Treatment Emergent Adverse Events
| Group | Value (Participants) |
|---|---|
| Treatment | 21 |
Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataUnited States
1 trial · 1 ongoing · 1 with posted results
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
NCT006790425 Sept 2007 to est. 14 Jun 2026
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.
Experimental
Treatment
All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.
Outcomes the sponsor listed as primary.
Treatment Emergent Adverse Events
Time frame · From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year
Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
Number of Subjects Reaching the Efficacy Goal
Time frame · One year after islet transplant
A successful primary endpoint was defined as HbA1c ≤ 6.5% at the one-year follow-up visit and absence of severe hypoglycemic events (SHE) from Day 28 post-first transplant to 1 year after first and last transplant. The primary analysis was to estimate the true rate of the composite favorable outcome at 1 year following first and last transplant in patients in the ITT population.
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Time frame · 1 year after islet infusion
Number of patients presenting with insulin independence, including: Absence of exogenous insulin injection reported at Day 365. * Fasting capillary glucose level not exceeding 140 mg/dL (7.8 mmol/L) more than 3 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days. * Fasting plasma glucose level ≤ 126 mg/dL (7.0 mmol/L) at Day 365 ± 28 days (if the fasting plasma glucose level is \> 126 mg/dL \[7.0 mmol/L\], it must have been confirmed in an additional 1 out of 2 measurements). * Two-hour post-prandial capillary glucose not exceeding 180 mg/dL (10.0 mmol/L) more than 1 out of every 7 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days. * Evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥ 0.5 ng/mL (0.16 nmol/L) at Day 365 ± 28 days
Hypoglycemic Episodes by HYPO Score
Time frame · One year after the last transplant
Hypoglycemic episodes will be measured by the Ryan hypoglycemic (HYPO) Score derived from the number and severity of hypoglycemic episodes recorded throughout the follow-up phase from Day 28 to Day 365. (From Ryan et al., 2004) "A HYPO score was generated based on a combination of scores from the 4 weeks of readings and the patients' self-reported episodes over the previous year using the scoring system found in online appendix 2 (available at http://diabetes.diabetesjournals.org). The record sheets returned by the patients were analyzed for the number of episodes of glucose values recorded as \<2.5 mmol/l and between 2.5 and 2.9 mmol/l. Points were awarded if symptoms were absent or were neuroglycopenic rather than autonomic... Thus the more severe the problem with hypoglycemia, the higher the score." A Ryan score ranges from 0 (no event) to a cumulative sum of episode points of total events reported during the 4 weeks then multiplied by 13 to provide a 1-year value.
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
Time frame · One year after the first and last transplant
%reduction in Ryan HYPO Score \[%(baseline score - 1-year post transplant score)/baseline\] at time of evaluation.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Treatment | 21 |
| Group | Value (Participants) |
|---|---|
| Treatment | 8 |
| Group | Value (Participants) |
|---|---|
| Treatment | 10 |
| Group | Value (score on a scale) |
|---|---|
| Treatment | 266 |
| Group | Value (percentage of HYPO baseline) |
|---|---|
| Treatment | 66.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TreatmentAll subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans. Islets of Langerhans transplantation: Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications: Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant | 0 / 21 | 11 / 21 | 21 / 21 |
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