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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.

Advancements In Stem Cell Research And Multiple Sclerosis Treatments

Multiple sclerosis is a disease of the immune system that affects the central nervous system, or brain and spinal cord. A form of auto-immune disease, the disease damages the nerves and may affect separate or multiple parts of the body, causing pain and severe limitation to movement, ability, and quality of life.

The disease causes damage and destruction to the protective covering (myelin sheath) that surrounds nerve cells. Damage to the myelin sheath severely slows or interrupts nerve impulses, causing intense pain and inability to control movement. Individuals diagnosed with multiple sclerosis experience episodes of inflammation that cause the body’s immune cells to attack the nervous system.

Stem cell research and technology has searched for ways to minimize symptoms, flair-ups, and damage caused to the nerves by multiple sclerosis in countries around the world.

Stem Cell Technologies and Multiple Sclerosis
In recent months, treating a patient who has been diagnosed with multiple sclerosis with their own immune system stem cells has shown promise in some clinical trials where severe nerve cell damage has not yet occurred.

Clinical trials developed at the Northwestern University Feinberg School Of Medicine in Chicago removed patient’s stem cells in bone marrow, injected chemicals to destroy damaged immune cells and then re-injected the stem cells into the patient’s bodies. Three years later, none of the 23 individuals who engaged in the clinical trials experienced further deterioration, while 17 of them showed some improvement.

In further studies, adult stem cells that have been taken from a patient’s fatty tissues have shown promise in reducing clinical manifestation of the disease process. Clinical trials using mesenchymal stem cells showed improvement, according to the Journal Of Translational Medicine, describing studies performed at the University of California San Diego. Mesenchymal stem cells have been shown to reduce or stop immune activation of cells and target specific areas where tissue damage had occurred.

Use of stem cell technologies to treat multiple sclerosis is designed to literally “reset” immune system function and is focusing on reversing or slowing early diagnosis of multiple sclerosis. Recently, an international symposium (Stem Cell Transplantation in Multiple Sclerosis: Sharing The Experience) was conducted in Moscow, Russia to discuss perspectives in new methods of treating multiple sclerosis through autologous hematopoietic (bone marrow stem cells that may ‘morph’ or develop into a variety of stem cell types)stem cell transplantation combined with high dose immunosuppressive therapies.

The Future of Treatment
In recent months, Brainstorm Cell Therapeutics, Inc., has developed a therapeutic approach for potential treatment of multiple muscular conditions including Parkinson’s disease, ALS and multiple sclerosis. Multiple sclerosis treatments are currently being conducted on mouse models, with results published in the Journal Of Molecular Neuroscience.

Benefits of such treatment offer individuals diagnosed with multiple sclerosis, especially those diagnosed early, with renewed neural and muscular function, reduced symptoms and enhanced quality of life. News articles abound with stories of various stages of recovery of those who have undergone stem cell treatment for multiple sclerosis, some who have even recovered the ability to walk.

From Australia to Europe, individuals undergoing clinical trials of stem cell therapy have been showing a 60 to 80% chance of slowing the disease process, while some may enjoy the benefits of reversing the disease in its entirety. While there is no cure as yet for multiple sclerosis, stem cell treatments that focus on repair and regeneration of the central nervous system offer hope to individuals suffering from neural damage around the globe.

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Development In Stem Cell Research

Researchers at the Stanford University School of Medicine believe they have taken the first step forward in developing a new technique of creating nerve cells without having to collect stem cells, which may help reduce the amount of controversy involved in the field of stem cell research.

Scientists at the university were able to transform the skin cells of the mouse into functioning nerve cells, and exciting development in the study and research of regenerative medicine, especially in diagnosis of Alzheimer’s, Parkinson’s, and other neural degenerative disease processes.

Stem cell research continues to be a leading field in the 21st century for the treatment of chronic diseases like diabetes and heart disease, conditions caused by birth defects or spinal cord injuries caused by accidents.

Stem cell therapy, neural stem cell therapy, umbilical cord stem cell therapy and stem cell based therapy are leading the news these days, with new developments and discoveries keeping hope alive for those diagnosed with diabetes, heart or brain injuries and conditions. Stem cell therapy possibilities continue to be developed for potential for treatment in skin conditions and anti-aging skin treatment, orthopedic treatments, and cardiac care, treatment of multiple types of cancer like bladder cancer, bone cancer and lung cancer, and in plastic and reconstructive surgeries and procedures.

Facilities such as EmCell Clinic in Kiev, Ukraine and Integra Medical Center in Tamps, Mexico, offer individuals from around the globe alternative medical treatments and procedures for a wide variety of conditions and the best stem cell surgery abroad.

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Embryonic Stem Cell Research

Embryonic stem cells (ES cells) are stem cells derived from the inner cell mass of an early stage embryo known as a blastocyst. Human embryos reach the blastocyst stage 4-5 days post fertilization, at which time they consist of 50-150 cells. Embryonic Stem (ES) cells are pluripotent. This means they are able to differentiate into all derivatives of the three primary germ layers: ectoderm, endoderm, and mesoderm.

Simply defining, embryonic stem cells are stem cells derived from the inner cell mass of an early stage embryo known as a blastocyst. Human embryos reach the blastocyst stage 4-5 days post fertilization, at which time they consist of 50-150 cells. Embryonic stem cells are pluripotent, which means that they have the ability to differentiate into organized masses of tissues or organs.

The results of this experiment suggested an improvement in locomotor recovery in spinal cord-injured rats after a 7-day delayed transplantation of human ES cells that were pushed towards an oligodendrocytic lineage.

One of the greatest advantages of embryonic stem cell research is the possibilities associated to cloning. Embryonic stem cells are the ideal candidates for cloning. They contain information on every cell in the body and they can be manipulated in nearly any way imaginable. Scientists believe they can grow limbs and organs that could be transplanted into humans. These could be exact DNA matches which would make the transplant process more efficient and have a greater chance of succeeding.

Embryonic stem cells (ES cells) were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman and independently by Gail R. Martin. Gail R. Martin is credited with coining the term ‘Embryonic Stem Cell’. A breakthrough in human embryonic stem cell research came in November 1998 when a group led by James Thomson at the University of Wisconsin-Madison first developed a technique to isolate and grow the cells when derived from human blastocysts.

Embryonic stem cell research has been promoted because it has the ability to cure a number of deadly diseases.

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Stem Cell Therapy Perspectives In Treating Motor Neuron Diseases Als And SmaAarkstore Enterprise Market Research Aggregation

Summary

Motor neuron diseases (MNDs) are characterized by gradual and progressive degeneration and death of motor neurons. Normally, messages from nerve cells in the brain, or upper motor neurons, are transmitted to nerve cells in the brain stem and spinal cord, known as lower motor neurons, and from there to skeletal muscles. Upper motor neurons direct the lower motor neurons to produce movements such as walking or chewing. Lower motor neurons control movement in the arms, legs, chest, face, throat, and tongue. Currently, there is no
cure for MNDs.

Motor neuron diseases include: amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease), post-polio syndrome (PPS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), pseudobulbar palsy (spastic), progressive bulbar palsy (spastic and flaccid), and spinal muscular atrophy (SMA).

However, currently only amyotrophic lateral sclerosis (ALS, Lou Gehrigs disease) and spinal muscular atrophy (SMA Type I) attract attention of various companies as potential targets for stem cell therapy.

Stem Cell Therapy Perspectives in Treating Motor Neuron Diseases: ALS and SMA pipeline contains 7 R & D products undergoing development by 6 companies, all from the USA. Out of 7 products one product is in Phase I/II, three are in Phase I clinical trials, and three products are in preclinical stage of development. Six products are undergoing development for ALS, and one for ALS and SMA. The majority of adult stem cells used for the treatment of ALS and SMA are autologous, only one stem cells-based product is allotransplant. Patients own bone marrow was source of adult stem cells in four products, patients own skin in one product, fetal spinal cord tissue in one product, and embryonic stem cells in one product. Motor neurons were differentiated for use in two products. If there are no major setbacks, including alarming adverse effects, Expects that this pipeline will progress relatively efficiently. Possible positive therapeutic effects of motor neuron cell-based products for the treatment of both ALS and SMA may be expected. When evaluating results of products in this pipeline, it is important to remember that alternative for patients is death, and any positive result will have enormous significance.

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How Can Stem Cell Research Affect You

Stem cell research, though limited in the United States, is going ahead at a feverish pace in many other countries. Most European countries have government backed stem cell research programs. It is not the intention of this site or author to get into a political discussion on the ethics of stem cell therapy, only to show that it works and can be very useful in easing human suffering and returning some adults to a near normal level of functioning.

The most politically charged and ethic-bending form of stem cell research involves embryonic stem cells. The cells of an unborn fetus are used to test their ability to repair and re-grow adult tissue. Most people are unaware, or ignore, that the adult body naturally carries its own stem cells. These cells exist to repair tissue damage. Some of today’s cutting edge stem cell research is done with those cells that are taken directly from a patient’s body and used to re-grow tissue and re-implant it into the donor’s own body.

A case in point of this type of stem cell therapy would be Claudia Castillo, a young mother of two who had suffered from tuberculosis for several years. A severe bout left her with a badly damaged lung that doctors thought may have to be removed. Dr. Paolo Macchiarini thought that a windpipe transplant would do, instead. As with most transplants the biggest fear is that the new organ will be rejected, but if you use the patient’s own stem cells to line the new organ, the body is less likely to reject it. After a donor organ was found it was stripped of all cells, Ms Castillo’s stem cells were taken from bone marrow in her hip and used to line the new windpipe with her own cells. At this time she is living a near normal life without having to take immunosuppressant drugs. These drugs can cause high blood pressure and cancer.

I have simplified the process quite a bit, but the end results are well documented in the San Francisco newspapers and the American Society of Transplantation Journal. The ramifications of this type of stem cell research are enormous. Not only can it be applied to windpipe transplants for adults and children, but why not arthritis sufferers or people with chronic inflammatory bursitis. The worn out tissue can be replaced by cells that are currently in your body, thus minimizing rejection and nearly eliminating any ethical or religious arguments to the treatment.

There is currently research going on into the use of adult stem cells in cerebral palsy, spinal cord trauma, arthritis, and many auto-immune disorders. The debate still rages on about the use of embryonic stem cells, but where and what are the issues with an adult using their own cells to help heal themselves? There are products available that claim to be able to enhance adult stem cell production all naturally. I cannot tell you what to do, but I cannot see any reason that this type of research should not be used to ease the pain and stiffness of elderly patients so that they can have a better quality of life, later in life.

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Stem Cell Therapies AdvancedStage Clinical TrialsAarkstore Enterprise Market Research Aggregation

Presently, there are over 160 stem cell-based therapeutic products undergoing development for the treatment of various diseases, including cardiac, immune, neurodegenerative, ophthalmic and peripheral artery diseases, diabetes, spinal cord injury and stroke, as well as for some other indications.

Although majority of products in development are in preclinical stage, 27 products are in Phase II and III clinical stage.

Market research report Stem Cell Therapies: Advanced-Stage Clinical Trials features detailed profiles of all 27 products, including indications, state and stage of development, clinical trials details with primary and secondary outcome measures and time frames (start and estimated completion of clinical trials), product characteristics and mechanism of action, underlying technologies, results of clinical trials (if available), product origin, developing and co-developing companies and cooperation agreements.

Out of 27 analyzed products, the majority of products (59%) are in Phase II clinical trials, 7 products are in Phase III and 4 are in Phase II/III. For one product, after completed Phase III clinical trial, expanded access is available. Total of 11 clinical trials are expected to be completed in 2010. One company even expects that its R & D product may be approved by the end of 2010.

Autotransplants from patient’s own tissue are leading with 63% of all stem cell transplantations. Also, bone marrow, patient’s own or donor’s, was source of stem cells in 63 % of all products. Undifferentiated mesenchymal and mesenchymal-like stem cells are used in 11 (41%) of all products.

The majority (48%) of stem cell-based products in advanced stage of clinical trials are for the treatment of cardiovascular diseases, including cardiac diseases, stroke and peripheral arterial disease.

Total of 21 companies have stem cell-based R & D products in advanced stage of development, with 8 of them from the USA and 7 from Europe. This difference between the USA and European companies is very narrow and reflects highly progressive development of stem cell-based products in Europe, where Germany and Spain are the leading countries in this field.

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Stem Cell Researchthe New Avatar to Modern Day Medicine

Stem cells and their recognization in the treatment of various ailments begun with the unearthing of the concept by Ernest A. McCulloch and James E.Till in the 1960s. Stem cells are basic cells and are still in their undifferentiated state. They are the potential candidates which upon rapid mitotic divisions will give rise to specialized cells after undergoing a process called cell differentiation. A differentiated cell is a specialized cell and constitutes the structural and functional basis of a tissue-system in a multicellular organism. Stem cells are distinctive from any other adult cell of the body in that

They are capable of continuous mitotic divisions and self-renewal over long periods without undergoing the process of differentiation. This property is called cell proliferation.

Stem cells are unspecialized and undifferentiated. They are therefore capable of specialization along a specific cell line upon receiving certain signals. The signals are by way of internal gene commands. The microenvironment of the cell generated by specific chemicals secreted by adjoining cells upon physical contact and otherwise triggers the process of specialization referred to as differentiation. Presence of protein Oct-4 is a factor that assists in turning on or off the genes responsible for differentiation. It does so by controlling transcription in undifferentiated cells.Stem cells also referred to as progenitor cells or mother cells and are broadly sorted out as

Embryonic stem cells which are derived from the 32-64 cell stage of the blastocyst or early morula stage during development of the fertilized egg. During this time the fertilized egg now referred to as blastula is 5-6 day old. Its appearance is similar to the mulberry fruit. In normal course of development the outer most cells referred to as epiblast are capable of giving rise to all the derivatives of three primary germ layers namely ectoderm, mesoderm and endoderm. Each of these layers has its unique role in development of specific cell type contributing to the formation of a specific organ and organ system. Presence of cell surface proteins such as glycolipid SSEA3, SSEA4 and keratin sulfate antigens besides Fibroblast Growth Factor FGF-2 and genetic manipulation is instrumental in infusing differentiation.

Adult stem cells are found primarily in the bone marrow and in a few other adult tissues. Their multiplication helps to replenish the depleting specialized cells to a constant number.

Cord blood stem cells lie in the in the umbilical cord of the foetus.

Stem cells are totipotent. This means that they are capable of being transformed into any specialized cell. Stem cells that keep dividing without undergoing the process of differentiation are called pluripotent cells. Unipotent stem cells are capable of generating only one line of specialized cells.

Multipotent stem cells of the type found in bone marrow contain hematopoietic cells. These cells are capable of differentiating into multiple varieties as red blood cells, white blood cells and platelets. Stem cells offer permanent solution to treat deadly diseases and eliminates the role of modern medicine. It does so by way of utilizing reparative or regenerative cell based therapy. Diseases as cancer, heart ailments, osteoarthritis, spinal cord injury, Alzheimer and Parkinson’s disease will no longer be dreaded once this therapy is authenticated. They offer the possibility of renewable flow of fresh cells that replace defective cells. This is a life giving chance of rejuvination to the otherwise worn out and defective cells which were the underlying reasons for the manifestation of disease.

Cell based reparative therapy is successfully undertaken owing to the property called plasticity, inherent in stem cells. This means that undifferentiated cell from one tissue can be transformed into the specialized and differentiated cell capable of performing the function of yet another cell. Undifferentiated cells from neuron converted into blood cells or a heart muscle cell is an example of plasticity. Application of clonogenic assays of these undifferentiated stem cells in vitro culture can be used to beget specialized cell line.

Take the instance of a person suffering from osteoarthritis. Upon injection of proliferated differentiated stem cells into problem area, the existing diseased cells are soon replaced by fresh cells and are gradually incorporated into the existing tissue system. Once the integration is complete the functions of the recipient tissue carry on as on normal course. In this manner diseased cells are removed from the preview of the tissue system. However it needs to be ensured that newly differentiated cells included in the existing set up is not rejected by the recipient’s immune system.

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Stem Cell Research – Market Trends, Investment Trends and Pipeline Analysis

High Unmet Needs Associated with Chronic Diseases Boosts Stem Cell Research and Development
Stem cell therapies are expected to serve the unmet needs that are associated with treatment of certain chronic diseases. In spite of advancements in medical technology, there are very few treatment options available in the market to cure certain cardiovascular disorders, cancers, autoimmune and inflammatory disorders, spinal cord injury and others. Also, most of these therapies treat the symptoms without curing the disease. Stem cell therapies have the capacity to fill this gap of unmet need through its novel therapeutic approach that has the ability to cure the diseases. ( http://www.bharatbook.com/detail.asp?id=130308&rt=Stem-Cell-Research-Market-Trends-Investment-Trends-and-Pipeline-Analysis.html )

High Market Potential for Stem Cell Therapies has resulted in Establishing Strategic Partnerships between Large Pharmaceutical Companies and Stem Cell Research Based Companies
Strategic partnerships between Pharmaceutical companies and Stem cell research companies have given a boost to stem cell research and development. Almost 90% of the drugs in clinical trials fail due to factors such as lack of effectiveness and adverse side effects of the drug. Usually animal or tumor cells are being used and this leads to jury-rigged tests. Hence, all major pharmaceutical companies look forward to new technologies that would increase the possibility to launch new therapies in the market place. At present, there has been a spur in investments from pharmaceutical companies into stem cell research through strategic partnerships with stem cell research companies. Major pharmaceutical companies have planned and aligned their objectives to enter the stem cell market in the next five years. Pharmaceutical companies are also keen to explore various methods where stem cells could be utilized in the drug discovery process that would accelerate the discovery of novel drug molecules.

Promising Pipeline in Phase II and Phase III has Increased the Hopes of Commercialization of Stem Cell Therapies
The total number of stem cell clinical trials has increased tremendously over the last few years. The number of Phase II clinical trials has witnessed more than a 40% jump between 2005 and 2008. With more than five ongoing Phase III trials, the market is keenly awaiting the launch of these therapies within the next five years. The Preclinical research and Phase I trials have also increased at a phenomenal rate. This increase demonstrates the emerging interests in stem cell research across the globe.

Supportive Regulatory Environment Coupled with Increase in Investments have Bolstered the Growth of Stem Cell Research
In the United States, President Barack Obama has lifted the federal funding restrictions on embryonic stem cell research. With the removal of this barrier, the authority of the department of health and human services, including the National Institutes of Health (NIH) will encourage support for human embryonic stem cell research. This will enable new therapies and new discoveries and will potentially lead to dramatic advances in the understanding and treatment of conditions such as diabetes, heart diseases and Alzheimer’s. The federal funding and VC funding for stem cell research is also expected to increase with this amendment from the US government.

Key Geographies are Attracting Investments by Promoting Stem Cell Tourism
Countries that are advanced in providing stem cell therapies are taking advantage to attract investments from other countries by promoting stem cell tourism. The lack of stem cell therapy in a country forces the citizens suffering from debilitating conditions to travel to other countries where stem cell treatment is available. There has been an increase in the number of patients traveling from developed nations to countries like China, Thailand, Germany, Dominican Republic, Costa Rica, Israel and Argentina. Most of these countries promote stem cell tourism. This has the potential for excellent revenue generation for these countries.

The role of stem cell research as an integral part of therapeutics, as well as its commercial potential is now being recognized by most major countries of the world. Stem cell based therapies have immense market potential, driven by a strong pipeline that caters to high unmet needs. Stem cell research is now firmly on the path to being developed and commercialized fully. Currently, the technology is in its early stages of development, which implies that barriers to entry in this market are relatively low. Meeting the vast unmet need that stem cell research will eventually target, along with a strong pipeline of therapeutic candidates, suggests that it is a fast growing market that will offer attractive opportunities for investment in the near future.

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