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Strategic Development of Neural Stem and Progenitor Cell Products

Published By :

BioInformant

Published Date : Mar 2019

Category :

Stem Cell

No. of Pages : 211 Pages

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 undergoes 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 ageing 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.

Growth of stem cell research has exploded over the past decades, and the market to 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, outmanoeuvre your competition, and approach investors with specific and technical knowledge of the global market for neural stem cell and progenitor cell products.

About BioInformant

As is the first and only market research firm to specialize in the stem cell industry, BioInformant research is cited by the Wall Street Journal, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.

Table of Content

REPORT OVERVIEW
Statement of the Report
Executive Summary
INTRODUCTION
STEM CELLS: A BRIEF OVERVIEW
Embryonic Stem Cells
Induced Pluripotent Stem Cells
Types of Specialized Cells Derived from Stem Cells
Types of Stem Cells in the Human Body
Human Embryonic Stem Cells
Embryonic Germ Cells
Fetal Stem Cells
Umbilical Cord Stem Cells
Adult Stem Cells
Hematopoietic Stem Cells
Mesenchymal Stem Cells
Neural Stem Cells
Table NSCs, NPCs, and their Lineage-Specific Markers
Characteristics of Different Types of Stem Cells
Table Characteristics of Different Types of Stem Cells
NEURAL STEM CELLS: AN OVERVIEW
Sources of NSCs
Table Sources of NSCs and Advantages and Disadvantages in their Applications
Basal Properties of NSCs Obtained from Different Sources
Table Different Types of NSCs and their Basal Properties
BMSCs as a Sourse for NSC-Like Cells
UCBSCs: Express Pro-Neural Genes and Neural Markers
ESCs as a Source for NSCs
iPSCs as a Source of NSCs
Table Advantages and Disadvantages of iPSCs Utilization
Table Methods Used to Generate iPSCs
Table Chemicals Used for Neural Differentiation of iPSCs
Table Small-Molecule-Based Culture Protocols for Inducing hPSCs Differentiation
Table Compounds Used in Neural Stem Cell Research
Table Synthetic Compounds Used to Induce NSC Differentiation into Neurons
Table Natural Products that Are Known to Affect NSC Survival, Proliferation, and Differentiation
Fetal Stem Cell Transplantation for Neurodegenerative Diseases
Table Ongoing Clinical Trials of Fetal Stem Cell Transplantation for Neurological Diseases
Adult Human Neural Stem Therapeutics
Table The Various Methods of Isolation, Culture, and Expansion of aNSCs
Current Therapeutic Status of aNSCs
Table Preclinical Results (Rat) of aNSCs against Neurodegenerative Diseases
Table Trial ID and Title of Current Clinical Trials of aNSCs against Neurodegenerative Diseases
Table Trial ID, Cell Source, Location, and Phases of Current Clinical Trials of aNSCs
DEGENERATIVE DISEASES WITH POSSIBLE CURE USING NSCS
Conventional Treatments for Neurodegenerative Diseases
Table Conventional Treatments for Alzheimer's, Parkinson's, and Huntington's Diseases
NSC-Based and Traditional Approaches for Neurodegenerative Diseases
Table NSC-Based Approaches for Neurodegenerative Diseases
The Wide Gap Between Theory and Practice in NSC Applications
Types of NSCs Used for Cell Therapy Approaches
Fetal and Adult-Derived NSCs
NSCs from Pluripotent Stem Cells
Possible Therapeutic Actions of Grafted NSCs in Neurodegenerative Diseases
Most Recent Clinical Trials Using NSCs for Neurological Disorders
Table Some Recent Clinical Trials Using NSCs for Treating Neurological Diseases
Possible Outcome of Clinical Trials
Other Clinical Trials Using NSCs for Neurodegenerative Diseases
Table NCT Numbers and Titles of Clinical Trials Using NSCs for Neurodegenerative Diseases
Table Status of Different Clinical Trials Using NSCs for Neurodegenerative Diseases
Neurodevelopmental Disorders and Cell Therapy
Clinical Trials for Neurodevelopmental Disorders
Table NCT Number and Titles of Clinical Trials for Neurodevelopmental Disorders
Table Status of Clinical Trials Using NSCs for Neurodevelopmental Diseases
SPINAL CORD INJURY AND CELL THERAPY
Incidence of Spinal Cord Injury
Neurological Level and Extent of Lesion in Spinal Cord Injuries
Annual and Lifetime Cost of Treating SCI Patients in the US
Table Annual and Lifetime Cost of Treating SCI Patients in the US
Medications and Other Treatments for Spinal Cord Injury
Table Oral Medications and Other Treatment Options for SCI
CIRM Funding for Spinal Cord Injury
Table CIRM's Grants Targeting Spinal Cord Injury
Cell Therapy for Spinal Cord Injury
Table Genes Used for Engineering Cells
Studies in Animal Models of Cell Therapy for SCI
Table Preclinical SPI Trials Using iPSCs/ESCs for SCI
Table Preclinical Spinal Cord Injury Trials Using Mesenchymal Stromal Cells
Table Preclinical Spinal Cord Injury Trials Using NSCs/NPCs
Table Preclinical SCI Trials Using Olfactory Ensheathing Cells
Table Preclinical SCI Trials Using Schwann Cells
SCI Models and Effectiveness of Neuronal Regeneration
Table SCI Models and Effectiveness of Neuronal Regeneration
Clinical Trials Using Stem Cells for Spinal Cord Injury
Table Clinical Trials in Different Countries for SCI
ALZHEIMER'S DISEASE
Incidence of Alzheimer's Disease
Projected Number of People Aged 65 and Older with Alzheimer's Disease in the US
Cost of Care by Payment Source for US Alzheimer's Patients
Total Cost of Health Care, Long-Term Care, and Hospice for US AD Patients
Table Total Cost of Health Care, Long-Term Care, and Hospice for US Alzheimer's Patients
Currently Available Medications for Alzheimer's Disease
Table Currently Available Pharmacologic Therapies for Alzheimer's Disease
CIRM Funding for Alzheimer's Research
Table CIRM Funding for Alzheimer's Research
Transplantation of Stem Cells for AD
Table Stem Cell Therapy for AD in Mice Models
Gene Therapy for AD
Table Gene Therapy for AD
PARKINSON'S DISEASE
Incidence of Parkinson's Disease
CIRM Grants Targeting Parkinson's Disease
Table CIRM Grants Targeting Parkinson's Disease
Current Medications for PD
Table Medications for Motor Symptoms in PD
Potential for Cell Therapy in Parkinson's Disease
Table Advantages and Disadvantages of Stem Cell Types Used in PD
Gene Therapy for PD
Table Approaches Used in Current Gene Therapy Clinical Trials for PD
AMYOTROPHIC LATERAL SCLEROSIS
Incidence of ALS
Symptomatic Treatments in ALS Patients
Table Symptomatic Treatments in ALS Patients
CIRM Grants Targeting ALS
Table CIRM Grants Targeting ALS
Companies Focusing on Stem Cell Therapy for ALS
Table Companies Focusing on Various Strategies for ALS
Cell Therapy for ALS
Table Examples of Clinical Trials for Amyotrophic Lateral Sclerosis
MULTIPLE SCLEROSIS
Incidence of MS
Table Currently Available Medications for MS
Medications for MS
Neural Stem Cells' Application in Multiple Sclerosis
Table Available Studies Related to the Use of NSCs for Multiple Sclerosis
Stimulation of Endogenous NSCs with Growth Factors for MS Treatment
Table Growth Factors and Secreted Molecules Used for Stimulating Endogenous NSCs
CIRM Grants Targeting MS
Table CIRM Grants Targeting MS
STROKE
Incidence of Stroke
Currently Available Medication for Stroke
Stem Cell-Based Therapies for Stroke
Table An Overview of NSC Transplantation Experiments in Ischemic Stroke Models
Various Stem Cell Types Used in Stroke Experimental Studies
Table Representative Experimental Studies of Various Cell-Based Therapies for Stroke
Ongoing Clinical Trials for Stroke Using Stem Cells
Table Ongoing Clinical Trials of Cell-Based Therapies for Stroke
CIRM Grants Targeting Stroke
Table CIRM Grants Targeting Stroke
MARKET ANALYSIS
Current Stem Cell Landscape
Number of Stem Cell Product Candidates
Table Number of Therapies by Phase
Commercial Stem Cell Therapy Development by Geography
Commercially Attractive Therapeutic Areas
Table Stem Cell Product Candidates in Various Stages by Therapeutic Area
Major Companies Investing in Stem Cell Industry
Table Stem Cell Therapies in Phase III and Pre-Registration
Table Companies with Active Stem Cell Therapy Pipelines
Venturing of Big Pharma into Stem Cell Therapy Sector
Table Big Pharma's Involvement in Stem Cell Sector
Major Clinical Milestones in Cell Therapy Sector
TiGenics' Cx601
Mesoblast Ltd. and JCR Pharmaceuticals Co., Ltd.
Chiesi's Holocar
ReNeuron's Retinitis Pigmentosa Cell Therapy Candidate
Orphan Drug Designation to Pluristem's PLX-PAD Cells
Major Anticipated Cell Therapy Clinical Data Events
Table Major Cell Therapy Clinical Data Events
Global Market for Cell Therapy Products
Global Market for Neural Stem Cells
Table Global Market for Neural Stem Cells (NSCs), Through 2023
SELECTED COMPANY PROFILES
Asterias Biotherapeutics, Inc.
AST-OPC1
Atherdsys Inc.
MultiStem Programs
Ischemic Stroke
Clinical Programs (Stroke Phase II)
Ncardia (Formed by Axiogenesis AG / Pluriomics Merger)
Peri.4U - Human iPS Cell-Derived Peripheral Neurons
Dopa.4U - Human iPS Cell-Derived Dopaminergic Neurons
CNS.4U-Human iPS Cell-Derived Central Nervous System Cells (in
Astro.4U-Human iPS Cell-Derived Astrocytes (in development)
Axol Bioscience15
Cortical Neural Stem Cells
Cerebral Cortical Neurons
Sensory Neural Progenitors
Motor Neuron Progenitors
iPSC-derived Microglia
BrainStorm Cell Therapeutics
NurOwn in the Clinic
Cellular Dynamics International, Inc.
iCell Neurons
iCell Astrocytes
iCell DopaNeurons
Celther Polska
Cell Lines
Cellartis AB
hESC-Derived Mesenchymal Progenitor Cells
Human Neural Stem Cells
Culture System for iPSC
CellCure Neurosciences Ltd.
Technology
New Candidate Treatment for Retinal Diseases
Celvive, Inc.
Spinal Cord Injury
Research and Development
Merck Millipore
Human Neural Stem Lines
International Stem Cell Corporation
Neural Stem Cells
Kadimastem Ltd.
Drug Discovery for Neural Diseases
Human Oligodendrocyte Drug-Screening Assays
Living Cell Technologies Limited
NTCELL
MEDIPOST
NEUROSTEM
Neuralstem Inc.
Table Neuralstem Inc.' s Cell Therapy Products in Development
NSI-566 for ALS
NSI-566 for SCI
NSI-566 for Ischemic Stroke
NeuroGeneration Inc.
Drug Discovery
Biotherapeutics
Neurona Therapeutics Inc.
Technology
Ocata Therapeutics Inc. (Acquired by Astellas Pharma for $379M in November 2015)
Focus on Neuroscience
Opexa Therapeutics, Inc.
Tcelna
OPX-212
Abili-T Clinical Study
Table Opexa's Product Pipeline
ReNeuron Group PLC
Products and Technologies
Table ReNeuron's Pipeline Candidates
CTX Cells
Human Retinal Progenitor Cells
Exosome Platform
ReNcell Products
RhinoCyte, Inc.
Research
Roslin Cells Ltd.
Custom iPSC Generation
SanBio, Inc.
SB623
SB618
Table SanBio's Product Pipeline
Saneron CCEL Therapeutics Inc.
U-CORD-CELL Program
SERT-CELL Program
StemCells, Inc.
Clinical Programs
HuCNS-SC (human neural stem cells)
Proof of Concept
Proof of Safety and Initial Efficacy
Spinal Cord Injury
Age-Related Macular Degeneration
Pelizaeus-Merzbacher Disease
Neuronal Ceroid Lipofuscinosis
Stemedica Cell Technologies, Inc.
Technology
Products
STEMCELL Technologies, Inc.
Cell Culture Media for NSC and Progenitor Cells
Table STEMCELL Technologies' Cell Culture Media for NSCs
Talisman Therapeutics Ltd.
Xcelthera INC
Technology Platforms
PluriXcel-DCS Technology
PluriXcel-SMI Technology
PlunXcel-SMI Neuron Technology
PluriXcel-SMI Heart Technology
Products
Stem Cell and Cell Therapy Companies Worldwide

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