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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbAlc <7.0% and an absence of severe hypoglycemic events

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
819,757 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

Frequently Asked Questions

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

Are the criteria for this medical trial compatible with my health profile?

"The clinical trial is presently recruiting 20 participants aged 18-70 who suffer from diabetes and other autoimmune diseases. In order to be eligible, male or female patients must provide written informed consent and demonstrate an age plus duration of insulin dependent diabetes duration of 28 or more; have experienced at least one episode of severe hypoglycemia within the past year; partake in intensive glucose management under a medical professional's direction with 3+ evaluations yearly; display reduced awareness/fear of hypoglycemia as proven by Clarke score >4 or HYPO Score >90th percentile (1047) during screening period & last 6 months OR LI score >90"

Answered by AI

How many participants is this study accepting for its research?

"Yes, the clinicaltrials.gov website has updated information about this current trial that began on May 1st 2012 and was last revised December 22nd 2020. The research is looking to recruit 20 people from a single location."

Answered by AI

Is this clinical trial open to individuals younger than 85 years?

"For inclusion in this study, participants must be 18 years of age or older and no more than 70 years old."

Answered by AI

Are there remaining vacancies in this research project?

"Affirmative. Data hosted on clinicaltrials.gov validates that this medical study, which was originally posted on May 1st 2012, is actively recruiting for candidates. 20 participants need to be enrolled from a single place of care."

Answered by AI

Who else is applying?

What state do they live in?
New York
Arkansas
Washington
How old are they?
18 - 65
What site did they apply to?
University of Chicago Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Islet Transplantation in Patients With "Brittle" Type I Diabetes
2012. "Islet Transplantation in Patients With "Brittle" Type I Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01630850.
All > Paid Studies Illinois > Type 1 Diabetes
~2 spots leftby May 2025
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