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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Currently there is no effective therapeutic approach to reverse the brain damage caused by stroke because adult brain cells have limited ability for self-repair and spontaneous axonal regeneration.

At the first glance, the repair of human brain after stroke appears unrealistic as there is a loss of countless number of neurons and glial cells. The functional improvement after stroke requires neuro-restorative process that includes neurogenesis, angiogenesis and synaptic plasticity, or ability of the connection between two neurons to change its strength. Stem cell therapy has the potential to induce all three neuro-restorative processes and to facilitate functional recovery offering a new approach to regenerate damaged brain tissue in stroke patients.

However, in comparison to stem cell-based therapy for other indications, such as cardiac diseases, peripheral arterial disease, diabetes and even spinal cord injury, the number of preclinical research or clinical studies in patients with stroke is very limited. This is the reason that there is still uncertainty in selection of the best type of stem cells for cellular grafts in stroke, or understanding of mechanisms involved in functional recovery and structural reorganization of damaged brain.

When considering stem cell therapy for the treatment of stroke, it is important to remember that brain is a very complex structure containing a maze of various cells, neuronal extensions, electrical signals and chemical transmissions, presenting extremely difficult task for its regeneration and functional recovery.

To be efficient, stem cell-based therapies for stroke are expected to fulfill two goals: they have to provide better circulation in brain through angiogenesis or neoangiogenesis, and to regenerate lost brain tissue.

Stem Cell Therapy for Stroke report shows pipeline that contains only eight R & D products undergoing development by 11 companies. Out of eight products only one product is in Phase III clinical trials and for one product the Investigational New Drug (IND) application is approved. Further analysis reveals that this R & D pipeline is the most conservative when compared to stem cell therapeutic R & D pipelines for the treatment of cardiac diseases, peripheral arterial disease, diabetes and spinal cord injury.

The majority (87%) of stem cells used for the treatment of spinal cord injury are mesenchymal stem cells and mesenchymal-like stem cells, which are undifferentiated in 88% of those products. Autologus stem cells, obtained from patient’s own tissues are used only in 37% of all products and embryonic-derived stem cells were not used in any of products undergoing development for the treatment of stroke

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Aarkstore Enterprise is a leading provider of business and financial information and solutions worldwide. We specialize in providing online market business information on market research reports, books, magazines, conference at competitive prices, and strive to provide excellent and innovative service to our customers. Our customers include more than 700 leading financial institutions, professional service firms, consulting, law and accounting firms and other corporations throughout the world.

Stem Cell Therapy for Spinal Cord Injury report presents 12 R & D stem cell-based product profiles, 10 company profiles and investors information. This report emphasizes advantages and disadvantages of particular cell therapies for spinal cord injury, characteristics and origin of used cells, mechanism of their action, efficacy and adverse effects, mode of delivery, design of clinical trials and result of completed clinical studies.

When considering stem cell therapy, as the new avenue for the treatment of spinal cord injury, it is important to remember that spinal cord is a very complex structure containing a maze of various cells, neuronal extensions, electrical signals and chemical transmissions, presenting extremely difficult task for its regeneration and functional recovery. In addition, injured spinal cord represents one of the most hostile tissue environments for survival and therapeutic effect of transplanted stem and progenitor cells.

Analysis reveals that in the last two years research related to stem cell therapies for the treatment of spinal cord injury had abruptly and significantly shifted from mesenchymal and mesenchymal-like stem cells towards neural stem cells. However, in the commercial R & D pipeline, undergoing development by various companies, the majority (75%) of stem cells used for the treatment of spinal cord injury are mesenchymal stem cells and mesenchymal-like stem cells, which are undifferentiated in 55% of those products. Autologus stem cells, obtained from patient’s own tissues are used in 66%, embryonic-derived stem cells in 17% and allogenic stem cells in 17% of all stem cell transplantations for the treatment of spinal cord injury. Half of products are in preclinical stage of development and only one is in Phase II clinical trials. Out of 10 companies involved in research and development of stem cell-based therapies for spinal cord injury eight are from the USA, one is from Asia and one is from Europe. None of the major pharmaceutical or biotechnology companies are involved in development of stem cell products for the treatment of spinal cord injury.

In conclusion, this pipeline needs update with introduction of more adult neural stem cells-derived and embryonic stem cells-derived products and more investment by large pharmaceutical companies.

Expects that in the future profiles of stem cells used for the treatment of spinal cord injury will change from mesenchymal and mesenchymal-like stem cells and their progenitor to neural stem/progenitor cells. In addition, biodegradable scaffolds will be preferred mode of delivery of stem cells into injured spinal cord and surrounding tissue.

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Aarkstore Enterprise is a leading provider of business and financial information and solutions worldwide. We specialize in providing online market business information on market research reports, books, magazines, conference at competitive prices, and strive to provide excellent and innovative service to our customers. Our customers include more than 700 leading financial institutions, professional service firms, consulting, law and accounting firms and other corporations throughout the world.





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