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Marrow Isolated Adult Lineage Inducible (MIAMI) Cells

Organization:WVHTC Foundation (Non-profit contractor for the US Dept of Veterans Affairs), WV, US
I.P. Brief:A novel population of marrow-derived, adult pluripotent stem cells and methods of isolation, propagation and tissue-commitment is under development at the U.S. Department of Veterans Affairs. These cells can be utilized in autologous cellular therapies and tissue-engineering to repopulate or repair damaged, aged or diseased organs and tissues
Summary of I.P.:The available therapies for indications such as skeletal degeneration, neurodegenerative diseases, spinal cord injury, and vascular and endocrine disorders are limited in number and efficacy. Moreover, these therapies which typically involve pharmaceuticals tend to only treat the symptoms, and require frequent and repeated administration. In contrast, stem cells offer a viable alternative for the aforementioned indications and offer “single-dose” curative potential. Marrow-Isolated Adult Multilineage Inducible (MIAMI) cells are pluripotent, capable of differentiating into cells from all three germ layers (ectoderm, endoderm and mesoderm), and express markers typically only associated with embryonic stem cells. MIAMI cells display a unique molecular profile, distinguishing them from all other adult stem cell populations described to date. Specific culture conditions have been defined to maintain maximum cell viability and pluripotency, as well as to promote transdifferentiation into various cell progenitors useful for cell-based therapies and regenerative medicine, particularly for the treatment of bone, cartilage and neurological indications. MIAMI cells have shown early therapeutic efficacy for accelerating the healing of fractures and the treatment of Parkinson’s disease and spinal cord injuries. Importantly, MIAMI cells offer all the benefits of embryonic stem cells without any ethical stigma, feeder layer requirement or teratoma risk.
Patent:U.S. Provisional Patent Application 60/443,572. International Patent Application (PCT/US04/02580) was published under WO 2004/069172 A2.
Keywords:Adult stem cells, marrow-derived, pluripotent, transdifferentiation, regenerative medicine
Primary Industry:Pharma & Biotech
Specific Market:Tissue Engineering, Stem Cell-Based Therapy, Orthopedic and Neurological markets.
Market Size:The U.S. tissue engineering market is forecasted to reach $1.3 billion by 2007. The stem cell-based therapeutic market could grow to $25-30 billion by 2010. The total orthopedic market (bone and cartilage repair) may attain $27 billion by 2006.
State of the Art:Surgery, implants and orthobiologics are used to accelerate fracture repair. Pharmaceuticals (anti-resorptives and parathyroid hormone) are treatments for osteoporosis. For neurodegenerative disease such as Parkinson’s, dopamine and its derivatives are employed. Management of the pain associated with spinal cord injury usually involves OTC analgesics and prescription pain medicine.
Competition:Globally, more than 200 companies are involved in the research and development of cell therapy technologies. Over 150 companies are engaged in the development of therapeutic technologies for tissue engineering and transplantation.
Figures of Merit:By 2010, osteoporosis may afflict 52 million Americans. Annually, six million people experience major fracture and 2 million bone grafts are performed. Yearly, 15,000 people suffer spinal cord injury. Parkinson’s currently affects 1.5 million Americans. MIAMI cells hold curative potential for such bone, cartilage and neurological indications.
Tech.  Obstacles:Extensive in vivo studies are required to more accurately assess therapeutic application and potential and to address issues regarding optimal route of administration. Testing in humans to validate safety and therapeutic efficacy will also be needed.
Market Obstacles:1.Identification of protocols to store and expand MIAMI cells for human application. 2.Successful completion of clinical trials 3.Gaining acceptance from both the heath care and insurance provider communities. It should be noted that now Medicare provides coverage for therapies exceeding $5100.
Patent Landscape: Numerous patents exist for both adult and embryonic stem cells, including their isolation, propagation and transdifferentiation. MIAMI cells have a unique molecular profile that distinguishes them from all other stem cell populations characterized to date. Moreover, defined sets of culture conditions have been established for the propagation and tissue commitment of MIAMI cells.
Publications:D’Ippolito G, Diabira S, Howard GA, Menei P, Roos BA and Schiller PC. 2004. Marrow-isolated adult multilineage inducible (MIAMI) cells, a unique population of postnatal young and old human cells with extensive expansion and differentiation potential. J. Cell Sci. 117: 2971-2981.
Research Team:Principal Investigator, Dr. Paul Schiller is jointly appointed at the Miami VA Medical Center and University of Miami. His research focuses on hormonal regulation of mature and developing skeletal cells, and the stem cell biology of marrow-derived human pluripotent cells during aging and their reparative medicine applications.


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