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Trial · Interventional

Active, not recruitingPhase 3Results postedRegistry data

Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
21 participants (actual)
Sponsor
CellTrans Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
5 Sept 2007
Primary completion
19 Jul 2017
Completion
14 Jun 2026 (estimated)
First posted
16 May 2008 (estimated)
Last update posted
6 Apr 2026
Conditions
Type 1 Diabetes Mellitus

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201520202025
  1. Ph 3

    Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

    NCT00679042

    5 Sept 2007 to est. 14 Jun 2026

Registry summary

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.

Interventions

  • Islets of Langerhans transplantationBiological

Arms1

  • Experimental

    Treatment

    All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations

  2. Number of Subjects Reaching the Efficacy Goal

    Time frame · One year after islet transplant

    Registry description

    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.

Secondary outcomes(3)
  1. Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant

    Time frame · 1 year after islet infusion

    Registry description

    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

  2. Hypoglycemic Episodes by HYPO Score

    Time frame · One year after the last transplant

    Registry description

    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.

  3. Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score

    Time frame · One year after the first and last transplant

    Registry description

    %reduction in Ryan HYPO Score \[%(baseline score - 1-year post transplant score)/baseline\] at time of evaluation.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year

Treatment Emergent Adverse Events

GroupValue (Participants)
Treatment21
Primary outcomeCount of participants· One year after islet transplant

Number of Subjects Reaching the Efficacy Goal

GroupValue (Participants)
Treatment8
Secondary and other outcome results(3)
Secondary outcomeCount of participants· 1 year after islet infusion

Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant

GroupValue (Participants)
Treatment10
Secondary outcomeMedian· One year after the last transplant

Hypoglycemic Episodes by HYPO Score

GroupValue (score on a scale)
Treatment266
Secondary outcomeMean· One year after the first and last transplant

Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score

GroupValue (percentage of HYPO baseline)
Treatment66.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 transplant0 / 2111 / 2121 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAjmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024. PMID 39735417
  • DerivedLuu QF, Villareal CJ, Fritschi C, Monson RS, Oberholzer J, Danielson KK. Concerns and hopes of patients with type 1 diabetes prior to islet cell transplantation: A content analysis. J Diabetes Complications. 2018 Jul;32(7):677-681. doi: 10.1016/j.jdiacomp.2018.04.002. Epub 2018 Apr 17. PMID 29779835

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts: * At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level \<50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration * Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of \<54 mg/dL (3 mmol/l) as reported by the subject Exclusion Criteria: * Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure * Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months) * Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication * History of non-adherence to prescribed regimens * Active infection including hepatitis C, hepatitis B, HIV * TB by history, current infection, or under treatment for suspected TB * History of malignancies except squamous or basal skin cancer * Family history of MEN2 or MCT * Stroke within the past 6 months * BMI \>27 kg/m2 * C-peptide response to glucagon stimulation, any C-peptide \>0.3 ng/mL * Inability to provide informed consent * Age less than 18 or greater than 75 years * Creatinine clearance \<80 mL/min/1.73 m2 by 24-hour urine collection * Serum creatinine consistently \>1.5 mg/dL * Macroalbuminuria \>300 mg/24h * Baseline Hb \<12 gm/dL in women, \<13 gm/dL in men * Baseline liver function tests outside normal range * Untreated proliferative retinopathy * Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast feeding * Previous transplant or PRA reactivity \>80% * Insulin requirement \>0.7 IU/kg/day * HbA1c \>12% * Hyperlipidemia (fasting cholesterol \>130 mg/dL or fasting triglycerides \>200 mg/dL * Medical condition requiring chronic use of steroids * Use of Coumadin or other antiplatelet or anticoagulant therapy, or PT-INR \>1.5 * Factor V deficiency * Smoking tobacco * Addison's disease * Allergy to radiographic contrast material * Symptomatic cholecystolithiasis * Acute or chronic pancreatitis * Symptomatic peptic ulcer disease * Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with medication absorption * Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment * Use of any study medication within 4 weeks of enrollment * Received live attenuated vaccine(s) within 2 months of enrollment * Any medical condition that, in the opinion of the investigator, might interfere with safe participation

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