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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
Page 83
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
Page 84
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
Page 85
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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84 EXPLORING VARIABILITY IN REGENERATIVE ENGINEERING PRODUCTS Fernández-Avilés, F., R. Sanz-Ruiz, A. M. Climent, L. Badimon, R. Bolli, D. Charron, V. Fuster, S. Janssens, J. Kastrup, H. Kim, T. F. Lüscher, J. F. Martin, P. Menasché, R. D. Simari, G. W. Stone, A. Terzic, J. T. Willerson, J. C. Wu, and the TACTICS (Transnational Alli­ ance for Regenerative Therapies in Cardiovascular Syndromes) writing group. 2017. Global position paper on cardiovascular regenerative medicine. European Heart Journal 38(33):2532–2546. Florea, V., A. C. Rieger, D. L. DiFede, J. El-Khorazaty, M. Natsumeda, M. N. Banerjee, B. A. Tompkins, A. Khan, I. H. Schulman, A. M. Landin, M. Mushtaq, S. Golpanian, M. H. Lowery, J. J. Byrnes, R. C. Hendel, M. G. Cohen, K. Valasaki, M. V. Pujol, E. Ghersin, R. Miki, C. Delgado, F. Abuzeid, M. Vidro-Casiano, R. G. Saltzman, D. DaFonseca,­ L. V. Caceres, K. N. Ramdas, A. Mendizabal, A. W. Heldman, R. D. Mitrani, and J. M. Hare. 2017. Dose comparison study of allogeneic mesenchymal stem cells in patients with ­ ischemic cardiomyopathy (the TRIDENT study). Circulation Research 121(11):1279–1290. Gerber, T., P. Murawala, D. Knapp, W. Masselink, M. Schuez, S. Hermann, M. Gac-Santel, S. Nowoshilow, J. Kageyama, S. Khattak, J. D. Currie, J. G. Camp, E. M. Tanaka, and B. Treutlein. 2018. Single-cell analysis uncovers convergence of cell identities during axolotl limb regeneration. Science 362(6413):0681. Grogan, B. F., J. R. Hsu, and the Skeletal Trauma Research Consortium. 2011. Volumetric­ ­muscle loss. Journal of the American Academy of Orthopedic Surgery 19(Suppl 1):S35–S37. Hare, J. M., J. E. Fishman, G. Gerstenblith, D. L. DiFede Velazquez, J. P. Zambrano, V. Y. Suncion, M. Tracy, E. Ghersin, P. V. Johnston, J. A. Brinker, E. Breton, J. Davis-Sproul, I. H. Schulman, J. Byrnes, A. M. Mendizabal, M. H. Lowery, D. Rouy, P. Altman, C. Wong Po Foo, P. Ruiz, A. Amador, J. Da Silva, I. K. McNiece, A. W. Heldman, R. George, and A. Lardo. 2012. Comparison of allogeneic vs. autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: The POSEIDON randomized trial. Journal of the American Medical Association 308(22):2369–2379. Hare, J. M., D. L. DiFede A. C. Rieger, V. Florea, A. M. Landin, J. El-Khorazaty, A. Khan, M. Mushtaq, M. H. Lowery, J. J. Byrnes, R. C. Hendel, M. G. Cohen, C. E. Alfonso, K. Valasaki, M. V. Pujol, S. Golpanian, E. Ghersin, J. E. Fishman, P. Pattany, S. A. Gomes, C. Delgado, R. Miki, F. Abuzeid, M. Vidro-Casiano, C. Premer, A. Medina, V. Porras, K. E. Hatzistergos, E. Anderson, A. Mendizabal, R. Mitrani, and A. W. Heldman. 2017. Randomized comparison of allogeneic versus autologous mesenchymal stem cells for nonischemic dilated cardiomyopathy: POSEIDON-DCM Trial. Journal of the American College of Cardiology 69(5):526–537. Heldman, A. W., D. L. DiFede, J. E. Fishman, J. P. Zambrano, B. H. Trachtenberg, V. K ­ arantalis, M. Mushtaq, A. R. Williams, V. Y. Suncion, I. K. McNiece, E. Ghersin, V. Soto, G. Lopera, R. Miki, H. Willens, R. Hendel, R. Mitrani, P. Pattany, G. Feigenbaum, B. Oskouei, J. Byrnes, M. H. Lowery, J. Sierra, M. V. Pujol, C. Delgado, P. J. Gonzalez, J. E. Rodriguez, L. L. Bagno, D. Rouy, P. Altman, C. W. Foo, J. da Silva, E. Anderson, R. Schwarz, A. Mendizabal, and J. M. Hare. 2014. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: The TAC-HFT randomized trial. Journal of the American Medical Association 311(1):62–73. Jessop, Z. M., A. Al-Sabah, W. R. Francis, and I. S. Whitaker. 2016. Transforming healthcare through regenerative medicine. BMC Medicine 14(1):115. Karantalis, V., and J. M. Hare. 2015. Use of mesenchymal stem cells for therapy of cardiac disease. Circulation Research 116(8):1413–1430. PREPUBLICATION COPY­ Uncorrected Proofs —

REFERENCES 85 Karantalis, V., D. L. DiFede, G. Gerstenblith, S. Pham, J. Symes, J. P. Zambrano, J. Fishman, P. Pattany, I. McNiece, J. Conte, S. Schulman, K. Wu, A. Shah, E. Breton, J. Davis-Sproul, R. Schwarz, G. Feigenbaum, M. Mushtaq, V. Y. Suncion, A. C. Lardo, I. Borrello, A. Mendizabal, T. Z. Karas, J. Byrnes, M. Lowery, A. W. Heldman, and J. M. Hare. 2014. Autologous mesenchymal stem cells produce concordant improvements in regional func- tion, tissue perfusion, and fibrotic burden when administered to patients undergoing coronary artery bypass grafting: The Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) trial. ­ irculation Research 114(8):1302–1310. C Karantalis, V., V. Y. Suncion-Loescher, L. Bagno, S. Golpanian, A. Wolf, C. Sanina, C. Premer, A. J. Kanelidis, F. McCall, B. Wang, W. Balkan, J. Rodriguez, M. Rosado, A. Morales, K. Hatzistergos, M. Natsumeda, I. Margitich, I. H. Schulman, S. A. Gomes, M. Mushtaq, D. L. DiFede, J. E. Fishman, P. Pattany, J. P. Zambrano, A. W. Heldman, and J. M. Hare. 2015. Synergistic effects of combined cell therapy for chronic ischemic cardiomyopathy. Journal of the American College of Cardiology 66(18):1990–1999. Laurencin, C. T., and Y. Khan. 2012. Regenerative engineering. Science Translational Medicine 4(160):160ed9. Manuchehrabadi, N., Z. Gao Z, J. Zhang, H. L. Ring, Q. Shao, F. Liu, M. McDermott, A. Fok, Y. Rabin, K. G. Brockbank, M. Garwood, C. L. Haynes, and J. C. Bischof. 2017. Improved tissue cryopreservation using inductive heating of magnetic nanoparticles. Sci- ence Translational Medicine 9(379):eaah4586. Marks, P., and S. Gottlieb. 2018. Balancing safety and innovation for cell-based regenerative medicine. New England Journal of Medicine 378(10):954–959. Menasché, P., V. Vanneaux, A. Hagège, A. Bel, B. Cholley, I. Cacciapuoti, A. Parouchev, N. Benhamouda, G. Tachdjian, L. Tosca, J. H. Trouvin, J. R. Fabreguettes, V. Bellamy, R. Guillemain, C. Suberbielle Boissel, E. Tartour, M. Desnos, and J. Larghero. 2015. Human embryonic stem cell–derived cardiac progenitors for severe heart failure treatment: First clinical case report. European Heart Journal 36(30):2011–2017. Muschler, G. F., C. Boehm, and K. Easley. 1997. Aspiration to obtain osteoblast progenitor cells from human bone marrow: The influence of aspiration volume. Journal of Bone and Joint Surgery, American edition 79(11):1699–1709. Muschler, G. F., R. J. Midura, and C. Nakamoto. 2003. Practical modeling concepts for con- nective tissue stem cell and progenitor compartment kinetics. Journal of Biomedicine and Biotechnology 2003(3):170–193. Nguyen, P. K., E. Neofytou, J. W. Rhee, and J. C. Wu. 2016. Potential strategies to address the major clinical barriers facing stem cell regenerative therapy for cardiovascular disease: A review. Journal of the American Medical Association Cardiology 1(8):953–962. NRC (National Research Council). 2014. Convergence: Facilitating transdisciplinary integra- tion of life sciences, physical sciences, engineering, and beyond. Washington, DC: The National Academies Press. Perin, E. C., J. T. Willerson, C. J. Pepine, T. D. Henry, S. G. Ellis, D. X. Zhao, G. V. Silva, D. Lai, J. D. Thomas, M. W. Kronenberg, A. D. Martin, R. D. Anderson, J. H. Traverse, M. S. Penn, S. Anwaruddin, A. K. Hatzopoulos, A. P. Gee, D. A. Taylor, C. R. Cogle, D. Smith, L. Westbrook, J. Chen, E. Handberg, R. E. Olson, C. Geither, S. Bowman, J. Francescon, S. Baraniuk, L. B. Piller, L. M. Simpson, C. Loghin, D. Aguilar, S. Richman, C. Zierold, J. Bettencourt, S. L. Sayre, R. W. Vojvodic, S. I. Skarlatos, D. J. Gordon, R. F. Ebert, M. Kwa, L. A. Moyé, R. D. Simari, and the Cardiovascular Cell Therapy Research Network (CCTRN). 2012. Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure: The FOCUS–CCTRN trial. Journal of the American Medical Association 307(16):1717–1726. PREPUBLICATION COPY­ Uncorrected Proofs —

86 EXPLORING VARIABILITY IN REGENERATIVE ENGINEERING PRODUCTS Powell, K. A., C. Nakamoto, S. Villarruel, C. Boehm, and G. Muschler. 2007. Quantitative image analysis of connective tissue progenitors. Analytical and Quantitative Cytology and Histology 29(2):112–121. Qadan, M. A., N. S. Piuzzi, C. Boehm, W. Bova, M. Moos, Jr., R. J. Midura, V. C. Hascall, C. Malcuit, and G. F. Muschler. 2018. Variation in primary and culture-expanded cells derived from connective tissue progenitors in human bone marrow space, bone trabecular surface, and adipose tissue. Cytotherapy 20(3):343–360. Sadtler, K., K. Estrellas, B. W. Allen, M. T. Wolf, H. Fan, A. J. Tam, C. H. Patel, B. S. Luber, H. Wang, K. R. Wagner, J. D. Powell, F. Housseau, D. M. Pardoll, and J. H. Elisseeff. 2016. Developing a pro-regenerative biomaterial scaffold microenvironment requires T helper 2 cells. Science 352(6283):366–370. Seif-Naraghi, S. B., J. Singelyn, M. A. Salvatore, K. G. Osborn, J. J. Wang, U. Sampat, O. L. Kwan, G. M. Strachan, J. Wong, P. J. Schup-Magoffin, R. L. Braden, K. Bartels, J. A. DeQuach, M. Preul, A. M. Kinsey, A. N. DeMaria, N. Dib, and K. L. Christman. 2013. Safety and efficacy of an injectable extracellular matrix hydrogel for treating myocardial infarction. Science Translational Medicine 5(173):173ra25. Sharma, A. K., M. I. Bury, N. J. Fuller, A. J. Marks, D. M. Kollhoff, M. V. Rao, P. V. Hota, D. J. Matoka, S. L. Edassery, H. Thaker, J. F. Sarwark, J. A. Janicki, G. A. Ameer, and E. Y. Cheng. 2013. Cotransplantation with specific populations of spina bifida bone marrow stem/progenitor cells enhances urinary bladder regeneration. Proceedings of the National Academy of Sciences 110(10):4003–4008. Sharp, P. A., C. L. Cooney, M. A. Kastner, J. Lees, R. Sasisekharan, M. B. Yaffe, S. N. Bhatia, T. E. Jacks, D. A. Lauffenburger, R. Langer, P. T. Hammond, and M. Sur. 2011. The third revolution: The convergence of the life sciences, physical sciences, and engineering. Cambridge, MA: Massachusetts Institute of Technology. Shelley, B. C., G. Gowing, and C. N. Svendsen. 2014. A cGMP-applicable expansion method for aggregates of human neural stem and progenitor cells derived from pluripotent stem cells or fetal brain tissue. Journal of Visualized Experiments (88):51219. Singelyn, J. M., J. A. DeQuach, S. B. Seif-Naraghi, R. B. Littlefield, P. J. Schup-Magoffin, and K. L. Christman. 2009. Naturally derived myocardial matrix as an injectable scaffold for cardiac tissue engineering. Biomaterials 30(29):5409–5416. Stroncek, D. F., J. Ren, D. W. Lee, M. Tran, S. E. Frodigh, M. Sabatino, H. Khuu, M. S. Merchant, and C. L. Mackall. 2016. Myeloid cells in peripheral blood mononuclear cell concentrates inhibit the expansion of chimeric antigen receptor T cells. Cytotherapy 18(7):893–901. Vrtovec, B., G. Poglajen, L. Lezaic, M. Sever, A. Socan, D. Domanovic, P. Cernelc, G. T ­ orre-Amione, F. Haddad, and J. C. Wu. 2013. Comparison of transendocardial and intracoronary CD34+ cell transplantation in patients with nonischemic dilated cardio- myopathy. Circulation 128(11 Suppl 1):S42–S49. Wassenaar, J. W., R. Gaetani, J. J. Garcia, R. L. Braden, C. G. Luo, D. Huang, A. N. DeMaria, J. H. Omens, and K. L. Christman. 2016. Evidence for mechanisms underlying the func- tional benefits of a myocardial matrix hydrogel for post-MI treatment. Journal of the American College of Cardiology 67(9):1074–1086. PREPUBLICATION COPY­ Uncorrected Proofs —

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The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results.

The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

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