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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