Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
| Autor: | Melena D. Bellin, Eric D. Foster, Andrew M. Posselt, Jose Oberholzer, David Erick Lafontant, James F. Markmann, Michael R. Rickels, Bernhard J. Hering, Camillo Ricordi, Peter G. Stock, Lawrence G. Hunsicker, Thomas L. Eggerman, N Turgeon, A. M. James Shapiro, Christian P. Larsen, Ali Naji, Kathryn Chaloner, Julie Qidwai, Christine W. Czarniecki, Nancy D. Bridges, Olle Korsgren, Xunrong Luo, Rodolfo Alejandro, Julia S. Goldstein, William R. Clarke, Peter A. Senior, Malek Kamoun, Dixon B. Kaufman |
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| Rok vydání: | 2021 |
| Předmět: |
Blood Glucose
medicine.medical_specialty endocrine system diseases medicine.medical_treatment Islets of Langerhans Transplantation 030230 surgery Hypoglycemia 03 medical and health sciences 0302 clinical medicine Internal medicine Diabetes mellitus medicine Clinical endpoint Humans Insulin Immunology and Allergy Pharmacology (medical) Prospective Studies Transplantation Type 1 diabetes geography geography.geographical_feature_category business.industry Pancreatic islets medicine.disease Islet Kidney Transplantation Diabetes Mellitus Type 1 medicine.anatomical_structure Quality of Life business |
| Zdroj: | American Journal of Transplantation. 21:1477-1492 |
| ISSN: | 1600-6135 |
| DOI: | 10.1111/ajt.16174 |
| Popis: | 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 HbA1c ≤ 6.5% or reduced by ≥ 1 percentage point at 1 year posttransplant. Median HbA1c declined from 8.1% before to 6.0% at 1 year and 6.3% at 2 and 3 years following transplant (P |
| Databáze: | OpenAIRE |
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