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Review
. 2021 Mar;16(3):309-322.
doi: 10.2217/rme-2020-0178. Epub 2021 Feb 24.

Regenerative medicine clinical readiness

Satsuki Yamada  1   2 , Atta Behfar  1   3 , Andre Terzic  1   4
Affiliations
Review

Regenerative medicine clinical readiness

Satsuki Yamada et al. Regen Med. 2021 Mar.

Abstract

Regenerative medicine, poised to transform 21st century healthcare, has aspired to enrich care options by bringing cures to patients in need. Science-driven responsible and regulated translation of innovative technology has enabled the launch of previously unimaginable care pathways adopted prudently for select serious diseases and disabilities. The collective resolve to advance the design, manufacture and validity of affordable regenerative solutions aims to democratize such health benefits for all. The objective of this Review is to outline the framework and prerequisites that underpin clinical readiness of regenerative care. Integrated research and development, specialized workforce education and accessible evidence-based practice implementation are at the core of realizing an equitable regenerative medicine vision.

Keywords: chronic disease; healthcare delivery; innovation; manufacturing; model of care; patient; population; practice; regeneration; regulation; supply chain; workforce.

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Conflict of interest statement

Financial & competing interests disclosure

The authors are supported by the National Institutes of Health (R01 HL134664), Marriott Family Foundation, Van Cleve Cardiac Regenerative Medicine Program, Michael S. and Mary Sue Shannon Family, and Center for Regenerative Medicine at Mayo Clinic. S Yamada, A Behfar and A Terzic are coinventors on regenerative sciences related intellectual property disclosed to Mayo Clinic. Previously, Mayo Clinic has administered research grants from Celyad. Mayo Clinic, A Behfar and A Terzic have interests in Rion LLC. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1.
Figure 1.. Regenerative medicine perspective.
Regenerative medicine is a driver of the healthcare future. Supported by the rigor of research and executed by an educated workforce, regenerative medicine brings innovative and validated cures to the practice, addressing needs of patients and population.
Figure 2.
Figure 2.. Healthcare evolution.
The traditional ‘care’ model, underpinning the medicine of fighting disease and mitigating disease symptoms, is poised to transition into an increasingly ‘curative’ counterpart equipped to rebuild health.
Figure 3.
Figure 3.. Regenerative medicine aspiration.
Conceived to be agnostic to the therapeutic modality utilized, the overarching regenerative medicine aspiration embodies the ‘P3’ paradigm encompassing the ‘prevent-protect-promote’ attributes directed to retain wellness, restore form and rebuild function, ultimately reimagining the healthcare horizon.
Figure 4.
Figure 4.. Regenerative care readiness.
Driven by unmet patient needs and enabled by a maturing technological and translational, new services lines are realized across regenerative medicine-intense care pathways. A permissive ecosystem, encompassing patient/public awareness, regulatory approval and care access/affordability, underpins long-term success in advancing a curative model of care.
Figure 5.
Figure 5.. Regenerative medicine-catalyzed rebalancing.
To reconcile the misbalance between a disease burdened as opposed to a disease-free life is the purpose of regenerative medicine.
Figure 6.
Figure 6.. Practice uptake.
Adoption by practice requires confluence of complementary levers. These range from innovation stringency, responsible translation and regulatory harmonization to supply chain implementation, advanced access and scalable/standardize delivery, with the express purpose of ensuring therapeutic value.
See this image and copyright information in PMC

References

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