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TerminatedNCT00579371Updated Dec 21, 2023

Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus

A Phase 1/2 interventional study of Islets of Langerhans in Islets of Langerhans Transplantation and Diabetes Mellitus, Type 1, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-21.

Sponsored by University of Nebraska · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Per Coordinator: study was closed and no cadaveric implants were performed

From the registry’s dates

  • Primary completion was Mar 2011, 15 years 7 months ago, and no results have been posted to the registry.
  • Registered 3 years 9 months after the study started (first participant enrolled Mar 2004, registered Dec 2007).
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
19 Years to 70 Years
Sex
All
01

Study summary

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are:

  • Using Two-Layer method preservation to improve pancreas quality before islet isolation
  • Maintaining isolated islets in culture before transplantation
  • Using a steroid-free immunosuppression regimen
  • Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching
Read the detailed description

We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas:

using Two-Layer method preservation to improve pancreas quality before islet isolation, maintaining isolated islets in culture before transplantation, using a steroid-free immunosuppression regimen, and transplanting the best combination of donor and recipient possible after HLA screening and final crossmatching.

02

Conditions studied

  • Islets of Langerhans Transplantation
  • Diabetes Mellitus, Type 1

Keywords

  • islet transplantation
  • type 1 diabetes mellitus
  • steroid-free immunosuppression
  • rabbit anti-thymocyte globulin
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.

Browse University of Nebraska studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications:

    • Metabolic lability/instability (two or more episodes of severe hypoglycemia) or two or more hospital visits for diabetic ketoacidosis during the previous year
    • Progression of secondary complications of diabetes as determined by The Nebraska Medical Center/University of Nebraska Medical Center staff endocrinologists
  • Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression

Exclusion criteria

Exclusion Criteria:

  • Severe co-existing cardiac disease
  • Active alcohol or substance abuse, including cigarette smoking
  • Psychiatric disorder making the subject not a suitable candidate for transplantation
  • History of medical non-compliance
  • Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis)
  • Any history of malignancy except squamous or basal cell skin cancer
  • BMI >28 kg/meter-squared, or body weight >80kg at screening visit, or >85kg on the day of transplantation (due to the difficulty of obtaining a sufficiently large islet mass to adequately treat either large patients or those whose obesity elevates their insulin needs)
  • Positive C-peptide response to intravenous glucose tolerance test and Mixed Meal glucose tolerance test: any C-peptide >0.3 ng/mL post infusion
  • Inability to provide informed consent
  • Age less than 19 or greater than 70 years
  • Creatinine clearance \<60 mL/min/1.73 meter-squared for Group 1 and creatinine clearance \<40 mL/min/1.73 meter-squared for Group 2 (those subjects currently on immunosuppression due to previous kidney transplant)
  • Macroalbuminuria (urinary albumin excretion rate >300 mg/24h) for Group 1 and macroalbuminuria (urinary albumin excretion rate >600mg/24h) for Group 2
  • Baseline Hb \<10 gm/dL
  • Baseline liver function tests outside of normal range
  • Presence of gallstones or hemangioma in liver on baseline ultrasound exam
  • Positive pregnancy test, intention of future pregnancy, or presently breast-feeding
  • Evidence of sensitization on panel reactive antibodies (PRA)
  • Insulin requirement >0.7 IU/kg/day or HbA1c >15%
  • Hyperlipidemia
  • Under treatment for a medical condition requiring chronic use of steroids
  • Use of Coumadin or other anticoagulant therapy (except aspirin) or a prothrombin time/international normalized ratio (PT-INR) >1.5
  • Diagnosis of Addison's disease

Additional Exclusion Criteria for Group 2 Subjects:

  • Any history of organ transplantation other than kidney or pancreas
  • Any previous graft lost to rejection
  • Any history of early, multiple, or vascular renal allograft rejection
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Transplantation of Islets of Langerhans

    Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000 International Units/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.

    Drug: Islets of Langerhans

Interventions

  • DrugIslets of Langerhans

    Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.

    Also known as: transplanted islets of Langerhans

06

What researchers measure

Primary outcomes

  1. Incidence of insulin independence with a single islet transplant

    Incidence of insulin independence with a single transplantation measured at one year post-transplantation.

    Time frame: 1 year post-transplantation

Secondary outcomes

  1. Islet mass resulting in insulin independence/reduced exogenous insulin requirement

    Insulin independence or reduced exogenous insulin required measured at one year post-transplantation.

    Time frame: 1 year post-transplantation

  2. Graft survival

    The survival of the Islets of Langerhans graft as measured at three years post-transplantation.

    Time frame: 3 years post-transplantation

  3. Metabolic functional assessments of the islet graft

    An assessment of the metabolic function of the islet of Langerhans graft as measured three years post-transplantation.

    Time frame: 3 years post-transplantation

07

Study locations

1 site
  • The Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2004 to primary completion in Mar 2011, 84 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2007
First posted
Dec 24, 2007
StartActual
Mar 17, 2004
Primary completionActual
Mar 2011
CompletionActual
Mar 2011
Last update
Dec 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00579371
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Dec 24, 2007
Start date
Mar 17, 2004
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Dec 21, 2023

Study contacts

R Brian Stevens, MD PhD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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