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Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.
Witkowski P, Philipson LH, Buse JB, Robertson RP, Alejandro R, Bellin MD, Kandeel F, Baidal D, Gaglia JL, Posselt AM, Anteby R, Bachul PJ, Al-Salmay Y, Jayant K, Perez-Gutierrez A, Barth RN, Fung JJ, Ricordi C. Witkowski P, et al. Among authors: gaglia jl. Front Endocrinol (Lausanne). 2022 Jan 6;12:789526. doi: 10.3389/fendo.2021.789526. eCollection 2021. Front Endocrinol (Lausanne). 2022. PMID: 35069442 Free PMC article.
The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.
Witkowski P, Philipson LH, Kaufman DB, Ratner LE, Abouljoud MS, Bellin MD, Buse JB, Kandeel F, Stock PG, Mulligan DC, Markmann JF, Kozlowski T, Andreoni KA, Alejandro R, Baidal DA, Hardy MA, Wickrema A, Mirmira RG, Fung J, Becker YT, Josephson MA, Bachul PJ, Pyda JS, Charlton M, Millis JM, Gaglia JL, Stratta RJ, Fridell JA, Niederhaus SV, Forbes RC, Jayant K, Robertson RP, Odorico JS, Levy MF, Harland RC, Abrams PL, Olaitan OK, Kandaswamy R, Wellen JR, Japour AJ, Desai CS, Naziruddin B, Balamurugan AN, Barth RN, Ricordi C; “Islets for US” Collaborative. Witkowski P, et al. Among authors: gaglia jl. Am J Transplant. 2021 Apr;21(4):1365-1375. doi: 10.1111/ajt.16397. Epub 2021 Feb 10. Am J Transplant. 2021. PMID: 33251712 Free PMC article.
Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting.
Witkowski P, Odorico J, Pyda J, Anteby R, Stratta RJ, Schrope BA, Hardy MA, Buse J, Leventhal JR, Cui W, Hussein S, Niederhaus S, Gaglia J, Desai CS, Wijkstrom M, Kandeel F, Bachul PJ, Becker YT, Wang LJ, Robertson RP, Olaitan OK, Kozlowski T, Abrams PL, Josephson MA, Andreoni KA, Harland RC, Kandaswamy R, Posselt AM, Szot GL, Ricordi C, On Behalf Of The Islets For Us Collaborative. Witkowski P, et al. J Clin Med. 2021 Jun 29;10(13):2878. doi: 10.3390/jcm10132878. J Clin Med. 2021. PMID: 34209541 Free PMC article.
Time to Peak Glucose and Peak C-Peptide During the Progression to Type 1 Diabetes in the Diabetes Prevention Trial and TrialNet Cohorts.
Voss MG, Cuthbertson DD, Cleves MM, Xu P, Evans-Molina C, Palmer JP, Redondo MJ, Steck AK, Lundgren M, Larsson H, Moore WV, Atkinson MA, Sosenko JM, Ismail HM; DPT-1 and TrialNet Study Groups. Voss MG, et al. Diabetes Care. 2021 Oct;44(10):2329-2336. doi: 10.2337/dc21-0226. Epub 2021 Aug 6. Diabetes Care. 2021. PMID: 34362815 Free PMC article. Clinical Trial.
Islet transplantation: progress and challenge.
Gaglia JL, Shapiro AM, Weir GC. Gaglia JL, et al. Arch Med Res. 2005 May-Jun;36(3):273-80. doi: 10.1016/j.arcmed.2005.03.014. Arch Med Res. 2005. PMID: 15925017 Review.
IL-6 receptor blockade does not slow β cell loss in new-onset type 1 diabetes.
Greenbaum CJ, Serti E, Lambert K, Weiner LJ, Kanaparthi S, Lord S, Gitelman SE, Wilson DM, Gaglia JL, Griffin KJ, Russell WE, Raskin P, Moran A, Willi SM, Tsalikian E, DiMeglio LA, Herold KC, Moore WV, Goland R, Harris M, Craig ME, Schatz DA, Baidal DA, Rodriguez H, Utzschneider KM, Nel HJ, Soppe CL, Boyle KD, Cerosaletti K, Keyes-Elstein L, Long SA, Thomas R, McNamara JG, Buckner JH, Sanda S; ITN058AI EXTEND Study Team. Greenbaum CJ, et al. Among authors: gaglia jl. JCI Insight. 2021 Nov 8;6(21):e150074. doi: 10.1172/jci.insight.150074. JCI Insight. 2021. PMID: 34747368 Free PMC article. Clinical Trial.
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Marso SP, et al. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13. N Engl J Med. 2016. PMID: 27295427 Free PMC article. Clinical Trial.
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