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Mesenchymal Stem Cells - Advances & Applications

  • ID: 3292443
  • July 2015
  • Region: Global
  • 171 Pages
  • BioInformant
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FEATURED COMPANIES

  • Anterogen Co., Ltd.
  • CellTherapies P/L
  • Cesca Therapeutics Inc.
  • Kite Pharma Inc.
  • Medipost Co. Ltd.
  • NuVasive Inc.
  • MORE

This global strategic report is produced for:

- Management of stem cell companies
- Management of regenerative therapy companies
- Stem cell industry investors

It is designed to increase your efficiency and effectiveness in:

1. Commercializing mesenchymal stem cell (MSC) products, technologies, and therapies
2. Making intelligent investment decisions
3. Launching high-demand products
4. Selling effectively to your client base
5. Increasing revenue from MSC products and services
6. Taking market share from your competition

Report Objectives

The purpose of this report is to describe the current status of mesenchymal stem cells (MSCs) research, the ongoing clinical trials involving MSCs, late stage MSCs clinical trials, and the possible uses of MSCs in cell therapy. As MSC cell therapy is an integrated component of other cell therapies and regenerative medicines (RM), the report also gives a brief overview of the RM industry and overall cell therapy (CT) industry.
Thus, the main objectives are to consider the following:
- Current status of global regenerative medicine (RM) industry in the utilization of stem cells in general READ MORE >

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Anterogen Co., Ltd.
  • CellTherapies P/L
  • Cesca Therapeutics Inc.
  • Kite Pharma Inc.
  • Medipost Co. Ltd.
  • NuVasive Inc.
  • MORE

1. REPORT OVERVIEW
1.1 Statement of the Report
1.2 EXECUTIVE SUMMARY
2. INTRODUCTION
2.1 Regenerative Medicine (RM) and Advanced Therapies Industry: A Brief Overview
2.10 Type of Financing for RM Industry
2.11 Major Regulatory Milestones in RM Industry
2.12 Major Data and Technology Events in RM Industry
2.13 Major Pharma and Biotech Companies Active in Advanced Therapies
2.14 Major Corporate Partnerships in RM Industry
2.15 Anticipated Major RM Clinical Events
2.16 Notable Deals and Acquisitions in RM, Cell and Gene Therapy Space, 2013-2014
2.17 Big Pharma’s Perception of RM
2.18.1 Major Therapeutic Opportunities for Big Pharma in Cell Therapy and RM
2.18.1.1 Current Opportunities
2.18.1.2 Near-Term Opportunities
2.18.1.3 Long-Term Opportunities
2.2 Global Breakdown of Major RM Industries by Region
2.3 Breakdown of Global RM Companies by Type
2.4 Number of Therapeutic Companies, Approved Products and Clinical Trials in RM Sector
2.5 Number of RM Clinical Trials by Phase of Development
2.6 Number of RM Companies by Disease Focus Area
2.7 Major Financial Events in RM Industry
2.8 Major Partnerships and Acquisitions in RM Industry
2.9 Total Financings in RM Industry by Segment
3. CELL THERAPY INDUSTRY: A BRIEF OVERVIEW
3.1 Types of Stem Cells Used in Cell Therapy
3.1.1 Human Embryonic Stem Cells (hESCs)
3.1.2 Induced Pluripotent Stem Cells (iPSCS)
3.1.3 Hematopoietic Stem Cells (HSCs)
3.1.4 Mesenchymal Stem Cells (MSCs)
3.1.5 Adipose Stem Cells (ASCs)
3.1.6 Neural Stem Cells (NSCs)
3.10 Combination of Cell and Gene Therapy Products in Development
3.11 Cancer Programs Utilizing the Combination of Cell and Immunotherapy
3.12 Major Commercially Available Cell Therapy Products
3.13 Cell Therapy Products Approved in South Korea
3.14 Cell Therapy Clinical Trials: An Overview
3.14.1 Cell Therapy Clinical Trials by Geography
3.14.2 Top Eight Countries in Cell Therapy Clinical Trials
3.14.3 Major Cell Types in Cell Therapy Clinical Trials
3.14.4 Major Disease Indications Addresses by Cell Therapy Clinical Trials
3.15 Fifteen Major Cell Therapies in Phase III
3.15.1 Prochymal
3.15.10 Renew
3.15.11 NT-501 (Renexus)
3.15.12 Neocart
3.15.13 DeNovo ET
3.15.14 MACI
3.15.2 Mesenchymal Precursor Cell (MPC)
3.15.3 MyoCell
3.15.4 Ixmyelocel-T
3.15.5 ELAD
3.15.6 HP802
3.15.7 StemEx (Carlecortemcel-L)
3.15.8 LaViv
3.15.9 GSK 2696273
3.16 Clinical Trial Failures in Cell Therapy in 2014
3.16.1 Failure of Phase II for MultiStem
3.16.10 Failed Efficacy Trial in AMI by Stempeucel
3.16.2 Failure of Cardio 133 Trial
3.16.3 Termination of AlloCure’s ACT-AKI Trial
3.16.4 Failed Stroke Trial in India
3.16.5 Failure of HeartiCellGram-AMI Trial
3.16.6 Failure of Adipose MSCs in ARDS
3.16.7 CD133+ in CLI Not Feasible
3.16.8 Failed MSC Trial for Multiple Sclerosis
3.16.9 Failure of Chinese Diabetes Trial
3.17 A Sampling of Stem and Progenitor Cell-Based Trials with 2014 Clinical Readouts
3.18 Major Cell Therapy Companies and their Locations
3.19 Involvement of Multinational Companies (MNCs) in Cell Therapy Sector
3.2 Cell Therapy Product Candidates in Late-Stage Clinical Development
3.3 Cell Therapy Product Candidates in Early-Stage Clinical Development
3.4 Cell Therapy Products Being Developed for Cardiovascular Indication
3.5 Cell Therapy Products Being Developed for Central Nervous System Indication
3.6 Cell Therapy Products Developed and Being Developed for Wound Care
3.7 Cell Therapy Products Developed and Being Developed for Spine and Orthopedics
3.8 Cell Therapy Products Being Developed for Diabetes
3.9 Cell Therapy Products Being Developed for Autoimmune Diseases
4. MESENCHYMAL STEM CELLS (MSCs): AN OVERVIEW
4.1 Biological Properties of MSCs Contributing to their Therapeutic Effects
4.1.1 MSCs’ Capacity to Migrate and Engraft
4.1.2 MSCs’ Differentiation Potential
4.1.3 MSCs’ Potential to Secrete Multiple Bioactive Molecules
4.1.4 MSCs’ Potential for Immunomodulatory Functions
4.1.5 Variable Immunophenotype of MSCs
4.2 Factors Impacting MSCs Acquisition
4.3 Major Clinical Sources of MSCs
4.3.1 Bone Marrow-Derived Mesenchymal Stem Cells (BMMSCs)
4.3.1.1 BMMSCs and Kidney
4.3.1.2 BMMSCs and Pancreas
4.3.1.3 BMMSCs and Heart
4.3.1.4 BMMSCs and Liver
4.3.1.5 BMMSCs and Brain
4.3.1.6 BMMSCs and Intestine
4.3.1.7 BMMSCs and Bone
4.3.2 Adipose-Derived Mesenchymal Stem Cells
4.3.2.1 Selected ADSC Secretomes and their Functions
4.3.3 Mesenchymal Stem Cells (MSCs) Derived from Wharton’s Jelly
4.3.3.1 Clinical Application Properties of WJ-MSCs
4.3.3.2 Immunoprivileged Status of WJ-MSCs
4.3.3.3 Clinical Applications of WJ-MSCs
4.3.4 Umbilical Cord Blood-Derived MSCs (UCBMSCs)
4.4 Dominance of MSCs in Cell Therapy Clinical Trials
4.5 Major Diseases Addressed by MSCs in Current Clinical Trials
4.5.1 MSCs for Treating Liver Diseases
4.5.10 MSCs in Wound Healing
4.5.11 Increasing Focus on Immunological Properties of MSCs
4.5.12 Percentage of MSCs Clinical Trials by Different Phases
4.5.13 Selected MSCs Late-Stage Pipeline Cell Therapies
4.5.2 MSCs for Neurodegenerative Diseases
4.5.3 Clinical Trials Using MSCs for Autoimmune Diseases
4.5.4 Clinical Trials Using MSCs for Diabetes
4.5.5 MSCs for Cardiovascular Repair
4.5.5.2 Application of MSCs in Joint Diseases
4.5.6 MSCs for Musculoskeletal Diseases
4.5.6.1 Studies Using MSCs for Musculoskeletal Indications by Leading Countries
4.5.7 MSCs in Neuron/Spinal Cord Diseases
4.5.8 MSC Infusion for GvHD
4.5.9 MSCs for Crohn’s Disease
5. A BRIEF OVERVIEW OF THE MARKET FOR STEM CELLS
5.1 Global Market for Stem Cells by Disease Indication
6. SELECTED COMPANY PROFILES
6.1 American Type Culture Collection Inc. (ATCC)
6.10 CellTherapies P/L
6.10.1 Services
6.10.2 Product
6.11 Cesca Therapeutics Inc.
6.11.1 Surgwerks
6.11.2 Cellwerks
6.11.3 AutoXress (AXP)
6.11.4 MarrowXpress (MXP)
6.11.5 Res-Q BMC
6.12 Cyagen Biosciences Inc.
6.12.1 Mesenchymal Stem Cells from Cyagen
6.12.10 General Cell Culture Supplements and Specialty Reagents from Cyagen
6.12.2 Adipose-Derived Mesenchymal Stem Cells from Cyagen
6.12.3 Mesenchymal Stem Cells with GFP from Cyagen
6.12.4 Adipose-Derived Mesenchymal Cells with GFP from Cyagen
6.12.5 Stem Cell Culture Media from Cyagen
6.12.6 Stem Cell Differentiation Media from Cynagen
6.12.7 Primary Cells from Cynagen
6.12.8 Cyagen’s Cryopreservation Media
6.12.9 Cyagen’s Primary Cell Culture Media
6.13 Cynata Therapeutics Ltd.
6.13.1 Cymerus Platform Technology
6.14 Cytori Therapeutics Inc.
6.14.1 Clinical Trial for Scleroderma
6.14.2 Clinical Trials for Osteoarthritis
6.15 Escape Therapeutics
6.16 Genlantis
6.17 Kite Pharma Inc.
6.17.1 Engineered Autologous Cell Therapy (eACT)
6.17.2 DC-Ad GM-CAIX
6.18 Life Technologies Corporation
6.19 Lonza Group Ltd.
6.19.1 Selected Products
6.2 Anterogen Co., Ltd.
6.2.1 Cupistem Injection
6.2.2 Queencell
6.20 Medipost Co. Ltd.
6.20.1 Cartistem
6.20.2 Neurostem
6.20.3 Pneumostem
6.21 Mesoblast Ltd.
6.21.1 Mesoblast’s Product Pipeline Overview
6.22 NuVasive Inc.
6.22.1 Osteocel
6.23 Octa Therapeutics Inc.
6.24 Organogenesis Inc.
6.24.1 Apligraf
6.24.2 Dermagraft
6.25 Orthofix International N.V.
6.25.1 Trinity Elite
6.25.2 Trinity Evolution
6.26 Osiris Therapeutics Inc.
6.26.1 Grafix
6.26.2 OvationOS
6.26.3 Cartiform
6.27 Pluristem Therapeutics Inc.
6.27.1 PLX Cells
6.28 PromoCell
6.29 Regeneus Ltd.
6.29.1 Products
6.3 Apceth GmbH & Co. KG
6.3.1 Apceth’s Research Areas
6.30 ScienCell Research Laboratories
6.31 Stemcell Technologies Inc.
6.32 Stemedica Cell Technologies Inc.
6.32.1 Stemedyne MSC
6.32.2 Stemedyne NSC
6.32.3 Stemedyne RPE
6.33 Stempeutics Research Pvt. Ltd.
6.33.1 Stempeucel
6.33.2 Stempeutron
6.33.3 Stempeucare
6.34 TiGenix N.V.
6.34.1 Cx601
6.34.2 Cx611
6.34.3 Cx621
6.35 Vericel Corporation
6.4 BioCardia Inc.
6.5 BioRestorative Therapies Inc.
6.5.1 brtxDISC
6.5.2 ThermoStem
6.6 Bone Therapeutics SA
6.6.1 PREOB
6.6.2 ALLOB
6.7 BrainStorm Cell Therapeutics Inc.
6.7.1 NurOwn
6.8 CellGenix Technologie Transfer GmbH
6.9 Celprogen Inc.

INDEX OF FIGURES

Figure 3.1: Number of Cell Therapy Clinical Trials, 2011-2014
Figure 3.2: Cell Therapy Clinical Trials (%) by Geography in 2014
Figure 3.3: Top Eight Countries in Cell Therapy Clinical Trials (%) in 2014
Figure 3.4: Major Cell Types in Cell Therapy Clinical Trials (Numbers) in 2014
Figure 3.5: Major Cell Therapy Clinical Trials (Numbers) by Indication in 2014
Figure 4.1: Schematic of Factors Impacting MSC Acquisition
Figure 4.2: Number of Clinical Trials Using MSCs, 2004-2014
Figure 4.3: Increasing Focus on the Immunological Properties of MSCs
Figure 4.4: Percentage of MSCs Clinical Trials by Different Phases
Figure 5.1: Global Market for Stem Cells, Stem Cell Services, Cord Blood Banking, Stem Cell Therapies and Bone Marrow Transplants, Through 2021
Figure 5.2: Global Market for Stem Cells by Disease Indication, Through 2021

INDEX OF TABLES

Table 2.10: Major Regulatory Milestones in RM Industry in 2014
Table 2.11: Major Data and Technology Events in RM Industry in 2014
Table 2.12: Major Pharma and Biotech Companies Active in Advanced Therapies in 2014
Table 2.13: Major Corporate Partnerships in RM Industry in 2014
Table 2.14: Anticipated Major RM Clinical Events in 2015
Table 2.15: NoTable Deals and Acquisitions in RM, Cell and Gene Therapy
Table 2.16: Big Pharma's Interest on Investing in RM by Sector
Table 2.17: Most Promising Areas in RM for Big Pharma
Table 2.1: Global Breakdown of Major RM Industries by Region

Table 2.2: Global Breakdown of RM Companies by Type, 2014
Table 2.3: Number of Therapeutic Companies, Approved Products and Clinical Trials, 2014
Table 2.4: Number of RM Clinical Trials by Phase in 2014
Table 2.5: Number of RM Companies by Disease Focus Area
Table:2.6: Major Financial Events in RM Industry in 2014
Table 2.7: Major Partnerships and Acquisitions in RM Industry in 2014
Table 2.8: Total Financings in RM Industry by Segment in 2014
Table 2.9: Type of Financing for RM Industry in 2013 and 2014
Table 3.10: Combination of Cell and Gene Therapy Products in Development
Table 3.11: Cancer Programs Utilizing the Combination of Cell and Immunotherapy
Table 3.12: Major Commercially Available Cell Therapy Products
Table 3.13: Cell Therapy Products Approved in South Korea
Table 3.14: A Sampling of Stem and Progenitor Cell-Based Trials with 2014 Readouts
Table 3.15: Major Cell Therapy Companies in the World
Table 3.16: Major Companies and Products in Development in Cell Therapy Sector
Table 3.1: Different Types of Stem Cells Used in Cell Therapy and their Characteristics
Table 3.2: Cell Therapy Product Candidates in Late-Stage Clinical Development
Table 3.3: Cell Therapy Product Candidates in Early-Stage Clinical Development
Table 3.4: Cell Therapy Products Being Developed for Cardiovascular Indication
Table 3.5: Cell Therapy Products Being Developed for Central Nervous System
Table 3.6: Cell Therapy Products Developed and Being Developed for Wound Care
Table 3.7: Cell Therapy Products for Spine and Orthopedics
Table 3.8: Cell Therapy Products Being Developed for Diabetes
Table 3.9: Cell Therapy Products Being Developed for Autoimmune Diseases
Table 4.10: Clinical and Experimental Therapies Using MSCs for Neural Diseases
Table 4.11: A Sample of Clinical Trials Using MSCs for Intestinal Diseases
Table 4.12: A Sample of Clinical Trials Using BMMSCs for Musculoskeletal Diseases
Table 4.13: ADSCs Transplantation in Clinical Trials by Region in Phase III, 2014
Table 4.14: Selected ADSC Secretomes and their Functions
Table 4.15: A Summary of Clinical Trials Using WJ-MSCs
Table 4.16: Clinical Trials Using UCBMSCs and Targeted Diseases
Table 4.17: Dominance of MSCs in 2014 Stem Cells Clinical Trials
Table 4.18: Clinical Trials Using MSCs by Disease Type, 2014
Table 4.19: A Sample of Clinical Trials Using MSCs for Liver Diseases
Table 4.1: Origin and Cell Typed Derived from MSCs
Table 4.20: A Sample of Clinical Trials Using MSCs for Neurodegenerative Diseases
Table 4.21: A Sample of Phase I and II Clinical Trials for Autoimmune Diseases
Table 4.22: A Sample of Clinical Trials Using MSCs for Diabetes
Table 4.23: A Sample of Clinical Trials Using MSCs for Cardiovascular Diseases
Table 4.24: Clinical Trials Involving MSCs for Bone and Cartilage Repair
Table 4.25: Studies Using MSCs for Musculoskeletal Indications by Countries in 2014
Table 4.26: A Sample of Current Clinical Trials Using MSCs for Osteoarthritis
Table 4.27: A Sample of Clinical Trials Involving MSCs for Bone and Cartilage Repair
Table 4.28: Clinical Trials Using MSCs for Neuron and Spinal Cord Diseases
Table 4.29: Clinical Experience of MSCs in GvHD Treatment
Table 4.2: Important Bioactive Molecules Secreted by MSCs and Their Functions
Table 4.30: A Sample of Clinical Trials Using MSCs for Crohn's Disease
Table 4.31: Clinical Studies Using MSCs for Wound Healing
Table 4.32: Selected MSCs Late-Stage Pipeline Therapies
Table 4.3: Immunomodulatory Effects of MSCs on Immune Cells
Table 4.4: Cell Surface Antigen Expressions of MSCs Isolaed from Different Sources
Table 4.5: Major Clinical Sources of MSCs
Table 4.6: A Sample of Clinical Trials Using BMMSCs for Kidney Diseases
Table 4.7: A Sample of Clinical Trials Using BMMSCs for Diabetes
Table 4.8: A Sample of Clinical Trials Using BMMSCs for Heart Diseases
Table 4.9: A Sample of Clinical Trials Using BMMSCs for Liver Diseases
Table 5.1: Global Market for Stem Cells, Through 2021
Table 5.2: Global Market for Stem Cells by Disease Indication, Through 2021
Table 6.10: Cyagen's Cryopreservation Media
Table 6.11: Cyagen's Primary Cell Culture Media
Table 6.12: General Cell Culture Supplements and Specialty Reagents from Cyagen
Table 6.13: Escape Therapeutics' Pipeline Products
Table 6.14: Kite Pharma's Pipeline and Clinical Trials
Table 6.15: Mesoblast's Product Pipeline Overview
Table 6.16: Octa's Pipeline of Therapeutic Programs
Table 6.17: Regeneus' Product Pipeline
Table 6.18: Stempeucel in Clinical Trials by Indication
Table 6.19: Vericel Corporation's Product Portfolio
Table 6.1: BioCardia's Product Pipeline Overview
Table 6.20: Summary Table for the Companies and Their Product Types
Table 6.2: Bone Therapeutics' Product Pipeline
Table 6.3: Cyagen's Mesenchymal Cells
Table 6.4: Cyagen's Adipose-Derived MSCs
Table 6.5: Cyagen's MSCs with GFP
Table 6.6: Cyagen's Adipose-Derived MSCs with GFP
Table 6.7: Cyagen's Stem Cell Culture Media
Table 6.8: Cyagen's Stem Cell Differentiation Media
Table 6.9: Primary Cells from Cyagen

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Anterogen Co., Ltd.
  • CellTherapies P/L
  • Cesca Therapeutics Inc.
  • Kite Pharma Inc.
  • Medipost Co. Ltd.
  • NuVasive Inc.
  • MORE

Mesenchymal stem cells (MSCs) are multipotent stem cells that can differentiate into a variety of cell types, including osteoblasts, chondrocytes, myocytes, adipocytes, beta-pancreatic islets cells, and potentially, neuronal cells. MSCs are of intense therapeutic interest because they represent a population of cells with the potential to treat a wide range of acute and degenerative diseases.
MSCs are advantageous over other stem cells types for a variety of reasons: they avoid the ethical issues that surround embryonic stem cell research, and repeated studies have found MSCs to be immuno-privileged, which make them an advantageous cell type for allogenic transplantation. MSCs reduce both the risks of rejection and complications of transplantation. Recently, there have been advances in the use of autologous mesenchymal stem cells to regenerate human tissues, including cartilage, meniscus, tendons, bone fractures, and more.

This global strategic report explores recent advances in MSC research applications, research priorities by market segment, and the competitive environment for MSC research products. It also identifies trend and growth patterns within the MSC industry. Because it is important for pharmaceutical companies interested to understand underlying forces affecting the MSC market, this report also presents a range of topics that apply to these companies, including how advances in MSC research can reveal potential new drug targets, improve methods of drug delivery, and provide personalized treatment strategies.

Literature and data concerning the biology and differentiation potential of mesenchymal stem cells (MSCs) has expanded rapidly over the past 10 years, with more than 13,000 publications now exploring aspects of MSC biology, behavior, and applications. In particular, MSCs appear to be an exceptionally promising tool for cell therapy because of their unusual characteristics, which partially mimic those of embryonic stem cells, while having advantages in terms of availability, expandability, ability to transplant and ethical implications.

Interest in therapeutic applications of human MSCs arises from their diverse ability to differentiate into a range of cell types, as well as from their ability to migrate to sites of tissue injury/inflammation or tumor growth. These localization properties present a promising strategy for targeted introduction of therapeutic agents through MSC gene therapy. In addition, MSCs possess strong immunosuppressive properties that medical researchers are exploiting for both autologous as well as heterologous therapies.
Clinical Progress with MSCs

As mentioned, mesenchymal stem cells (MSCs) have inspired a lot of activity over the past ten years as a novel therapeutic model for a wide range of diseases. Presently, MSCs-based clinical trials are being conducted for twelve types of disease conditions, with many completed trials showing their safety and efficacy.

The clinical utility of MSCs are mostly attributed to their four key biological properties, which are their potential to:
1. Migrate to sites of inflammation caused by tissue injury when injected intravenously
2. To get differentiated into different cell types
3. To release different bioactive molecules having the potential of stimulating recovery of injured cells and preventing inflammation
4. To accomplish immunomodulatory functions

Currently, there are 128 clinical trials involving MSCs are in progress in different parts of the world, including China, the European Union, the United States, the Middle East, and South Korea. Among these trials, 45 (35%) are exploiting MSCs for various disease indications. Currently, four major clinical trials using MSCs have reached Phase III. Stempeutics Research’s product candidate Stempeucel is being evaluated in two centers for treating critical leg ischemia. Prochymal is the product candidate from Osiris Therapeutics and it is being used for treating graft vs. host disease (GvHD). The company is also testing Prochymal for treating Crohn’s disease in another Phase III trial. The Australian company Mesoblast is testing an ‘off-the-shelf’ mesenchymal precursor product candidate for treating patients with hematological malignancies.
Since 1968, bone marrow transplantation (BMT) has been the gold standard treatment for blood cancer patients and others with genetic blood disorders. Each year more than 60,000 bone marrow transplantations are performed worldwide, and 58% of these procedures use autologous bone marrow and 42% of the cases use allogeneic bone marrow. Currently, the use of bone marrow is being replaced by the utilization of MSCs for some conditions.

The majority of cell therapy products currently being marketed are meant to address musculoskeletal conditions, and most of these products use MSCs as a component.

Note: Product cover images may vary from those shown

- Anterogen Co., Ltd.
- BioCardia Inc.
- BioRestorative Therapies Inc.
- BrainStorm Cell Therapeutics Inc.
- CellTherapies P/L
- Celprogen Inc.
- Cesca Therapeutics Inc.
- Cyagen Biosciences Inc.
- Kite Pharma Inc.
- Life Technologies Corporation
- Lonza Group Ltd.
- Medipost Co. Ltd.
- Mesoblast Ltd.
- NuVasive Inc.
- Orthofix International N.V.
- Osiris Therapeutics Inc.
- Pluristem Therapeutics Inc.
- Regeneus Ltd.
- ScienCell Research Laboratories
- Stemcell Technologies Inc.
- Stemedica Cell Technologies Inc.
- Vericel Corporation

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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