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Stem Cells The science the benefits the debate and the future

While President Obama recently lifted the ban on federal funding for embryonic stem cell research imposed by President Bush eight years ago, some people continue to oppose this move and call it unethical. So, while the scientific community is thrilled by the news and says the research will lead to medical breakthroughs, some communities consider the research as a “slippery slope”. But, what exactly are stem cells and why are they so important as to generate hot debates among all sorts of circles – political, social, religious, and what not? Here’s a look at some of those details.

The science behind stem cells
What sets stem cells apart from other cells is their ability to turn into any other type of tissue in the body. A stem cell from the bone marrow, for example, can be transformed into a neuron or nerve cell in the brain.

Types of stem cells: Embryonic stem cells versus Adult stem cells
Broadly, there are two types of stem cells in humans – embryonic stem cells and non-embryonic stem cells. Embryonic stem cells (ESC), as the name suggests, are isolated from the inner cell mass of an early stage embryo (4-5 days post fertilization, and consisting of 50-150 cells). On the other hand, non-embryonic stem cells which are also known as adult stem cells are found in adult tissues.
Embryonic stem cells are pluripotent as opposed to adult stem cells that are multipotent. What this means is that embryonic stem cells can differentiate into any of the more than 220 cell types in the adult body (to be able to give rise to any mature cell type) while adult stem cells can only form a limited number of cell types (closely related family of cells).

Utility of stem cells
The importance of stem cell lies in the fact that they can be converted into any type of other cells or tissues in the body – neurons, pancreatic tissue, heart muscle cells, etc.
So, for example, stem cells harvested from your bone marrow can possibly be used to repair the damage in your heart muscle caused during a heart attack, or to correct blood disorders such as sickle cell anemia (anaemia) through transfusions of stem cells.
Stem cell therapy is believed to have the potential to dramatically change the treatment of human disease. Embryonic stem (ES) cell therapies have been proposed for regenerative medicine and tissue replacement after injury or disease.
But, it should be noted at this point that embryonic stem cell therapies are not in use yet. They are still only in the stage where medical researchers are testing them on animals.
On the other hand, adult stem cells have been successfully used to treat leukemia (leukaemia) and related bone/blood cancers utilizing bone marrow transplants.

The controversy
The controversy behind stem cell research pertains only to human embryonic stem cell research and not all stem cell research. What is controversial is the fact that the source of the research material, human embryos, is destroyed in the process of harvesting the stem cells. Pro-life activists oppose the research arguing that a human embryo is a human life that is entitled to protection.
Another area of controversy is that embryonic stem cell technologies are a slippery slope that may lead to reproductive cloning which may devalue human life.
The production of adult stem cells, on the other hand, does not require the destruction of an embryo and therefore, adult stem cell research and therapy are not as controversial. Though, adult stem cell treatment does carry a risk of rejection by the body’s immune system.

The present state of stem cell research
There are some countries that offer treatments using stem cells (read about medical tourism) but in such therapies only adult stem cells derived from the patient’s body are used (autograft). When possible, autografts are preferred as they remove the risk of rejection by the recipient’s body.
There is promising research ongoing in the field of stem cells to derive treatments for a wider variety of diseases including cancer, Parkinson’s disease, spinal cord injuries, diabetes, heart disease, Alzheimer’s disease, Amyotrophic lateral sclerosis or ALS (Lou Gehrig’s disease), multiple sclerosis, lung disease, arthritis, organ failure, and muscle damage, amongst a number of other impairments and conditions.

The future
The ultimate question on the minds of many is – “Why can’t we simply use adult stem cells instead of harvesting embryonic stem cells?”
Theoretically, embryonic stem cells are considered better because they work as a biological blank slate and are the most versatile of all stem cells whereas adult stem cells are sort of semi-specialized cells and are not as versatile as ESCs.
Though the field of adult stem cells is not marred by controversies, the problem with adult stem cells is also that they are often present only in minute quantities, are difficult to isolate and purify, and their numbers may decrease with age, according to a primer by the National Institutes of Health (NIH).
At this juncture, much remains unknown about the potential of embryonic stem cells. But, going by the success in the field of animal testing it may very well turn out that embryonic stem cells could provide solutions to many diseases in humans.
The answer to the potential benefits of ESC lies in research. To understand the benefits of embryonic stem cells or any type of stem cells for that matter, and to discover possible treatments in humans, various lines of research need to be pursued simultaneously.
Only research can prove if adult stem cells are better over embryonic stems cells for curing human diseases or vice versa. It may also emerge that adult stem cells offer good treatments for certain ailments, while embryonic stem cells are better for curing others.

About the author:
The author works for Healthbase (www.healthbase.com), a medical tourism facilitator that connects patients to high quality healthcare in USA and abroad for a fraction of the typical cost of care in US, Canada and UK.

Advances In The Stem Cell Industry The Future Impact Of Innovation And An Evaluation Of The Commercial LandscapeAarkstore Enterprise

This report takes the implications of IPS cells and other developments into account. Some essential technologies are already in place and stem-cell based therapies have already begun to appear in the marketplace. This has enabled the author to build market estimates based on emerging commercial realities. The stem cell market is already divided into three segments—cell-based treatments, umbilical cord blood banking, and the use of stem cells to evaluate the efficacy and safety of new drugs developed by other methods. Global sales reached $410 million in 2008, and will grow to $2.68 billion by 2012. This growth will reach a projected $5.1 billion in 2014, providing a realistic, and even cautious forecast of the commercial potential these segments.

The report also describes the potential for stem cell science as applied to drug discovery and toxicity testing To give a full industry perspective, the report offers profiles of a large number (approximately 50) of companies operating in this field, including all sizes and types of organisation from small start-ups based on a single technology to large concerns with established product portfolios. This report also describes the background of stem cell science and the current status of knowledge in this sphere. The approach does not shirk essential technical detail but it is written in an easily readable style and the depth of information provided is carefully assessed.

Key features of this report

Provides current status of the stem cell market, essential in a fast-moving field where up-to-date knowledge is paramount.
Another key quality for a report such as this is that it should be realistic. Whether one describes the glass as half-full or half-empty matters less than describing it as a half glassful. Market forecasts are refined to indicate the potential offered by this exciting new area of technology without ignoring the practical difficulties.
The scope for medical applications of stem cell science is broad and the report attempts to give as full a picture as possible, including applications that are as yet in development as well as those which are more advanced.
The report also describes the potential for stem cell science as applied to drug discovery and toxicity testing
To give a full industry perspective, the report offers profiles of a large number (approximately 50) of companies operating in this field, including all sizes and types of organisation from small start-ups based on a single technology to large concerns with established product portfolios.
The report describes the background of stem cell science and the current status of knowledge in this sphere. The approach does not shirk essential technical detail but it is written in an easily readable style and the depth of information provided is carefully assessed.

Key findings from this report

The main focus of applied stem cell research has been to explore the possibilities of using SCs in regenerative medicine, to replace normal cells and tissues destroyed by disease or trauma.
Primary therapeutic targets are nervous system disorders such as Parkinson’s disease and amyotrophic lateral sclerosis; cardiovascular disease including heart failure, myocardial infarction and severe peripheral arterial disease..
Stem cell science also offers the prospect of contributing to new drug discovery, for example by providing in vitro targets that can identify promising new candidates before any in vivo work has been undertaken.
Cell-based therapies may be divided into those using autologous cells and those using allogeneic cells. Each market has its own characteristics.
The world market for cell-based therapies is now estimated at $600 million, but there is great growth potential, given the high prevalence of eligible patients, once appropriate products reach the marketplace.
The US accounts for about 90% of the world market but other national markets will make inroads over the coming years, and grow faster than the US market.
Attrition among companies and products in the regenerative medicine market indicate that this is a demanding market environment requiring care in the choice of appropriate marketing model.

Key questions answered by this report

What are the main hitherto untreatable conditions for which stem cell therapy may provide new hope of cure?
Are embryo or adult stem cells the best prospect for future commercialization?
What is the present size of the global stem cell market, and how is it expected to grow?
Which are the leading national markets for stem cell products?
What is the nature of the ethical objection to stem cell manipulation?
What important factors need to be taken into account when formulating a business plan for stem cell commercialization.
Names the leading companies with stem cell products in advanced development.
Apart from the treatment of disease, what other roles are envisaged for stem cell products?
What are induced pluripotent stem cells, and why are they important?

Brainstorm
Genzyme
International Stem Cell Corporation
MedCell
MediStem
NuVasive
Opexa
Osiris
Plureon

Table of Contents :

Advances in the Stem Cell Industry
Executive summary 10
Background 10
Stem cell research and development: scope and status 10
Commercial landscape 11
Industry landscape 12
Chapter 1 Background 16
Summary 16
Introduction 17
The building blocks of life 17
About stem cells 18
Potency 20
Stem cell division 21
Stem cell research 21
Human ESCs 23
Current status of knowledge 24
Embryonic stem cells 24
Growth and identification of ESCs 25
Stimulating ESCs to differentiate 26
Adult stem cells 26
Cord blood stem cells 29
Induced pluripotent stem cells 30
Nuclear reprogramming 31
Ethical and regulatory issues 33
Situation in the US 33
European regulations 34
Chapter 2 Stem cell research and development: scope and status 38
Summary 38
Introduction 39
Practical applications of stem cells 39
Disease treatment 40
Amyotrophic lateral sclerosis 40
Parkinson’s disease 43
Spinal cord injury 44
Alzheimer’s disease 46
Cancer 48
Heart disease 49
Peripheral arterial disease 52
Type 1 diabetes 55
Liver failure 59
Graft-versus-host disease 60
Stem cell models: applications in drug discovery 61
Screening studies 61
Toxicity studies 63
Practical benefits 64
Some skepticism remains 65
Chapter 3 Commercial landscape 68
Summary 68
Resisting the hyperbole 69
Market realities 70
Cell-based therapy market 70
Autologous SC therapy 71
Allogeneic SC therapy 71
Cord blood banks 71
Market drivers 72
Market 73
Global market estimates and forecasts 74
Global market by use 75
Global market by country share 76
Embryo vs. adult stem cells 77
Investment opportunities 78
Choosing a viable business model 79
Matching the model to the circumstance 80
Autologous therapy models 80
Allogeneic therapy models 83
Chapter 4 Industry landscape 86
Summary 86
Introduction 87
Company profiles 89
Aastrom Biosciences, Inc. 89
Overview 89
Pipeline 90
Advanced Cell Technology, Inc. 90
Overview 91
Pipeline 91
Collaboration 92
Aldagen 92
Overview 92
Pipeline 92
Collaboration 93
Angioblast Systems, Inc. 93
Overview 93
Pipeline 94
Athersys, Inc. 95
Overview 95
Pipeline 95
Collaboration 96
Financials 96
Bioheart, Inc. 97
Overview 97
Pipeline 97
Bionet 98
Overview 99
Collaboration 99
Brainstorm Cell Therapeutics 99
Overview 100
Capricor, Inc. 101
Overview 101
Pipeline 101
Collaboration 102
Cardio3 BioSciences SA 102
Overview 102
Cellcyte Genetics 103
Overview 103
Pipeline 103
Collaboration 104
Cellerix SA 104
Overview 104
Pipeline 105
CellGenix Technologie Transfer 105
Overview 106
Cytori Therapeutics, Inc. 107
Overview 107
Entest BioMedical, Inc. 107
Overview 108
ES Cell International 108
Overview 109
EvoStem Finland Oy 109
Overview 110
Fate Therapeutics, Inc. 110
Overview 110
Genzyme 112
Collaboration 113
Financials 113
Geron 113
Overview 113
Pipeline 114
Healtheuniverse, Inc. 114
Overview 115
Innovacell Biotechnologie AG 115
Overview 116
International Stem Cell Corporation (ISCO) 116
Overview 116
Financing 118
iPierian, Inc. 118
Overview 118
Ixion Biotechnology, Inc. 119
Overview 119
Karocell Tissue Engineering AB 120
Overview 120
MedCell Bioscience Ltd 121
Overview 121
MediStem, Inc. 122
Overview 122
Pipeline 123
Mesoblast Limited 124
Overview 125
Nephrogenix 126
Overview 126
Neuralstem, Inc. 127
Overview 127
Pipeline 128
Collaboration 128
OncoStem Pharma 128
Overview 128
Novocell, Inc. 129
Overview 129
NuVasive, Inc. 130
Overview 130
Osiris Therapeutics, Inc. 131
Overview 131
Pipeline 131
Collaboration 132
Financials 133
Pharmicell Europe GmbH 133
Overview 133
PrimeGen Biotech 134
Overview 135
Opexa Therapeutics 136
Overview 136
Financing 136
Financials 137
Plureon 137
Overview 137
Pipeline 138
Collaboration 138
Proteonomix, Inc. 139
Overview 139
Regenerative Sciences, Inc. 140
Overview 140
ReNeuron 140
Overview 141
Pipeline 141
Shenzhen Beike 143
Overview 143
Stematix, Inc. 143
Overview 144
StemCells, Inc. 145
Overview 145
Stem Cell Therapeutics 146
Overview 147
Stem Cell Therapy International 147
Overview 147
Stemedica Cell Technologies, Inc. 148
Overview 148
Stempeutics Research Pvt. Ltd. 149
Overview 150
t2cure GmbH 150
Overview 151
TICEBA GmbH 152
Overview 152
Tristem 153
Overview 153
Chapter 5 Appendix 154
Methodology 154
Glossary 155
Index 162
List of Figures
Figure 1.1: Early embryonic development and later differentiation 19
Figure 1.2: Stem cell division 21
Figure 1.3: Induced pluripotent stem cells 31
Figure 2.4: Stem cell opportunities in disease treatment and R&D 40
Figure 3.5: Forces affecting the stem cell market 73
Figure 3.6: Key challenges faced when developing autologous therapy 83
Figure 4.7: Type and number of regenerative medicine organizations 87
List of Tables
Table 3.1: Global stem cell market ($m), 2008-14 74
Table 3.2: Potential US patient populations for cell-based therapies 75
Table 3.3: Stem cell market by main uses ($m), 2008-14 76
Table 3.4: Country breakdown of stem cell market ($m), 2008-14 77
Table 3.5: Leading cell-based regenerative medicine products 79

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Stem Cell Treatments Offer Hope For The Future

Continued efforts to research and develop embryonic stem cell treatments and procedures doesn’t merely mean cloning human beings or involve moral and ethical controversies or issues surrounding such research. Embryonic stem cells provide the basic building blocks and structure of the development of various cellular and tissue structure in the human body, and stem cell research irrefutably offers potential treatments that may eventually cure many disease processes, enable people with spinal cord injuries to walk again, and guide researchers to develop medications that will end to cognitive impairment diseases such as Alzheimer’s and Parkinson’s Disease.

Millions of cells found in the human body can and are being developed for future medical treatments. Stem cells contain specific instructions on how cellular structures replicate and function. Each cell is also programmed with how long it will live, it’s specific functions and tasks.

Stem cells come from different sources. The most commonly studied, and used, stem cell therapies involve:

* Embryonic stem cell therapy
* Adult stem cell therapy and research
* Umbilical cord stem cell therapy

EmCell Therapy
Professor Alexander Smikodub, M.D., PhD, is the founder of the Cell Therapy Clinic of the National Medical University and EmCell Clinic, as well as the inventor of treatment methods using embryonic stem cells in . The EmCell therapy clinic has been offering embryonic stem cell treatments in vivo to improve physical health for nearly two decades and has helped thousands of people suffering from disease processes like Parkinson’s, multiple sclerosis, diabetes, various types of muscular dystrophy, blood diseases and cancers.

Dr. Smikodub has performed thousands of embryonic stem cell transplants to international patients who arrived every month from foreign destinations such as China, Germany, and the United States (where stem cell therapy treatments have not been approved) to receive treatments that improve quality of life.

International Clinical Experience
The EmCell Therapy Clinic is one of the world’s largest fetal or embryonic stem cell transplantation centers that addresses various conditions and disease processes. Embryonic stem cell research and development continues to offer curative effects, which is one of the most promising aspects of cell research and therapies. The am so clinic focuses their attention on embryonic stem cell transplantation related transplantation of the basic building blocks of all tissues and organs, not the tissues or organs themselves, that are responsible for various functions in the body and provide the basic structures for musculature, blood, immune system, nervous and other body systems.

Stem cell therapies, and most potentially the potential of utilizing embryonic stem cells offer a multitude of benefits including but not limited to enabling cells to migrate directly to the site of injury or damage for repair or replication, establishing intercellular linkage and differentiation (developing into specific cellular structures such as muscle tissue, heart tissue, or neural tissues), In addition, benefits include enhancing immune responses and reducing and avoiding tissue and organ rejection.

EmCell, based in Kiev, Ukraine, was founded in 1994, a private clinic that has gained international recognition and reputation in the field of embryonic stem cell research and clinical applications. Focusing on effective prevention and antiaging programs, and devising and developing treatments and follow-up for complex clinical cases, the EmCell clinic focuses on indications as well as contraindications for severe acquired and genetic disease processes that are caused by decreased cell counts.

Embryonic stem cell research and development continues to be the most effective stem cell therapy yet developed by researchers and scientists. Embryonic stem cells are commonly cultivated from discarded fetuses or embryos resulting from abortions, and can be utilized to provide life-saving treatments for dozens of disease processes and health conditions.

Medical Stem Cell Tourism
The United States does not currently approve of stem cells therapy options, but Americans and other international travelers seek international destinations for promising treatments. Today, thousands of medical tourists venture to locations throughout the world, including China, Thailand, Japan, Europe, and India for treatments that offer beneficial and promising results.

The cost of therapies is determined according to geographic location of treatment facilities as well as the injury, illness or disease being treated. The U.S. is currently funding Phase I clinical trials of some types of stem cell therapies that may provide productive and beneficial use in the near future. In the meantime, individuals can reap the benefits of stem cell research and therapies offered around the world, such as the facilities found at EmCell Therapy in Kiev, Ukraine.

Stem Cells The science the benefits the debate and the future

Advances In The Stem Cell Industry The Future Impact Of Innovation And An Evaluation Of The Commercial LandscapeAarkstore Enterprise

Stem Cell Treatments Offer Hope For The Future

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