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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 ± 14 days after the last islet transplant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
1,004 Previous Clinical Trials
819,767 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limitation on enrolling in this experiment?

"The lower bound for admission into this medical research is 18 years old, while the upper limit of age eligibility is 68."

Answered by AI

Has the U.S. Food and Drug Administration authorized intraportal infusion of islet cells?

"Data from Phase 2 trials suggests that Intraportal infusion of islet cells has a certain level of safety, giving it an estimated score of two. Unfortunately, there are no clinical studies demonstrating the efficacy of this intervention."

Answered by AI

How many subjects are involved in the current research trial?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment is recruiting participants, having been first published on December 1st 2010 and most recently modified on November 7th 2022. This clinical trial necessitates the signing of 10 patients from a single site."

Answered by AI

Could I become a participant in this research endeavor?

"This clinical trial seeks to enrol 10 people with diabetes or autoimmunity, aged between 18 and 68. The participants must have undergone a renal transplant greater than 3 months ago, be taking the appropriate calcineurin inhibitor-based immunosuppressant (tacrolimus in combination with sirolimus/mycophenolate mofetil/azathioprine; cyclosporine alongside myfortic), prednisone below 10 mg/day as well as islet transplant within 72 hours of kidney implantation from same donor. This study accepts both male and female patients."

Answered by AI

Is this investigation open to new participants?

"Absolutely. According to the data published on clinicaltrials.gov, this research endeavour is currently recruiting participants; it was first announced in December of 2010 and last updated November 7th 2022. The study requires 10 individuals from a single site for enrollment."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Illinois
How old are they?
18 - 65
What site did they apply to?
The University of Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm interested in being a part of research.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Islet Transplantation in Type 1 Diabetic Kidney Allograft
2010. "Islet Transplantation in Type 1 Diabetic Kidney Allograft". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01241864.
All > Paid Studies Illinois > Type 1 Diabetes
~1 spots leftby Dec 2025
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