Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.
basic (laboratory) research/science
clinical research/practice
diabetes
diabetes: type 1
islet transplantation
Journal
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
ISSN: 1600-6143
Titre abrégé: Am J Transplant
Pays: United States
ID NLM: 100968638
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
revised:
19
06
2020
received:
08
05
2020
accepted:
20
06
2020
pubmed:
7
7
2020
medline:
22
6
2021
entrez:
7
7
2020
Statut:
ppublish
Résumé
Allogeneic islet transplant offers a minimally invasive option for β 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
Identifiants
pubmed: 32627352
doi: 10.1111/ajt.16174
pmc: PMC9074710
mid: NIHMS1799176
pii: S1600-6135(22)08496-9
doi:
Substances chimiques
Blood Glucose
0
Insulin
0
Types de publication
Clinical Trial, Phase III
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1477-1492Subventions
Organisme : NCRR NIH HHS
ID : M01 RR000400
Pays : United States
Organisme : University of Pennsylvania
ID : UL1TR000003
Organisme : NIAID NIH HHS
ID : U01 AI065192
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000114
Pays : United States
Organisme : Northwestern University
ID : UL1RR025741
Organisme : NIDDK NIH HHS
ID : U01 DK070460
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000003
Pays : United States
Organisme : University of Illinois at Chicago
ID : 5U01DK070431
Organisme : University of Miami
ID : U01DK070460
Organisme : NCATS NIH HHS
ID : UL1 TR000004
Pays : United States
Organisme : University of Minnesota
ID : U01AI065193
Organisme : University of Illinois at Chicago
ID : UL1TR000050
Organisme : University of Pennsylvania
ID : M01-RR00040
Organisme : University of Pennsylvania
ID : U01DK070430
Organisme : NIAID NIH HHS
ID : U01 AI089316
Pays : United States
Organisme : University of Minnesota
ID : UL1TR000114
Organisme : NIAID NIH HHS
ID : U01 AI089317
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK085531
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK070431
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000150
Pays : United States
Organisme : Emory University
ID : UL1TR000454
Organisme : University of Minnesota
ID : M01-RR000400
Organisme : Northwestern University
ID : UL1TR000150
Organisme : NCRR NIH HHS
ID : M01 RR000040
Pays : United States
Organisme : Northwestern University
ID : U01AI089316
Organisme : NCRR NIH HHS
ID : UL1 RR025741
Pays : United States
Organisme : Uppsala Universitet
ID : U01AI065192
Organisme : NIAID NIH HHS
ID : U01 AI065191
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000050
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000454
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000460
Pays : United States
Organisme : University of Alberta
ID : U01AI065191
Organisme : Emory University
ID : U01AI089317
Organisme : NIAID NIH HHS
ID : U01 AI065193
Pays : United States
Organisme : University of California, San Francisco
ID : UL1TR000004
Organisme : University of Miami
ID : UL1TR000460
Organisme : University of California, San Francisco
ID : U01DK085531
Organisme : NIDDK NIH HHS
ID : U01 DK070430
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 The American Society of Transplantation and the American Society of Transplant Surgeons.
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