Strategic Development of Neural Stem and Progenitor Cell Products

  • ID: 4757329
  • Report
  • Region: Global
  • 211 Pages
  • BioInformant
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until Apr 30th 2019
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FEATURED COMPANIES

  • Athersys Inc
  • Celther Polska
  • Merck Millipore
  • NeuroGeneration Inc.
  • Ocata Therapeutics Inc.
  • RhinoCyte, Inc.
  • MORE

Neurogenesis is the process by which neurons are created. This process is most active during pre-natal development when neurogenesis is responsible for populating the growing brain. Neural stem cells (NSCs) are the self-renewing, multipotent cells that differentiate into the main phenotypes of the nervous system. These cell types include neurons, astrocytes, and oligodendrocytes. Neural progenitor cells (NPCs) are the progeny of stem cell division that normally undergo a limited number of replication cycles in vivo.

In 1992, Reynolds and Weiss were the first to isolate neural stem cells from the striatal tissue of adult mice brain tissue, including the subventricular zone, which is a neurogenic area. Since then, neural progenitor and stem cells have been isolated from various areas of the adult brain, including non-neurogenic areas like the spinal cord, and from other species, including humans. During the development of the nervous system, neural progenitor cells can either stay in the pool of proliferating undifferentiated cells or exit the cell cycle and differentiate. The past twenty years have seen great advances in neural stem cell research and applications.

NSCs can be regulated both in vitro and in vivo, which represent different commercial product opportunities. Neural stem cells have become of profound interest to the research community due to their potential to be used in drug discovery and delivery applications, as well as for tools of neural toxicology assessment. NSC transplantation also represents a ground-breaking approach for treating a range of chronic neurological diseases and acute CNS injuries, including Parkinson’s, Alzheimer’s and spinal cord injury, among other conditions.

Furthermore, neural stem and progenitor cells offer the potential to safely carry out pharmacology assessment for drugs designed to impact brain function or physiology. As tests on human cells become increasingly feasible, the potential grows for companies to develop disease-specific cell assays. As novel drug delivery agents, neural stem cells also show promise in killing gliomas and other cancers. To facilitate research resulting from these advances, a large and diverse market has emerged for neural stem cell products and services. One thriving component of the neural stem cell marketplace is the market for research reagents/supplies.

While the number of adult stem cell therapies entering clinical trials continues to expand, the development of neural stem cell therapies has been affected by barriers to entry that include patent restrictions, the complexity of neural stem cell applications, and burden of undertaking costly clinical trials. Despite these limitations, dozens of companies are now pursuing preclinical and clinical programs utilizing neural stem and progenitor cells as therapeutic products.

Pharmaceutical companies are demonstrating an interest in neural stem and progenitor cells. Because of their plasticity, ability to develop into the main phenotypes of the nervous system, and unlimited capacity for self-renewal, NSCs have been proposed for use in a variety of pharmaceutical applications, including:

  • Neurotoxicity testing
  • Cellular therapies to treat CNS conditions
  • Neural tissue engineering and repair
  • Drug target validation and testing
  • Personalized medicine

Utilization of neural stem cell products by the pharmaceutical sector represents a thriving segment of the overall NSC marketplace. Of interest to this community is the use of neural stem cells to heal tissues that have a naturally limited capacity for renewal, including the human brain and spinal cord.

Development of new drugs is extremely costly and the success rate of bringing new compounds to the market is unpredictable. Therefore, it is crucial that pharmaceutical companies minimize late-stage product failures, including unexpected neurotoxic effects, that can arise when candidate drugs enter the clinical testing stages. It is desirable to test candidate drugs using in vitro assays of high human relevance as early as possible. Because neural stem cells have the potential to differentiate into nearly all the main phenotypes of the nervous system, they represent an ideal cell type from which to design such neural screening assays.

The concept of stem cells as a potential cure for neurodegenerative diseases is not new. While neural stem cells (NSCs) have been explored for more than two decades for use in treating neurodegenerative and neurodevelopmental diseases, recent progress with developing NSCs from human-induced pluripotent cells has accelerated interest in developing cell-based therapeutics to target neurodegenerative diseases. As safety and efficacy results having been obtained from preclinical and clinical tests performed in animal models, companies have moved onto human clinical trials using NSCs derived from different sources. For the first time in history, there are companies developing technologies to support the autologous generation of neural stem cells by direct cell reprogramming.

Nearly one billion people in the aging population worldwide are affected by neurodegenerative diseases, there are no medications currently available to cure or stop the progression of these diseases. Available drugs can sometimes provide symptomatic relief, but they do not address the underlying disease, making alternative approaches badly needed. To date, researchers have successfully isolated, propagated, and characterized NSCs, and there are confirmed reports of neurogenesis of transplanted NSCs in the human brain. There has also been an upsurge in collaborative activities among pharmaceutical companies, research institutions, and start-up companies within the neurodegenerative market.

The growth of stem cell research has exploded over the past decades, and the market for neural stem cell and progenitor cell products is also expanding. Claim this 211-page global strategic report to reveal the current and future needs of the NSC marketplace, outmaneuver your competition, and approach investors with specific and technical knowledge of the global market for neural stem cell and progenitor cell products.

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

  • Athersys Inc
  • Celther Polska
  • Merck Millipore
  • NeuroGeneration Inc.
  • Ocata Therapeutics Inc.
  • RhinoCyte, Inc.
  • MORE

1. Report Overview
1.1 Statement of the Report
1.2 Executive Summary

2. Introduction

3. Stem Cells: A Brief Overview
3.1 Embryonic Stem Cells
3.2 Induced Pluripotent Stem Cells
3.3 Types of Specialized Cells Derived from Stem Cells
3.4 Types of Stem Cells in the Human Body
3.4.1 Human Embryonic Stem Cells
3.4.2 Embryonic Germ Cells
3.4.3 Fetal Stem Cells
3.4.4 Umbilical Cord Stem Cells
3.5 Adult Stem Cells
3.5.1 Hemotopoietic Stem Cells
3.5.2 Mesenchymal Stem Cells
3.5.3 Neural Stem Cells
3.6 Characteristics of Different Types of Stem Cells

4. Neural Stem Cells: An Overview
4.1 Sources of NSCs
4.2 Basal Properties of NSCs Obtained from Different Sources
4.2.1 BMSCs as a Source for NSC-Like Cells
4.2.2 UCBSCs: Express Pro-Neural Genes and Neural Markers
4.2.3 ESCs as a Source for NSCs
4.2.4 iPSCs as a Source of NSCs
4.2.4.1 Methods Used to Produce iPSCs
4.2.4.2 Chemicals Used for Neural Differentiation of iPSCs
4.2.4.3 Small-Molecule-Based Culture Protocols for Inducing hPSCs Differentiation
4.2.4.4 Compounds Used for NSC Proliferation
4.2.4.5 Sythetic Compounds Used to Induce NSC Differentiation into Neurons
4.2.4.6 Natural Products Affecting NSC Survival, Proliferation, and Differentiation
4.3 Fetal Stem Cell Transplantation for Neurodegenerative Diseases
4.4 Adult Human Neural Stem Therapeutics

5. Degenerative Diseases With Possible Cure Using NSCS
5.1 Conventional Treatments for Neurodegenerative Diseases
5.2 NSC-Based and Traditional Approaches for Neurodenerative Diseases
5.3 The Wide Gap Between Theory and Practice in NSC Applications
5.4 Types of NSCs Used for Cell Therapy Approaches
5.4.1 Fetal and Adult-Derived NSCs
5.4.2 NSCs from Pluripotent Stem Cells
5.5 Possible Therapeutic Actions of Grafted NSCs in Neurodegenerative Diseases
5.6 Most Recent Clinical Trials Using NSCs for Neurological Disorders
5.6.1 Possible Outcome of Clinical Trials
5.7 Other Clinical Trials Using NSCs for Neurodegenerative Diseases
5.8 Neurodevelopmental Disorders and Cell Therapy
5.8.1 Clinical Trials for Neurodevelopmental Disorders

6. Spinal Cord Injury And Cell Therapy
6.1 Incidence of Spinal Cord Injury
6.2 Neurological Level and Extent of Lesion in Spinal Cord Injuries
6.3 Annual and Lifetime Cost of Treating SCI Patients in the US
6.4 Medications and Other Treatments for Spinal Cord Injury
6.5 CIRM Funding for Spinal Cord Injury
6.6 Cell Therapy for Spinal Cord Injury
6.6.1 Studies in Animal Models of Cell Therapy for SCI
6.6.1.1 Preclinical Trials Using MSCs for SCI
6.6.1.2 Preclinical Trials Using NPCs for SCI
6.6.1.3 Preclinical Studies Using Olfactory Ensheathing Cells for SCI
6.6.1.4 Preclinical Studies Using SCs for SCI
6.7 SCI Models and Effectiveness of Neuronal Regeneration
6.8 Clinical Trials Using Stem Cells for Spinal Cord Injury

7. Alzheimer's Disease
7.1 Incidence of Alzheimer’s Disease
7.2 Projected Number of People Aged 65 and Older with Alzheimer’s Disease in the US
7.3 Cost of Care by Payment Source for US Alzheimer’s Patients
7.3.1 Total Cost of Health Care, Long-Term Care, and Hospice for US AD Patients
7.4 Currently Available Medications for Alzheimer’s Disease
7.5 CIRM Funding for Alzheimer’s Research
7.6 Transplantation of Stem Cells for AD
7.6.1 Gene Therapy for AD

8. Parkinson's Disease
8.1 Incidence of Parkinson’s Disease
8.2 CIRM Grants Targeting Parkinson’s Disease
8.3 Current Medications for PD
8.4 Potential for Cell Therapy in Parkinson’s Disease
8.5 Gene Therapy for PD

9. Amyotrophic Lateral Sclerosis
9.1 Incidence of ALS
9.2 Symptomatic Treatments in ALS Patients
9.3 CIRM Grants Targeting ALS
9.4 Companies Focusing on Stem Cell Therapy for ALS
9.5 Cell Therapy for ALS

10. Multiple Sclerosis
10.1 Incidence of MS
10.2 Medications for MS
10.3 Neural Stem Cells’ Application in Multiple Sclerosis
10.4 Stimulation of Endogenous NSCs with Growth Factors for MS Treatment
10.5 CIRM Grants Targeting MS

11. Stroke
11.1 Incidence of Stroke
11.2 Currently Available Medication for Stroke
11.3 Stem Cell-Based Therapies for Stroke
11.4 Various Stem Cell Types Used in Stroke Experimental Studies
11.5 Ongoing Clinical Trials for Stroke Using Stem Cells
11.6 CIRM Grants Targeting Stroke

12. Market Analysis
12.1 Current Stem Cell Landscape
12.1.1  Number of Stem Cell Product Candidates
12.1.2  Commercial Stem Cell Therapy Development by Geography
12.1.3  Commercially Attractive Therapeutic Areas
12.1.4  Major Companies Investing in Stem Cell Industry
12.1.5  Venturing of Big Pharma into Stem Cell Therapy Sector
12.2 Major Clinical Milestones in Cell Therapy Sector
12.2.1  TiGenics’ Cx601
12.2.2  Mesoblast Ltd. and JCR Pharmaceuticals Co., Ltd.
12.2.3  Chiesi’s Holocar
12.2.4  ReNeuron’s Retinitis Pigmentosa Cell Therapy Candidate
12.2.5  Orphan Drug Designation to Pluristem’s PLX-PAD Cells
12.3 Major Anticipated Cell Therapy Clinical Data Events
12.4 Global Market for Cell Therapy Products
12.4.1  Global Market for Neural Stem Cells

13.  Selected Company Profiles
13.1 Asterias Biotherapeutics, Inc.
13.1.1 AST-OPC1
13.2 Athersys Inc
13.2.1 MultiStem Programs
13.2.2 Ischemic Stroke
13.2.3 Clinical Programs (Stroke Phase II)
13.3 Ncardia (Formed by Merger of Axiogenesis AG / Pluriomics
13.3.1 Peri.4U – Human iPS Cell-Derived Peripheral Neurons
13.3.2 Dopa.4U – Human iPS Cell-Derived Dopaminergic Neurons
13.3.3 CNS.4U - Human iPS Cell-Derived Central Nervous System Cells
13.3.4 Astro.4U - Human iPS Cell-Derived Astrocytes
13.4 Axol Bioscience
13.4.1 Cortical Neural Stem Cells
13.4.2 Cerebral Cortical Neurons
13.4.3 Sensory Neural Progenitors
13.4.4 Motor Neuron Progenitors
13.4.5 iPSC-derived Microglia
13.5 BrainStorm Cell Therapeutics
13.5.1 NurOwn in the Clinic
13.6 Cellular Dynamics International, Inc.
13.6.1 iCell Neurons
13.6.2 iCell Astrocytes
13.6.3 iCell DopaNeurons
13.7 Celther Polska
13.7.1 Cell Lines
13.8 Cellartis AB
13.8.1 hESC-Derived Mesenchymal Progenitor Cells
13.8.2 Human Neural Stem Cells
13.8.3 Culture System for iPSC
13.9 CellCure Neurosciences Ltd.
13.9.1 Technology
13.9.2 New Candidate Treatment for Retinal Diseases
13.10 Celvive, Inc.
13.10.1 Spinal Cord Injury
13.10.2 Research and Development
13.11 Merck Millipore
13.11.1 Human Neural Stem Lines
13.12 International Stem Cell Corporation
13.12.1 Neural Stem Cells
13.13 Kadimastem Ltd.
13.13.1 Drug Discovery for Neural Diseases
13.13.2 Human Oligodendrocyte Drug-Screening Assays
13.14 Living Cell Technologies Limited
13.14.1 NTCELL
13.15 MEDIPOST
13.15.1 NEUROSTEM
13.16 Neuralstem Inc.
13.16.1 NSI-566 for ALS
13.16.2 NSI-566 for SCI
13.16.3 NSI-566 for Ischemic Stroke
13.17 NeuroGeneration Inc.
13.17.1 Drug Discovery
13.17.2 Biotherapeutics
13.18 Neurona Therapeutics Inc.
13.18.1 Technology
13.19 Ocata Therapeutics Inc. (Acquired by Astellas Pharma for $379M in Nov. 2015)
13.19.1 Focus on Neuroscience
13.20 Opexa Therapeutics, Inc
13.20.1 Tcelna
13.20.2 OPX-212
13.20.3 Abili-T Clinical Study
13.21 ReNeuron Group PLC
13.21.1 Products and Technologies
13.21.2 Human Retinal Progenitor Cells
13.21.3 Exosome Platform
13.21.4 ReNcell Products
13.22 RhinoCyte, Inc.
13.22.1 Research
13.23 Roslin Cells Ltd.
13.23.1 Custom iPSC Generation
13.24 SanBio, Inc.
13.24.1 SB623
13.24.2 SB618
13.25 Saneron CCEL Therapeutics Inc.
13.25.1 U-CORD-CELL Program
13.25.2 SERT-CELL Program
13.26 StemCells, Inc.
13.26.1 Clinical Programs
13.26.2 HuCNS-SC (human neural stem cells)
13.26.3 Proof of Concept
13.26.4 Proof of Safety and Initial Efficacy
13.26.5 Spinal Cord Injury
13.26.6 Age-Related Macular Degeneration
13.26.7 Pelizaeus-Merzbacher Disease
13.26.8 Neuronal Ceroid Lipofuscinosis
13.27 Stemedica Cell Technologies, Inc.
13.27.1 Technology
13.27.2 Products
13.27.2.1 Stemedyne-MSC
13.27.2.2 Stemedyne-NSC
13.27.2.3 Stemedyne-RPE
13.28 STEMCELL Technologies, Inc.
13.28.1 Cell Culture Media for NSC and Progenitor Cells
13.29 Talisman Therapeutics Ltd.
13.30 Xcelthera Inc
13.30.1 Technology Platforms
13.30.2 PluriXcel-DCS Technology
13.30.3 PluriXcel-SMI Technology
13.30.4 PlunXcel-SMI Neuron Technology
13.30.5 PluriXcel-SMI Heart Technology
13.30.6 Products
13.30.6.1 Xcel-hNuP
13.30.6.2 Xcel-hNu
13.30.6.3 Xcel-hCardP
13.30.6.4 Xcel-hcM

Appendix
Appendix 1: Globally Distributed Stem Cell and Cell Therapy Companies

List of Figures
Figure 3.4: Types of Specialized Cells Derived from Stem Cells
Figure 3.5: Major Three Neural Lineages from Neural Stem Cells
Figure 3.6: Structure of a Neuron
Figure 3.7: Structure of Astrocytes
Figure 3.8: Structure of Oligodendrocytes
Figure 5.1: Approaches for Neural Stem Replacement for Neurodevelopmental Disorders
Figure 6.1: Causes of Spinal Cord Injuries
Figure 6.2: Neurological Level and Extent of Lesion in Spinal Cord Injuries
Figure 6.3: Types and Share of Different Types of Stem Cells Used in SCI Clinical Trials
Figure 7.1: Ages of People with Alzheimer’s Disease in the US
Figure 7.2: Number of People Aged 65 and Older with Alzheimer’s Disease in the US, 2050
Figure 7.3: Cost of Care by Payment Source for US Alzheimer’s Patients
Figure 12.1: Stem Cell Therapy Development
Figure 12.2: Number of Therapies by Phase
Figure 12.3: Global Market for NSCs, Through 2023

List of Tables
Table 3.1: NSCs, NPCs, and their Lineage-Specific Markers
Table 3.2: Characteristics of Different Types of Stem Cells
Table 4.1: Sources of NSCs and Advantages and Disadvantages in their Applications
Table 4.2: Different Types of NSCs and their Basal Properties
Table 4.3: Advantages and Disadvantages of iPSCs Utilization
Table 4.4: Methods Used to Generate iPSCs
Table 4.5: Chemicals Used for Neural Differentiation of iPSCs
Table 4.6 Small-Molecule-Based Culture Protocols for Inducing hPSCs Differentiation
Table 4.7: Compounds Used in Neural Stem Cell Research
Table 4.8: Synthetic Compounds Used to Induce NSC Differentiation into Neurons
Table 4.9: Natural Products Known to Affect NSC Survival, Proliferation, and Differentiation
Table 4.10: Ongoing Clinical Trials of Fetal Stem Cell Transplantation for Neurological Diseases
Table 4.11: The Various Methods of Isolation, Culture, and Expansion of aNSCs
Table 4.12: Preclinical Results (Rat) of aNSCs against Neurodegenerative Diseases
Table 4.13: Trial ID & Title of Clinical Trials of aNSCs against Neurodegenerative Diseases
Table 4.14: Trial ID, Cell Source, Location, and Phases of Current Clinical Trials of aNSCs
Table 5.1: Conventional Treatments for Alzheimer’s, Parkinson’s, and Huntington’s Diseases
Table 5.2: NSC-Based Approaches for Neurodegenerative Diseases
Table 5.3: Some Recent Clinical Trials Using NSCs for Treating Neurological Diseases
Table 5.4: NCT Numbers & Titles of Clinical Trials Using NSCs for Neurodegenerative Diseases
Table 5.5: Status of Different Clinical Trials Using NSCs for Neurodegenerative Diseases
Table 5.6: NCT Number and Titles of Clinical Trials for Neurodevelopmental Disorders
Table 5.7: Status of Clinical Trials Using NSCs for Neurodevelopmental Diseases
Table 6.1: Annual and Lifetime Cost of Treating SCI Patients in the US
Table 6.2: Oral Medications and Other Treatment Options for SCI
Table 6.3: CIRM’s Grants Targeting Spinal Cord Injury
Table 6.4: Genes Used for Engineering Cells
Table 6.5: Preclinical SPI Trials Using iPSCs/ESCs for SCI
Table 6.6: Preclinical Spinal Cord Injury Trials Using Mesenchymal Stromal Cells
Table 6.7: Preclinical Spinal Cord Injury Trials Using NSCs/NPCs
Table 6.8: Preclinical SCI Trials Using Olfactory Ensheathing Cells
Table 6.9: Preclinical SCI Trials Using Schwann Cells
Table 6.10: SCI Models and Effectiveness of Neuronal Regeneration
Table 6.11: Clinical Trials in Different Countries for SCI
Table 7.1: Total Cost of Health Care, Long-Term Care, and Hospice for US Alzheimer’s Patients
Table 7.2: Currently Available Pharmacologic Therapies for Alzheimer’s Disease
Table 7.3: CIRM Funding for Alzheimer’s Research
Table 7.4: Stem Cell Therapy for AD in Mice Models
Table 7.5: Gene Therapy for AD
Table 8.1: CIRM Grants Targeting Parkinson’s Disease
Table 8.2: Medications for Motor Symptoms in PD
Table 8.3: Advantages and Disadvantages of Stem Cell Types Used in PD
Table 8.4: Approaches Used in Current Gene Therapy Clinical Trials for PD
Table 9.1: Symptomatic Treatments in ALS Patients
Table 9.2: CIRM Grants Targeting ALS
Table 9.4: Companies Focusing on Various Strategies for ALS
Table 9.6: Examples of Clinical Trials for Amyotrophic Lateral Sclerosis
Table 10.1: Currently Available Medications for MS
Table 10.2: Available Studies Related to the Use of NSCs for Multiple Sclerosis
Table 10.3: Growth Factors and Secreted Molecules Used for Stimulating Endogenous NSCs
Table 10.4: CIRM Grants Targeting MS
Table 11.1: An Overview of NSC Transplantation Experiments in Ischemic Stroke Models
Table 11.2: Representative Experimental Studies of Various Cell-Based Therapies for Stroke
Table 11.3: Ongoing Clinical Trials of Cell-Based Therapies for Stroke
Table 11.4: CIRM Grants Targeting Stroke
Table 12.1: Number of Therapies by Phase
Table 12.2: Stem Cell Product Candidates in Various Stages by Therapeutic Area
Table 12.3: Stem Cell Therapies in Phase III and Pre-Registration
Table 12.4: Companies with Active Stem Cell Therapy Pipelines
Table 12.5: Big Pharma’s Involvement in Stem Cell Sector
Table 12.6: Major Anticipated Cell Therapy Clinical Data Events
Table 12.7: Global Market for Neural Stem Cells (NSCs), Through 2023
Table 13.1: Neuralstem Inc.’s Cell Therapy Products in Development
Table 13.2: Opexa’s Product Pipeline
Table 13.3: ReNeuron’s Pipeline Candidates
Table 13.4: SanBio’s Product Pipeline
Table 13.5: STEMCELL Technologies’ Cell Culture Media for NSCs
Table App. 1.1: Stem Cell and Cell Therapy Companies

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  • Asterias Biotherapeutics, Inc.
  • Athersys Inc
  • Axol Bioscience
  • BrainStorm Cell Therapeutics
  • Cellartis AB
  • CellCure Neurosciences Ltd.
  • Cellular Dynamics International, Inc.
  • Celther Polska
  • Celvive, Inc.
  • International Stem Cell Corporation
  • Kadimastem Ltd.
  • Living Cell Technologies Limited
  • Merck Millipore
  • Ncardia
  • Neuralstem Inc.
  • NeuroGeneration Inc.
  • Neurona Therapeutics Inc.
  • NEUROSTEM
  • Ocata Therapeutics Inc.
  • Opexa Therapeutics, Inc
  • ReNeuron Group PLC
  • RhinoCyte, Inc.
  • Roslin Cells Ltd.
  • SanBio, Inc.
  • Saneron CCEL Therapeutics Inc.
  • STEMCELL Technologies, Inc.
  • StemCells, Inc.
  • Stemedica Cell Technologies, Inc.
  • Talisman Therapeutics Ltd.
  • Xcelthera Inc
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Note: Product cover images may vary from those shown
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