Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.

ABSTRACT: 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_1c  ≤ 6.5% or reduced by ≥ 1 percentage point at 1 year posttransplant. Median HbA_1c declined from 8.1% before to

SUBMITTER: Markmann JF 

PROVIDER: S-EPMC9074710 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature