oa Editorial: Effective Bio-EconomicApproaches for StemCell Therapy and Regenerative Medicine

The advent of regenerative medicine holds a high degree of promise against serious human and animal diseases, dysfunctions and injuries, and has been a hallmark of this century with a lot of expectations perceived by international communities regarding its true integration within modern medicine, especially the one encompassing stem cell technologies, therapeutics and tissue engineering. The application of a variety of adult stem cells and modes of using bioengineering technologies to repair and build tissues/organs, respectively, has initiated a world-wide, fast-paced, competitive run for profitable outcomes in diagnostics and potential therapeutics for degenerative diseases, including heart disease, diabetes, cancer, bone, soft-tissue and cartilage regeneration, Parkinson's, stroke, and several other human and animal malfunctions. Although, adult stem cells and their effective use in bone marrow transplantation, leukemia, corneal disorders, and burns, are well known, the general field has been further explored in the last decade with the introduction of tissue engineered organs with the use of primary cells in patients and further scope in other varieties of animal and human diseases. In addition, functional adult stem cells can now be easily obtained from a variety of adult tissue and organ sources. The field is further complicated with the introduction of the relatively newer cell types, including embryonic stem cells and induced pluripotent cells which have been described as having a higher degree of plasticity and pluripotency than adult stem cells. The complexity is further compounded with hurdles of ethical and political debates, proof of concept and development studies with a critical need for serious consolidation approaches, and practical applications in human and animal diseases. The current challenges facing regenerative medicine field consist of how these varieties of cutting-edge technologies and innovative therapeutics can be quickly evaluated for their safety and functional efficacies and brought into main-stream utilization mode against specific human and animal-related dysfunctions and degenerative diseases. National Regenerative Medicine Fund to support regenerative medicine applications and development of effective clinical studies in a cost-effective and time-sensitive manner. There is a dire need for implementing effective analytical tools that will help to grade the potentials of regenerative medicine in a cost and time critical manner. The field is fragmented and confusing with many regulatory hurdles and similar types of early-stage clinical trials. Currently there are established guidelines for clinical regenerative medicine-translation research within the US, and other countries have also attempted to have their own regulated regenerative medicine approaches, but these systems are often sub-optimal because of non-focused scientific planning and insufficient financial support and budgeting mechanisms. The biggest challenges facing the regenerative medicine field are how to effectively convert proof of concept studies into functionally productive preclinical and clinical studies, which are costly, challenging and time-consuming. How can there be a system implemented to clearly determine the go-no-go decision/s for potential regenerative medicine therapeutics? The solution could be as simple as forming independent national funds that would include several components, including, (1) Federal funding track, (2) Private funding track and (3) Federal-private funding track in key, defined areas. Tax incentives could be applied for the private funding sources. The fund could be governed under the recommendations of a committee with a pre-designated number of members with expert representation from interested sectors, such as Research and Development, Clinical Research, Biotechnology, Venture Capital/ Private Equity, and the specific applicable national regulatory agency. These committees could be designed with multiple tracks, for example, (1) regenerative medicine cell therapy, (2) Tissue Engineering and (3) Miscellaneous/Combination/Other regenerative medicine approaches. A biannual cycle would be in place for submission of proposals potentially with matured projects needing financial support and scientific, regulatory, manufacturing, and clinical guidance. The final decision to support the proposals would be recommended by the committee. In addition, the committee members would have a three year term with replacement by experts in the required fields. This bio-economic, regenerative medicine funding approach could identify and support translational projects and help with costs supporting the manufacturing and clinical studies. The goal would be to achieve a more expedient route to accomplish safety and efficacy on potential regenerative medicine therapeutics and carve cost-effective mechanisms for their use toward larger market penetrations with higher return on investment for the federal and private funding tracks. This in addition will open doors for new hires, advance entrepreneurship/s, and initiate product-oriented and commercial business expansion for further regenerative medicine opportunities. The specific model used for funding projects in the stem cell and regenerative medicine field is not as important as the concept of doing so in a proactive manner. Larger investments in the field would lead to faster advances, and new models would explored.