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FältnamnIndikatorerMetadata
00006131naa a2200685 4500
001oai:DiVA.org:uu-450607
003SwePub
008210817s2021 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4506072 URI
0247 a https://doi.org/10.1111/ajt.161742 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Markmann, James F.u Harvard Med Sch, Div Transplant Surg, Massachusetts Gen Hosp, Boston, MA 02115 USA.4 aut
2451 0a Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
264 1b John Wiley & Sons,c 2021
338 a print2 rdacarrier
520 a Allogeneic islet transplant offers a minimally invasive option for beta cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplant (CIT06), a National Institutes of Health-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy. PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events and HbA(1c) <= 6.5% or reduced by >= 1 percentage point at 1 year posttransplant. Median HbA(1c)declined from 8.1% before to 6.0% at 1 year and 6.3% at 2 and 3 years following transplant (P < .001 for all vs baseline), with related improvements in hypoglycemia awareness and glucose variability. The improved metabolic control was associated with better health-related and diabetes-related quality of life. The procedure was safe and kidney allograft function remained stable after 3 years. These results add to evidence establishing allogeneic islet transplant as a safe and effective treatment for patients with T1D and unstable glucose control despite intensive insulin treatment, supporting the indication for PHPI in the post-renal transplant setting.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng
653 a basic (laboratory) research
653 a science
653 a clinical research
653 a practice
653 a diabetes
653 a type 1
653 a islet transplantation
7001 a Rickels, Michael R.u Univ Penn, Div Endocrinol Diabet & Metab, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA.4 aut
7001 a Eggerman, Thomas L.u NIDDK, NIH, Bethesda, MD 20892 USA.4 aut
7001 a Bridges, Nancy D.u NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.4 aut
7001 a Lafontant, David E.u Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.4 aut
7001 a Qidwai, Julieu Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.4 aut
7001 a Foster, Ericu Ferring Pharmaceut, Parsippany, NJ USA.4 aut
7001 a Clarke, William R.u Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.4 aut
7001 a Kamoun, Maleku Univ Penn, Perelman Sch Med, Dept Pathol & Lab Med, Philadelphia, PA 19104 USA.4 aut
7001 a Alejandro, Rodolfou Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.;Univ Miami, Miller Sch Med, Clin Cell Transplant Program, Miami, FL 33136 USA.4 aut
7001 a Bellin, Melena D.u Univ Minnesota, Dept Endocrinol, Minneapolis, MN USA.4 aut
7001 a Chaloner, Kathrynu Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.4 aut
7001 a Czarniecki, Christine W.u NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.4 aut
7001 a Goldstein, Julia S.u NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.4 aut
7001 a Hering, Bernhard J.u Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.4 aut
7001 a Hunsicker, Lawrence G.u Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.4 aut
7001 a Kaufman, Dixon B.u Univ Wisconsin, Dept Surg, Div Transplantat, Madison, WI USA.4 aut
7001 a Korsgren, Olleu Uppsala universitet,Klinisk immunologi4 aut0 (Swepub:uu)ollekors
7001 a Larsen, Christian P.u Emory Univ, Emory Transplant Ctr, Atlanta, GA 30322 USA.4 aut
7001 a Luo, Xunrongu Duke Univ, Dept Med, Durham, NC USA.4 aut
7001 a Naji, Aliu Univ Penn, Perelman Sch Med, Dept Surg, Div Transplantat, Philadelphia, PA 19104 USA.4 aut
7001 a Oberholzer, Joseu Univ Illinois, Dept Surg, Chicago, IL 60680 USA.4 aut
7001 a Posselt, Andrew M.u Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.4 aut
7001 a Ricordi, Camillou Univ Miami, Miller Sch Med, Diabet Res Inst, Miami, FL 33136 USA.;Univ Miami, Miller Sch Med, Clin Cell Transplant Program, Miami, FL 33136 USA.4 aut
7001 a Senior, Peter A.u Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.4 aut
7001 a Shapiro, A. M. Jamesu Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.4 aut
7001 a Stock, Peter G.u Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.4 aut
7001 a Turgeon, Nicole A.u Univ Texas Med Sch, Dept Surg, Austin, TX USA.4 aut
7102 a Harvard Med Sch, Div Transplant Surg, Massachusetts Gen Hosp, Boston, MA 02115 USA.b Univ Penn, Div Endocrinol Diabet & Metab, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA.4 org
7730 t American Journal of Transplantationd : John Wiley & Sonsg 21:4, s. 1477-1492q 21:4<1477-1492x 1600-6135x 1600-6143
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-450607
8564 8u https://doi.org/10.1111/ajt.16174

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