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Introduction: The Promise and Challenges of Microbiome-Based Therapies

Published online by Cambridge University Press:  01 January 2021

Diane E. Hoffmann
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Type
Symposium 1 Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 4: Symposium 1 - The Promise and Challenges of Microbiome-based Therapies. Symposium 2 - Regulation on International Direct-to-Participant Genomic Research , Winter 2019 , pp. 476 - 481
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Cani, P.D., “Human Gut Microbiome: Hopes, Threats and Promises,” Gut 67, no. 9 (2018): 1716–1725.CrossRefGoogle Scholar
Kim, B. and Chun, J., “Current Status and Future Promise of the Human Microbiome,” Pediatric Gastroenterology, Hepatology and Nutrition 16, no. 2 (2013): 71–79.CrossRefGoogle Scholar
Song, Y., Wang, P., and Parian, A., et al., “Where Will Fecal Microbiota Transplantation Fit in the Treatment Algorithms for Crohn's Disease and Ulcerative Colitis: A Synthesis of Completed, Ongoing and Future Trials,” Gastroenterology 154, no. 1, Supp. (2018): S90.CrossRefGoogle Scholar
Lee, W.J., Lattimer, L.D.N., and Stephen, S., et al., “Fecal Microbiota Transplantation: A Review of Emerging Indications beyond Relapsing Clostridium difficile Toxin Colitis,” Gastroenterology and Hepatology 11, no. 1 (2015): 24–32.Google Scholar
Zhang, X. et al., “Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Rheumatoid Arthritis Refractory to Methotrexate,” ClinicalTrials.gov, available at <https://clinicaltrials.gov/ct2/show/NCT03944096> (last visited September 25, 2019).+(last+visited+September+25,+2019).>Google Scholar
Zhang, S., Palazuelos-Munoz, S., and Balsells, E.M., et al., “Cost of Hospital Management of Clostridium difficile Infection in United States — a Meta-Analysis and Modelling Study,” BMC Infectious Diseases 16 (2016): 447. doi: 10.1186/s12879-016-1786-6.CrossRefGoogle Scholar
McDonald, L.C., Gerding, D.N., and Johnson, S., et al., “Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA),” Clinical Infectious Diseases 66, no.7 (2018): e1–e48.CrossRefGoogle Scholar
Merrill, J., “Big Pharma Embraces Microbiome Research; Partnering Poised to Follow,” The Pink Sheet (April 20, 1015).Google Scholar
Myles, I.A., Williams, K.W., and Reckhow, J.D., et al., “Transplantation of Human Skin Microbiota in Models of Atopic Dermatitis,” JCI Insight 1, no. 10 (2016): e86955, available at <https://dx.doi.org/10.1172/jci.insight.86955> (last visited September 25, 2019).CrossRefGoogle Scholar
Sohn, E., “Skin Microbiota's Community Effort,” Nature 563 (2018): S91.CrossRefGoogle Scholar
Nascimento, M.M., “Oral Microbiota Transplant: A Potential New Therapy for Oral Diseases,” Journal of the California Dental Association 45, no. 10 (2017): 565–568.Google Scholar
Mårtensson, Anders et al., “Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis without Nasal Polyps (CRSsNP),” ClinicalTrials.gov, available at <https://clinical-trials.gov/ct2/show/NCT03122795> (last visited September 25, 2019).+(last+visited+September+25,+2019).>Google Scholar
U.S. Food and Drug Administration, “Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,” 78 Federal Register 42,965 (July 18, 2013).Google Scholar
U.S. Food and Drug Administration, “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies, March 2016,” available at <https://www.fda.gov/media/96562/download> (last visited September 25, 2019).+(last+visited+September+25,+2019).>Google Scholar
Id.Google Scholar
National Institutes for Allergies and Infectious Diseases, Grant No. R21AI119633.Google Scholar
The co-investigators included Hoffmann, Diane E. (PI) School of Law; Palumbo, Francic, School of Pharmacy; Ravell, Jacques, School of Medicine; and Roghman, Mary-Clair and von Rosenvinge, Eric, School of Medicine and Veteran Affairs Maryland Health Care System, Baltimore.Google Scholar
Hoffmann, D.E., Palumbo, F.B., and Ravel, J., et al., “A Proposed Definition of Microbiota Transplantation for Regulatory Purposes,” Gut Microbes 8, no. 3 (2017): 208–213; Hoffmann, D.E., Palumbo, F.B., and Ravel, J., et al., “Improving Regulation of Microbiota Transplants,” Science 358, no. 6369 (2017): 1390–1391.CrossRefGoogle Scholar
Khoruts, A., Hoffmann, D.E., and Palumbo, F.B., “The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 482–504.CrossRefGoogle Scholar
Ossorio, P. and Zhou, Y., “FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 505–523.CrossRefGoogle Scholar
Scheeler, A., “Where Stool is a Drug: International Approaches to Regulating the use of Fecal Microbiota for Transplantation,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 524–540.CrossRefGoogle Scholar
Murray, T.S. and Herbst, J., “The Ethics of Fecal Microbiota Transplant as a Tool for Antimicrobial Stewardship Programs,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 541–554.CrossRefGoogle Scholar
DeLong, K. et al., “Vaginal, “Microbiota Transplantation: The Next Frontier,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 555–567.CrossRefGoogle Scholar
Mueller, N. et al., “Bacterial Baptism: Scientific, Medical and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies,” Journal of Law, Medicine & Ethics 47, no. 4 (2019): 568–578.CrossRefGoogle Scholar