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Islet Cell Transplantation

Islet Cell Transplant for Type 1 Diabetes

Phase 2
Recruiting
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical history compatible with T1D with disease onset < 40 years of age and insulin-dependence for > 5 years at the time of enrollment, and a sum of subject age and insulin dependent diabetes duration of > 28
Male and female subjects age 18 to 68 years.
Must not have
Blood Pressure: SBP > 160 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents
Weight more than 90 kg or body mass index (BMI) > 30 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 ± 14 days after the last islet transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether islet transplantation (a procedure to transplant special cells that produce insulin) is safe when performed after a kidney transplant.

Who is the study for?
This trial is for adults aged 18-68 with Type 1 Diabetes, onset before age 40 and insulin-dependent for over 5 years. Participants must be at least three months post-kidney transplant, on specific immunosuppressants, and not producing their own insulin. They should have stable kidney function without severe allergies or infections, not be pregnant or planning pregnancy soon, and willing to use contraception.
What is being tested?
The study tests the safety of transplanting islet cells from deceased donors into patients who've had a kidney transplant. The goal is to see if these cells can control blood sugar levels in the body without needing insulin injections.
What are the potential side effects?
Potential side effects may include immune reactions against the transplanted cells, low blood sugar events if too much insulin is produced, bleeding or infection from the infusion procedure, and possible drug interactions with current immunosuppressive therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with Type 1 Diabetes before 40, have been on insulin for over 5 years, and my age plus years with diabetes is over 28.
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I am between 18 and 68 years old.
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I am between 18 and 68 years old.
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My body does not produce enough c-peptide when tested.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is high even with medication.
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I weigh over 90 kg or my BMI is over 30.
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My kidney function is low, but not extremely low if I'm a strict vegetarian.
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I have developed proteinuria after my kidney transplant.
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I have an untreated eye condition due to diabetes.
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I do not have, nor have I had, infections like hepatitis B/C, HIV, or TB.
Select...
I use more than 1.0 IU/kg/day or less than 15 U/day of insulin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 ± 14 days after the last islet transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 ± 14 days after the last islet transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HbAlc <6.5% and an absence of severe hypoglycemic events
Secondary study objectives
HbAlc < 6.5% and an absence of severe hypoglycemic events measured after last transplant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Allogenic islet cells (human, U. Chicago)Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intraportal infusion of islet cells
2008
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,049 Total Patients Enrolled

Media Library

Allogenic islet cells (human, U. Chicago) (Islet Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT01241864 — Phase 2
Type 1 Diabetes Research Study Groups: Allogenic islet cells (human, U. Chicago)
Type 1 Diabetes Clinical Trial 2023: Allogenic islet cells (human, U. Chicago) Highlights & Side Effects. Trial Name: NCT01241864 — Phase 2
Allogenic islet cells (human, U. Chicago) (Islet Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01241864 — Phase 2
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT01241864 — Phase 2
~1 spots leftby Dec 2025
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