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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: anteby r. 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.
Post-Hoc Analysis of a Randomized, Double Blind, Prospective Study at the University of Chicago: Additional Standardizations of Trial Protocol are Needed to Evaluate the Effect of a CXCR1/2 Inhibitor in Islet Allotransplantation.
Bachul PJ, Golab K, Basto L, Zangan S, Pyda JS, Perez-Gutierrez A, Borek P, Wang LJ, Tibudan M, Tran DK, Anteby R, Generette GS, Chrzanowski J, Fendler W, Perea L, Jayant K, Lucander A, Thomas C, Philipson L, Millis JM, Fung J, Witkowski P. Bachul PJ, et al. Among authors: anteby r. Cell Transplant. 2021 Jan-Dec;30:9636897211001774. doi: 10.1177/09636897211001774. Cell Transplant. 2021. PMID: 33908301 Free PMC article. Clinical Trial.
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. Among authors: anteby r. J Clin Med. 2021 Jun 29;10(13):2878. doi: 10.3390/jcm10132878. J Clin Med. 2021. PMID: 34209541 Free PMC article.
[No title available]
[No authors listed] [No authors listed] PMID: 34908299
BETA-2 score is an early predictor of graft decline and loss of insulin independence after pancreatic islet allotransplantation.
Bachul PJ, Gołębiewska JE, Basto L, Gołąb K, Anteby R, Wang LJ, Tibudan M, Thomas C, Fendler W, Lucander A, Grybowski DJ, Dębska-Ślizień A, Fung J, Witkowski P. Bachul PJ, et al. Among authors: anteby r. Am J Transplant. 2020 Mar;20(3):844-851. doi: 10.1111/ajt.15645. Epub 2019 Nov 13. Am J Transplant. 2020. PMID: 31597009 Free article.
En bloc liver and pancreas transplantation after total pancreatectomy with autologous islet transplantation.
Generette GS, Bachul PJ, Golab K, Basto L, Pyda JS, Borek P, Tibudan M, Anteby R, Perea L, Charlton M, Perez-Gutierrez A, Jayant K, Lucander A, Matthews JB, Millis JM, Fung J, Witkowski P. Generette GS, et al. Among authors: anteby r. Eur J Transl Clin Med. 2020;3(2):11-17. doi: 10.31373/ejtcm/130187. Epub 2020 Nov 23. Eur J Transl Clin Med. 2020. PMID: 33409500 Free PMC article.
Total pancreatectomy with islet autotransplantation in diabetic and pre-diabetic patients with intractable chronic pancreatitis.
Bachul PJ, Grybowski DJ, Anteby R, Basto L, Perea L, Golab K, Wang LJ, Tibudan M, Perez-Gutierrez A, Komorniczak M, Nagpal S, Lucander A, Fung J, Matthews JB, Witkowski P. Bachul PJ, et al. Among authors: anteby r. J Pancreatol. 2020 Jun;3(2):86-92. doi: 10.1097/jp9.0000000000000048. J Pancreatol. 2020. PMID: 33005475 Free PMC article.
Pancreatic Islets Quality and Potency Cannot be Verified as Required for Drugs: Reflection on the FDA Review of a Biological License Application for Human Islets.
Witkowski P, Anteby R, Olaitan OK, Forbes RC, Niederhaus S, Ricordi C, Fair JH, Harland RC; Islets for US Collaborative; Cell Transplantation Committee of the American Society of Transplant Surgeons (ASTS). Witkowski P, et al. Among authors: anteby r. Transplantation. 2021 Dec 1;105(12):e409-e410. doi: 10.1097/TP.0000000000003880. Transplantation. 2021. PMID: 34231527 No abstract available.
58 results