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Phase 3 trial of hu...
Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
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- Markmann, James F. (author)
- Harvard Med Sch, Div Transplant Surg, Massachusetts Gen Hosp, Boston, MA 02115 USA.
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- Rickels, Michael R. (author)
- Univ Penn, Div Endocrinol Diabet & Metab, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA.
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- Eggerman, Thomas L. (author)
- NIDDK, NIH, Bethesda, MD 20892 USA.
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- Bridges, Nancy D. (author)
- NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
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- Lafontant, David E. (author)
- Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
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- Qidwai, Julie (author)
- Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
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- Foster, Eric (author)
- Ferring Pharmaceut, Parsippany, NJ USA.
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- Clarke, William R. (author)
- Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
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- Kamoun, Malek (author)
- Univ Penn, Perelman Sch Med, Dept Pathol & Lab Med, Philadelphia, PA 19104 USA.
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- Alejandro, Rodolfo (author)
- 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.
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- Bellin, Melena D. (author)
- Univ Minnesota, Dept Endocrinol, Minneapolis, MN USA.
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- Chaloner, Kathryn (author)
- Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
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- Czarniecki, Christine W. (author)
- NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
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- Goldstein, Julia S. (author)
- NIAID, NIH, 9000 Rockville Pike, Bethesda, MD 20892 USA.
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- Hering, Bernhard J. (author)
- Univ Minnesota, Schulze Diabet Inst, Minneapolis, MN USA.;Univ Minnesota, Dept Surg, Box 242 UMHC, Minneapolis, MN 55455 USA.
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- Hunsicker, Lawrence G. (author)
- Univ Iowa, Clin Trials Stat & Data Management Ctr, Iowa City, IA USA.
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- Kaufman, Dixon B. (author)
- Univ Wisconsin, Dept Surg, Div Transplantat, Madison, WI USA.
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- Korsgren, Olle (author)
- Uppsala universitet,Klinisk immunologi
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- Larsen, Christian P. (author)
- Emory Univ, Emory Transplant Ctr, Atlanta, GA 30322 USA.
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- Luo, Xunrong (author)
- Duke Univ, Dept Med, Durham, NC USA.
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- Naji, Ali (author)
- Univ Penn, Perelman Sch Med, Dept Surg, Div Transplantat, Philadelphia, PA 19104 USA.
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- Oberholzer, Jose (author)
- Univ Illinois, Dept Surg, Chicago, IL 60680 USA.
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- Posselt, Andrew M. (author)
- Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.
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- Ricordi, Camillo (author)
- 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.
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- Senior, Peter A. (author)
- Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.
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- Shapiro, A. M. James (author)
- Univ Alberta, Clin Islet Transplant Program, Edmonton, AB, Canada.;Univ Alberta, Fac Med & Dent, Edmonton, AB, Canada.
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- Stock, Peter G. (author)
- Univ Calif San Francisco, Dept Surg, San Francisco, CA USA.
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- Turgeon, Nicole A. (author)
- Univ Texas Med Sch, Dept Surg, Austin, TX USA.
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Harvard Med Sch, Div Transplant Surg, Massachusetts Gen Hosp, Boston, MA 02115 USA Univ Penn, Div Endocrinol Diabet & Metab, Perelman Sch Med, Dept Med, Philadelphia, PA 19104 USA. (creator_code:org_t)
- John Wiley & Sons, 2021
- 2021
- English.
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In: American Journal of Transplantation. - : John Wiley & Sons. - 1600-6135 .- 1600-6143. ; 21:4, s. 1477-1492
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- basic (laboratory) research
- science
- clinical research
- practice
- diabetes
- type 1
- islet transplantation
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Markmann, James ...
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Rickels, Michael ...
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Eggerman, Thomas ...
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Bridges, Nancy D ...
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Lafontant, David ...
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Qidwai, Julie
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Foster, Eric
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Clarke, William ...
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Kamoun, Malek
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Alejandro, Rodol ...
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Bellin, Melena D ...
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Chaloner, Kathry ...
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Czarniecki, Chri ...
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Goldstein, Julia ...
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Hering, Bernhard ...
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Hunsicker, Lawre ...
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Kaufman, Dixon B ...
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Korsgren, Olle
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Larsen, Christia ...
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Luo, Xunrong
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Naji, Ali
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Oberholzer, Jose
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Posselt, Andrew ...
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Ricordi, Camillo
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Senior, Peter A.
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Shapiro, A. M. J ...
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Stock, Peter G.
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Turgeon, Nicole ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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American Journal ...
- By the university
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Uppsala University