Allogeneic islet cell transplantation (ICT) can be an effective therapy for many patients with brittle type 1 diabetes, as it may reestablish hypoglycemic awareness and better attain optimal glycemic control. The ICT program at the University of Illinois at Chicago (UIC) began in 2004 and we herein present the summary of all patients’ outcomes to date. The 43 patients receiving ICT at UIC include 10 patients in the phase1/2 trial, 20 patients in the phase 3 trial, 10 patients in the Clinical Islet Transplant Consortium trials (CIT-02, n=2; CIT-06, n=4; CIT-07, n=4), and 3 University of Chicago patients transplanted with islets manufactured at UIC. Overall, the sample had a mean baseline age of 46.7 years, BMI 23.4, HbA1c 7.4%, and insulin dose 0.48 units/kg/day, and 74.4% were female, and 95.3% Non-Hispanic white. Single ICTs were performed in n=18, two ICTs in n=18, and three ICTs in n=7. Thirty seven completed 1-year follow-up after last ICT. The following results at 1-year post-last ICT are presented respectively for the phase 1/2 trial (21 ICTs), phase 3 trial (35 ICTs), and supplemental group (CIT and University of Chicago; 19 ICTs). The primary outcome of attaining both an HbA1c ≤6.5%, and no severe hypoglycemic episodes (SHEs) between 1-month and 1-year post-last ICT, was achieved in: 90%, 50%, and 54%. Insulin independence was attained in: 80%, 60%, and 54%. Graft failure occurred in: 0%, 25%, and 39%. In the two UIC trials combined, HbA1c decreased from 7.4% at baseline to 6.0%; and SHEs decreased from 1.0/month at baseline to 0.1/month. At 5-years post-last ICT in the two UIC trials, 11 of 15 (73.3%) still met the criteria for a successful primary outcome. In terms of safety, the frequency of serious adverse events across the three groups, respectively, were: 50%, 50%, and 54%. Despite the documented risks of ICT for type 1 diabetes primarily due to the chronic use of immunosuppression, many patients may potentially benefit in terms of eliminating SHEs and optimizing glycemic control.
K.K. Danielson: None. Y. Li: None. J. Oberholzer: Research Support; Self; JDRF. Stock/Shareholder; Self; Sigilon Therapeutics. Other Relationship; Self; CellTrans Inc., Sigilon Therapeutics.
American Diabetes Association (1-16-ICTS-022 to K.K.D.); National Institutes of Health (U42RR023245, UL1RR029879, UC4DK114839, U01DK070431, R01DK091526)