-Small-Cell Lung Cancer, Phase II
10.31 Fibrocell Science, Inc.
10.31.1 Fibrocell?s Technology
10.31.2 Pipeline
10.32 Forticell Bioscience, Inc.
10.32.1 OrCel
10.33 Gamida Cell Ltd.
10.33.1 Gamida?s Technology
10.33.1.1 Copper Chelator Based Technology
10.33.1.2 NAM Based Technology
10.33.1.3 StemEx
10.33.1.4 NiCord
10.33.1.5 CordBridge
10.33.1.6 NK Cell Product
10.34 Harvest Technologies Corporation
10.34.1 Smart PReP2 APC+
10.34.2 SmartPReP 2 BMAC
10.35 Histogenics Corporation
10.35.1 NeoCart
10.35.2 VeriCart
10.36 Humacyte, Inc.
10.36.1 Humacyte Grafts
10.37 Integra Lifesciences Holdings Corporation
10.37.1 Integra?s Products Overview
10.37.2 Integra?s Orthopedics Product Portfolio
10.37.3 Integra?s Extremity Reconstruction Product Portfolio
10.37.3.1 Skin and Wound
10.37.3.2 Bone and Joint Fixation Devices and Instruments
10.37.3.3 Lower Extremity Products
10.37.3.4 Upper Extremity Products
10.37.3.5 Bone Graft Substitutes for Extremity Reconstruction
10.37.3.6 Nerve and Tendon
10.37.4 Integra?s Spine Product Portfolio
10.37.4.1 Integrated Interbody Fusion Devices
10.37.4.2 Minimally Invasive Solutions
10.37.4.3 Deformity Correction
10.37.4.4 Orthobiologics
10.37.4.5 Integra?s Research and Development in Regenerative Medicine
10.38 Intercytex Ltd.
10.38.1 VAVELTA
10.38.2 Epidermolysis Bullosa
10.38.3 Scar Contractures
10.38.4 Acne Scarring
10.38.5 International Stem Cell Corporation
10.38.6 Therapeutic Programs
10.39 iPierian, Inc.
10.39.1 Technology
10.39.2 Product Development
10.40 Japan Tissue Engineering Co., Ltd.
10.40.1 Autologous Cultured Epidermis
10.40.2 Autologous Cultured Cartilage
10.40.3 Autologous Cultured Corneal Epithelium
10.41 Kensey Nash Corporation
10.41.1 Medeor Matrix
10.41.2 Meso BioMatrix Scaffold
10.41.3 Epi-Guide Bioresorbable Barrier Matrix
10.41.4 OsseoFit Porous Tissue Matrix
10.41.5 Vitoss Scaffold Foam Products
10.42 Kiadis Pharma B.V.
10.42.1 Kiadis? Pipeline
10.42.1.1 ATIR
10.42.1.2 Reviroc
10.42.1.3 Rhitol
10.43 Living Cell Technologies Limited (LCT)
10.43.1 Diabecell
10.43.2 Ntcell
10.44 Life Cell Corporation
10.44.1 AlloDerm
10.44.2 Cymetra Micronized AlloDerm Tissue
10.44.3 Strattice Reconstructive Tissue Matrix
10.44.4 SPY Elite System
10.45 MaxCyte, Inc.
10.45.1 MaxCytes Technology Platform
10.45.2 Drug Discovery Applications
10.45.2.1 GPCRs
10.45.2.2 Ion Channels
10.45.3 Antibody Production
10.45.4 General Protein Production
10.45.5 Viral Vector and VLP Production
10.45.6 Insect Cell Transfection
10.45.7 Cell Therapy
10.45.7.1 Dendritic Cell Vaccines
10.45.7.2 Regenerative Medicine
10.45.7.3 Chimeric Antigen Receptor (CAR) Immunotherapy
10.46 MediStem, Inc.
10.46.1 Intellectual Property
10.46.1.1 Method for Expansion of Stem Cells
10.46.1.2 Compositions of Placentally-Derived Stem Cells for the Treatment of Cancer
10.46.1.3 Transcatheter Tumor Immunoembolization
10.46.1.4 Stem Cell Therapy for Cardiac Valvular Dysfunction
10.46.1.5 Treatment of Erectile Dysfunction by Stem Cell Therapy
10.46.1.6 Allogeneic Stem Cell Transplants in Non-Conditioned Recipients
10.46.1.7 Stem Cell Mediated Treg Activation for Therapeutic Immune Modulation
10.46.1.8 Cellular Therapy for Lower Back Pain
10.46.1.9 Compositions and Methods of Stem Cell Therapy for Autism
10.46.1.10 Stem Cell Therapy for Weight Loss
10.46.1.11 Menstrual Blood Cellular Populations, Isolation, and Use Thereof
10.46.1.12 Endometrial Derived Reparative/Regenerative Cells
10.46.1.13 Treatment of Insulin Resistance and Diabetes
10.46.1.14 Combination Treatment of Cardiovascular Disease
10.46.1.15 Stem Cell Therapy for Autism
10.46.2 Product Pipeline
10.46.2.1 Endometrial Regenerative Cell Platform
10.46.2.2 Angiostem Platform
10.46.2.3 Tolerostem Platform
10.47 Mesoblast Ltd.
10.47.1 Revascor
10.47.2 MPCs for Diabetics
10.47.3 Bone Marrow Derived Allogeneic MPCs
10.47.4 Macular Degeneration
10.47.5 Diabetic Macular Edema
10.47.6 Intervertebral Disc Repair Product
10.47.7 Lumbar and Cervical Spinal Fusion Product
10.47.8 Fracture Repair Product
10.47.9 Arthritis Product
10.48 MolMed S.p.A.
10.48.1 MolMed?s Technological Platforms
10.49 NanoCor Therapeutics, Inc.
10.49.1 Carfostin
10.50 Neuralstem, Inc.
10.50.1 Neuralstem?s Technology Platforms: Stem Cells
10.50.2 Pharmaceutical Compounds
10.50.3 Neuralstem?s Clinical Trials for Stem Cells
10.50.4 Clinical Trials for Neuralstem?s Pharmaceutical Compound
10.51 NeuroNova AB
10.51.1 Neurogenesis Qualifier
10.51.2 NeuroNova?s Projects
10.52 Olympus Terumo Biomaterials Corp.
10.52.1 OSferion60
10.52.2 Terudermis
10.52.3 OSferion
10.52.4 Teruplug
10.52.5 Bone Cream
10.53 NewLink Genetics Corporation
10.54 OncoMed Pharmaceuticals, Inc.
10.54.1 OncoMed?s Research on Cancer Stem Cells
10.54.2 OncoMed?s Platform
10.54.3 OncoMed?s Development Pipeline
10.55 Opexa Therapeutics, Inc.
10.55.1 T-Cell Platform
10.56 Organogenesis, Inc.
10.56.1 Apligraf
10.56.2 Gintuit
10.57 Orthovita, Inc.
10.57.1 Vitoss
10.58 Osiris Therapeutics, Inc.
10.58.1 Osiris? Technologies
10.58.1.1 Stem Cell Source
10.58.1.2 Manufacturing Process
10.59 Osteotech, Inc.
10.59.1 MagniFuse
10.59.2 Plexur P
10.59.3 Plexur M
10.59.4 FacetLinx Fusion Technology
10.59.5 Grafton
10.59.6 Xpanse Bone Inserts
10.59.7 GraftCage TLX and GraftCage ACX
10.60 Pervasis Therapeutics, Inc.
10.61 Pluristem Therapeutics, Inc.
10.62 Proneuron Biotechnologies, Inc.
10.62.1 Spinal Cord Technology
10.63 RegeneRx
10.63.1 T?4 Peptide Research
10.64 ReNeuron Group PLC
10.64.1 ReN001
10.64.2 ReN009
10.64.3 ReNcell VM and ReNcell CX
10.65 Revivicor, Inc.
10.65.1 Xenotransplantation Technology
10.66 SanBio, Inc.
10.66.1 SanBio?s Product Pipeline
10.66.1.1 SB623
10.66.1.2 SB618
10.66.1.3 SB308
10.67 Saneron CCEL Therapeutics, Inc.
10.67.1 U-Cord Cell Program
10.67.2 Sert-Cell Program
10.68 Sangamo Biosciences, Inc.
10.68.1 SB-728
10.68.2 SB-313
10.68.3 Hemophilia
10.69 Stem Cell Authority Ltd.
10.69.1 MIRACHYMAL Stem Cells
10.70 StemCells, Inc.
10.70.1 StemCells? Research Collaborations
10.70.1.1 Stanford University and Stanford School of Medicine
10.70.1.2 UC Irvine
10.70.1.3 OHSU Casey Eye Institute
10.70.1.4 McLaughlin Research Institute
10.70.2 StemCells? Therapeutic Programs
10.70.3 Cells and Cell Lines
10.70.4 Cell Culture Products
10.70.5 Antibody Detection Reagents
10.70.6 Purified Whole Stem Cell Lysates
10.71 Stemline Therapeutics, Inc.
10.71.1 Cancer Stem Cells
10.71.2 Stemline Therapeutics? Platform
10.72 Stratetech Corporation
10.72.1 Stratatech?s Core Technology
10.73 Synthecon, Inc.
10.73.1 Rotary Cell Culture Systems
10.73.2 Biofelt (Bioabsorbable Scaffold)
10.73.3 Biomerix 3D Scaffolds
10.73.4 RollerCell 40
10.74 Tengion, Inc.
10.74.1 Tengion?s Scientific Platform
10.74.2 Tengion?s Pipeline
10.75 TiGenics NV
10.75.1 ChondroCelect
10.75.2 CX601
10.75.3 Cx611
10.75.4 Cx621
10.76 Tissue Genesis, Inc.
10.76.1 Clinical Therapies from Tissue Genesis
10.76.1.1 Icellator
10.76.1.2 Adipase
10.77 Thermogenesis Corp.
10.77.1 AXP System
10.77.2 MXP System
10.77.3 Manual Systems
10.77.4 Res-Q 60 BMC System
10.77.5 BioArchive System
10.78 ViaCyte, Inc.
10.78.1 Technology Overview
10.79 Vistagen Therapeutics, Inc.
10.79.1 Vistagen?s Technology
10.79.2 CardioSafe 3D
10.79.3 LiverSafe 3D
10.80 Zen-Bio, Inc.

Appendix 1: Allogeneic vs. Autologous Stem Cell Therapy
Appendix 1.1: Manufacturing Process
Appendix 1.2: Cost Differential
Appendix 1.3: Donor Screening and Testing
Appendix 1.4: Release Testing
Appendix 1.5: Overall Analysis


INDEX OF FIGURES

Figure 2.1: Geographic Distribution of Tissue Engineering Firms in Major Markets
Figure 2.2: The Potential Uses of Embryonic Stem Cells
Figure 2.3: Progress of Cell Therapy Product Research, 2012
Figure 2.4: Commercially Available Cell Therapy Products, 2012
Figure 2.5: Disease Focus by Regenerative Medicine
Figure 2.6: Estimated Completion Dates for Stem Cell Based Clinical Trials Targeting Type 1 Diabetes,2009-2015
Figure 2.7: Number of Clinical Trials by Targeted Condition, 2005-2011
Figure 2.8: Concentration of European Cell Therapy Firms, 2012
Figure 2.9: European Stem Cell Platforms by Cell Source
Figure 2.10: Autologous vs. Allogeneic Stem Cell Therapy Firms in Europe, 2012
Figure 2.11: Autologous and Allogeneic Somatic Cell Therapy Firms in Europe, 2012
Figure 2.12: Sponsors of Cell Therapy Clinical Trials in the U.K., 2012
Figure 2.13: Clinical Trials Involving Allogeneic vs. Autologous Cell Therapy Products in the U.K., 2012
Figure 2.14: Cell Types Involved in the U.K. Cell Therapy Clinical Trials, 2012
Figure 2.15: U.K. Cell Therapy Clinical Trials by Indication, 2012
Figure 2.16: Cell Culture Products Market by Segment, 2012
Figure 2.17: Market for Reagents Used in Cell Culture, 2012-2019
Figure 2.18: Market for Media Used in Cell Culture, 2012-2019
Figure 2.19: Market for Serum Used in Cell Culture, 2012-2019
Figure 5.1: CIRM?s Grants for Disease Types by Funding Level, 2012
Figure 7.1: Commercially Available Regenerative Products
Figure 7.2: Global Market for Tissue Engineering Products, 2012-2019
Figure 7.3: Global RM Market for Cardiology and Vascular Products, 2012-2019
Figure 7.4: Alternatives for Medtronic?s Infuse
Figure 7.5: Global Market for RM Products in Orthopedics, Musculoskeletal and Spine, 2012-2019
Figure 7.6: Global RM Market for Neurology Products, 2012-2019
Figure 7.7: Global RM Market for Dental Products, 2012-2019
Figure 7.8: Global Tissue Engineering and Cell Therapy Market for Cancer Products, 2012-2019
Figure 7.9: Global Market for RM Products in Urology, 2012-2019
Figure 7.10: Global Market for RM Products in Skin/Integument, 2012-2019
Figure 7.11: Global Tissue Engineering and Cell Therapy Market, 2012-2019
Figure 7.12: U.S. Market for Tissue Engineered Skin Replacement and Substitutes, 2012-2019
Figure 7.13: U.S. Market for RM Products in Orthopedic/Spine, 2012-2020
Figure 7.14: U.S. Market for RM Products in Nerve Repair, 2012-2020
Figure 7.15: U.S. Market for RM Products in Cardiovascular Therapies, 2012-2020
Figure 7.16: U.S. Market for RM Products in Anti-Inflammatory Therapies, 2012-2020
Figure 7.17: U.S. Market for RM Products in Diabetes, 2012-2020
Figure 7.18: U.S. Market for Regenerative Medicines, 2012-2020
Figure 7.19: U.S. Regenerative Medicine Market by Segment, 2020
Figure 8.1: Global Market for Stem Cell Products, 2012-2020
Figure 8.2: U.S. Market for Stem Cell Products, 2012-2020
Figure 8.3: Estimated U.S. Market for Stem Cell Therapy by Type, 2020
Figure 8.4: European Market for Stem Cell Products, 2012-2020
Figure 8.5: Number of Autologous and Allogeneic Cell Therapy Firms in Europe
Figure 8.6: Asia-Pacific Market for Stem Cells, 2012-2019
Figure 8.7: Global Autologous Cell Therapy Market, 2012-2019
Figure 9.1: Cell-Based Business Models
Figure 9.2: Current Autologous Business Models
Figure 9.3: Current Allogeneic Business Models
Figure 10.1: Aastrom?s Cell Expansion Process


INDEX OF TABLES

Table 2.1: Commercially Available Bioengineered Skin Products
Table 2.2: A Partial List of Companies Offering Bioreactor Systems
Table 2.3: Number of Tissue Engineering Companies in the Five Focus Countries
Table 2.4: Number of Tissue Engineering Firms Developing Stem Cells Seeded to Scaffolds
Table 2.5: Number of Tissue Engineering Firms Focusing on Skin, Cartilage, Bone and Urological Products
Table 2.6: Number of Tissue Engineering Firms Focused on Cardiovascular Products
Table 2.7: Number of Tissue Engineering Firms Focusing on Neurological Products
Table 2.8: Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney
Table 2.9: Number of TE Firms Focused on Autologous and Allogenic Products
Table 2.10: Major Cell Therapy Companies
Table 2.11: Geographical Distribution of Cell Therapy Companies
Table 2.12: Cell Therapy Products on the Market
Table 2.13: Cell Therapy Products on the Market by Type and Application
Table 2.14: Potential Patients for Cell Therapy in the U.S.
Table 2.15: Number of Patients Treated with Cell Therapy Between 1988 and 2010
Table 2.16: Cell Therapy Pipeline, 2005-2011
Table 2.17: Number of Stem Cell Clinical Trials by Indication, 2012
Table 2.18: Major Cell Therapy Clinical Trials for Diabetes and Estimated Enrollment Targets, 2012
Table 2.19: Progress in Clinical Trials for Diabetes, 2012
Table 2.20: Cell Therapy Deals, 2007-2011
Table 2.21: Select Cell Therapy Products with FDA/EMA Regulatory Approval, 1998-2010
Table 2.22: Cell Therapy Companies and Products
Table 2.23: Cell Therapy Products Approved in South Korea
Table 2.24: Selected Suppliers of Culture Media and Reagents
Table 2.25: Selected Suppliers of In Vitro Test Kits
Table 2.26: Selected Suppliers of Cells and Tissues
Table 2.27: Selected Suppliers of Equipment for Stem Cell Research
Table 2.28: Selected Companies Offering Computer Software for Stem Cell Research
Table 3.1: Industry Participants in Regenerative Medicine
Table 3.2: Top Ten Regenerative Medicine Products in the Market
Table 3.3: Industry-Sponsored Active Cell Therapy Trials, 2007 and 2012
Table 4.1: Recently Published Stem Cell Therapy Clinical Trials for Ischemic Heart Disease
Table 5.1: CIRM Funding for Projects Moving Towards Disease Therapies, 2012
Table 5.2: List of CIRM Funded Institutions, 2012
Table 7.1: A Sampling of Leading Commercial Cell Therapy Products, 2012
Table 7.2: FDA-Approved Cell-Based Products, 1997-2012
Table 7.3: Ongoing and Reported Clinical Trials in Ischemic Heart Disease
Table 7.4: Human Skin Equivalents for Clinical Skin Replacements and Grafts
Table 7.5: Human Skin Models for Drug Permeability Tests and Toxicity Screening
Table 8.1: Cell Therapy Products Revenue, 2010-2011
Table 8.2: Market Capitalization of Public Stem Cell Companies, 2011 vs. 2010
Table 8.3: Potential U.S. Population for Cell-Based Therapies
Table 8.4: Non-Autologous and Autologous Skin Substitutes and Dermal Treatments for Other Applications
Table 9.1: The Required Elements of a Manufacturing Facility
Table 9.2: Cell Therapy CMO Qualification Audit: Points to Investigate
Table 10.1: ACT?s Pipeline of Therapeutic Programs
Table 10.2: Patents Owned by ACT
Table 10.3: Patents Owned by ACT?s Subsidiary Mytogen, Inc.
Table 10.4: Patents Licensed to ACT by the University of Massachusetts
Table 10.5: Bellicum?s Pipeline
Table 10.6: Bioheart's Intellectual Property
Table 10.7: Cardio3 Biosciences? Products Pipeline
Table 10.8: Gamida?s Pipeline Overview
Table 10.9: International Stem Cell Corporation?s Therapeutic Programs
Table 10.10: Kiadis? Pipeline
Table 10.11: MolMed?s Pipeline
Table 10.12: NeuroNova?s Projects
Table 10.13: NewLink?s Pipeline Overview
Table 10.14: OncoMed?s Development Pipeline
Table 10.15: Vitoss Bone Graft Substitutes
Table 10.16: Osiris? Product Pipeline
Table 10.17: Pervasis? Pipeline
Table 10.18: Pluristem?s Product Candidates Pipeline
Table 10.19: Proneuron?s Pipeline
Table 10.20: RegeneRx?s Pipeline/Clinical Trials
Table 10.21: RegeneRx?s T ? Peptide Research
Table 10.22: SanBio?s Product Pipeline
Table 10.23: Sangamo?s Product Pipeline
Table 10.24: StemCells? Broad Pipeline
Table 10.25: Stemline Therapeutics? Clinical Programs
Table 10.26: Stemline Therapeutics? Preclinical Programs
Table 10.27: Stratatech?s Product Pipeline
Table A1.1: Comparison of Autologous and Allogeneic Stem Cell Therapy
 
Companies Mentioned
- Aastrom Biosciences, Inc.
- Advanced Cell Technology, Inc. (ACT)
- Aldagen, Inc.
- Altrika Ltd.
- Alseres Pharmaceuticals, Inc.
- Amgen, Inc.
- Amorcyte, Inc.
- AnGes MG, Inc.
- Angioblast Systems, Inc.
- Angion Biomedica, Corp.
- Ars Arthro Biotechnology, Inc.
- Arteriocyte Medical Systems, Inc.
- Athersys, Inc.
- BeFutur Biotechnologies
- BioE, Inc.
- Bioheart, Inc.
- BioLine Rx
- BIOMET
- BioMimetic Therapeutics, Inc.
- BioSafe Group SA
- BioTime, Inc.
- Biovest International, Inc.
- BrainStorm Cell Therapeutics, Inc.
- Cardio BioSciences
- CardioPolymers, Inc.
- CardioPolymer's Products
- CaridianBCT
- Cardium Therapeutics, Inc.
- Cellartis' Products
- Cellerix
- Celgene Corporation
- CellSeed, Inc.
- Cellular Dynamics International
- Celltrix
- Cerco Medical
- Cook Biotech, Inc.
- Cord Blood America (CBAI), Inc.
- Cryo-Cell International, Inc.
- Curis, Inc.
- Cytori Therapeutics, Inc.
- Develogen AG
- Effector Cell Institute, Inc (ECI)
- Epistem plc
- FivePrime Therapeutics, Inc.
- Forticell Bioscience, Inc.
- Gamidia Cell Ltd.
- GeneGrafts Ltd.
- GenVec, Inc.
- Genzyme Corporation
- Geron Corporation
- Harvest Technologies Corporation
- HemaStem Therapeutics, Inc.
- HepaLife Technologies, Inc.
- Humacyte, Inc.
- Hydra Biosciences, Inc.
- Intercytex Group plc
- Integra Lifesciences Holdings Corporation
- International Stem Cell Corporation (ISCO)
- Japan Tissue Engineering, Co., Ltd.
- Karocell Tissue Engineering AB
- Kensey Nash Corporation
- Kiadis Pharma, BV
- LifeCell
- MaxCyte, Inc.
- Mesoblast Ltd.
- NanoCor's Products
- NeuralStem, Inc.
- NeuroNova AB
- Olympus Terumo Biomaterials Corporation
- Opexa Therapeutics, Inc.
- Organogenesis, Inc.
- Orthovita, Inc.
- Osiris Therapeutics, Inc.
- Osteotech, Inc.
- Pervasis Therapeutics, Inc.
- Pleuron's Technology
- Pluristem Therapeutics, Inc.
- RegeneRx
- ReNeuron Group plc
- Revivicor, Inc.
- Saneron CCEL Therapeutics, Inc.
- Sangamo BioSciences, Inc.
- StemCells, Inc.
- Stem Cell Innovations (SCI)
- Stem Cell Sciences KK
- SyntheMed, Inc.
- t cure GmbH
- Tengion
- TiGenix
- Thermogenesis Corp.
 
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