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Islet Cell Transplantation

Islet Cell Transplant for Type 1 Diabetes

N/A
Recruiting
Led By Piotr Witkowski, MD, PhD
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 onset of disease at < 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a sum of patient age and insulin dependent diabetes duration of ≥ 28 and absent stimulated c-peptide (<0.3ng/mL) in response to a mixed meal tolerance test (MMTT; Boost® 6 mL/kg body weight to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for Boost) measured at 60 and 90 min after the start of consumption and at least one episode of severe hypoglycemia in the 12 months prior to study enrollment; OR a clinical history of "problematic hypoglycemia" defined as defined as two or more episodes per year of severe hypoglycemia or as one episode associated with impaired awareness of hypoglycemia, extreme glycemic lability, or major fear and maladaptive behavior according to recent clinical recommendations.
Male and female patients 18 to 70 years of age
Must not have
Presence or history of panel-reactive anti-HLA antibodies above 30% or history/presence of donor specific anti-HLA antibodies
Body mass index (BMI) >30 kg/m2 or patient weight <50kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether islet transplantation is safe for people with Type 1 diabetes. Islets are clusters of cells that produce insulin, and the trial will use islets from cadaver donors.

Who is the study for?
This trial is for adults aged 18-70 with Type 1 Diabetes (T1D) diagnosed before age 40, insulin-dependent for at least 5 years, and have a history of severe or problematic hypoglycemia despite intensive diabetes management. Participants must not be overweight, pregnant, or planning pregnancy soon. They should also not have certain blood or immune conditions.
What is being tested?
The study tests the safety of transplanting islet cells from donors into patients' livers to manage blood sugar levels in T1D without daily insulin shots. The goal is to achieve better control over blood glucose with these transplanted cells that produce insulin.
What are the potential side effects?
Potential side effects may include reactions to the infusion like pain or discomfort, low blood sugar if the body reacts strongly to new insulin-producing cells, and risks associated with immunosuppressive drugs needed to prevent rejection of the transplanted cells.

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, need insulin for over 5 years, and have had severe low blood sugar.
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I am between 18 and 70 years old.
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I am between 18 and 70 years old.
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I check my glucose at least 3 times daily and use insulin injections or a pump as directed by my specialist.
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I was diagnosed with Type 1 Diabetes before 40, have been on insulin for 5+ years, and my age plus diabetes duration is 28 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have high levels of certain antibodies against transplant tissues.
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My BMI is over 30 or I weigh less than 50kg.
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I use more than 1.0 IU/kg/day or less than 15 units/day of insulin.
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I have a serious heart condition.
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I have a condition that causes my blood to clot more than normal.
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I have pancreatitis.
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I have painful gallstones.
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I do not have, nor have I had, hepatitis B, C, HIV, or TB.
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I have diabetic eye disease that hasn't been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 <7.0% and an absence of severe hypoglycemic events

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
1,056 Previous Clinical Trials
760,889 Total Patients Enrolled
Piotr Witkowski, MD, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Allogenic islet cells (human, U. Chicago) (Islet Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT01630850 — N/A
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: NCT01630850 — N/A
Allogenic islet cells (human, U. Chicago) (Islet Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01630850 — N/A
~1 spots leftby May 2025
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