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Ethical and Policy Issues in Practices of Regenerative Medicine for the Treatment of Chronic Pain

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Essentials of Regenerative Medicine in Interventional Pain Management

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Abstract

There is growing evidence for application of various biologicals in the form of regenerative medicine for numerous musculoskeletal and spine disorders. While the debate continues on the appropriateness of use of these modalities in managing chronic pain of musculoskeletal and spinal disorders, scientific evidence continues to grow. Among the multiple modalities available, platelet-rich plasma (PRP), bone marrow concentrate (BMC), and application of fat cells in managing these disorders have continuously been debated. PRP is the non-controversial modality of treatment, whereas growth factors derived from adipose-derived stem cells with application of enzymes has been a controversial issue opposed by the Food and Drug Administration (FDA).

In application of biologics for musculoskeletal and spine disorders, there are multiple issues related to scientific/technical aspects and generated by social factors, circumstances, and concerns, and are not mutually exclusive, but rather are interactive. Issues inherent to science and technology are focal to safety, efficacy, clinical effectiveness, and cost. Costs and value contribute to and reflect need, demand, and provision (i.e., which patients will receive these state-of-the-art technologies, and the methods with which such questions about the allocation of resources can/should be addressed and resolved). In this chapter, ethical and policy issues in practices of regenerative medicine for the treatment of chronic pain are addressed.

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Acknowledgments

This work was supported in part by federal funds UL1TR001409 from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards Program (CTSA), a trademark of the Department of Health and Human Services, part of the Roadmap Initiative, “Re-Engineering the Clinical Research Enterprise” (JG); the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement 720270: HBP SGA1 (JG); the AEHS Foundation Project Neuro-HOPE (JG); an unrestricted research grant from Fortuna Fix Inc. (JG), and by the Austin and Ann O’Malley Distinguished Visiting Chair in Bioethics of Loyola Marymount University (JG).

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Authors and Affiliations

  1. Department of Philosophy and Science Education, University of Buffalo, Buffalo, NY, USA

    John R. Shook

  2. Departments of Neurology and Biochemistry, Chief of Neuroethics Studies Program, Pellegrino Center for Clinical Bioethics, Georgetown University Medical Center, Washington, DC, USA

    James Giordano

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  1. John R. Shook
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Correspondence to James Giordano .

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Editors and Affiliations

  1. Comprehensive Spine & Sports Center, Campbell, CA, USA

    Annu Navani

  2. Tri-State Spine Care Institute, Cincinnati, OH, USA

    Sairam Atluri

  3. Pain Management Centers Of America, Evansville, IN, USA

    Mahendra Sanapati

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Shook, J.R., Giordano, J. (2024). Ethical and Policy Issues in Practices of Regenerative Medicine for the Treatment of Chronic Pain. In: Navani, A., Atluri, S., Sanapati, M. (eds) Essentials of Regenerative Medicine in Interventional Pain Management. Springer, Cham. https://doi.org/10.1007/978-3-031-50357-3_34

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  • DOI: https://doi.org/10.1007/978-3-031-50357-3_34

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