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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 ± 14 days after the last islet transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 ± 14 days after the last islet transplant
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
759,064 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is high even with medication.I do not have certain harmful antibodies against a transplant.I am not pregnant, breastfeeding, or planning to become pregnant and will use effective birth control.I am over 3 months post-kidney transplant and on specific immune-suppressing drugs, or I will receive a kidney and islet transplant from the same donor within 72 hours.I have had an organ transplant, but not of the kidney, except a failed early pancreatic graft.I weigh over 90 kg or my BMI is over 30.My kidney function is low, but not extremely low if I'm a strict vegetarian.My kidney function has been stable for the last 3 months.I have developed proteinuria after my kidney transplant.I have an untreated eye condition due to diabetes.I do not have, nor have I had, infections like hepatitis B/C, HIV, or TB.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.I am between 18 and 68 years old.I use more than 1.0 IU/kg/day or less than 15 U/day of insulin.I am between 18 and 68 years old.My body does not produce enough c-peptide when tested.
Research Study Groups:
This trial has the following groups:- Group 1: Allogenic islet cells (human, U. Chicago)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT01241864 — Phase 2
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