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Cell Therapy

Islet Cell Transplant for Type 1 Diabetes

Phase 1 & 2

Waitlist Available

Led By Piotr Witkowski, MD, Ph.D.

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have been diabetic for at least five years

Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day), prescribed and supervised by the patient's diabetologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly

Awards & highlights

Study Summary

This trial is testing if it's safe to transplant human islet cells to help control blood sugar in type 1 diabetes patients who have trouble controlling it. Early observations will also be made about if this treatment can help with hypoglycemia.

Who is the study for?

This trial is for people aged 18-58 with type 1 diabetes who have been diabetic for at least five years. They must be on a strict regimen of glucose monitoring and insulin injections, experience severe diabetes complications or hypoglycemic unawareness, and can give informed consent. Excluded are those with recent heart attacks, certain liver issues, obesity (BMI > 28), prior transplants, infections, substance abuse problems, pregnancy or inability to use contraception.Check my eligibility

What is being tested?

The study tests the safety and initial effectiveness of transplanting human islet cells into patients with type 1 diabetes to control blood sugar levels. It follows the 'Edmonton Protocol' which uses specific anti-rejection drugs without steroids during transplantation.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to anti-rejection drugs such as increased infection risk and possible organ inflammation. Specific side effects will depend on individual responses to the transplantation procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diabetic for 5 years or more.

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I check my blood sugar and inject insulin at least three times a day under a doctor's care.

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I am between 18 and 58 years old with type 1 diabetes and no detectable C-peptide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

decrease in incidence of hypoglycemic events

decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent.

Secondary outcome measures

absence of complications from the procedure and side effects of the medication

Trial Design

1Treatment groups

Experimental Treatment

Group I: TransplantExperimental 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,001 Previous Clinical Trials

817,680 Total Patients Enrolled

Piotr Witkowski, MD, Ph.D.Principal InvestigatorUniversity of Chicago

Media Library

Allogenic Islet Cell Transplantation (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00160732 — Phase 1 & 2

Type 1 Diabetes Research Study Groups: Transplant

Type 1 Diabetes Clinical Trial 2023: Allogenic Islet Cell Transplantation Highlights & Side Effects. Trial Name: NCT00160732 — Phase 1 & 2

Allogenic Islet Cell Transplantation (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00160732 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals of advanced age eligible for enrollment in this research?

"By the conditions of this trial, all participants must fall between 18 and 58 years old."

Answered by AI

Do I qualify to be a participant in this medical experiment?

"This clinical trial seeks to onboard 50 qualified candidates with type I diabetes mellitus, aged between 18 and 58 years old. The applicants must have a documented C-peptide of undetectable level and should have had the condition for at least five consecutive years. Additionally, they need to be on an intensive regimen that involves glucose monitoring as well as exogenous insulin injection (at least three injections per day). Furthermore, individuals suffering from brittle diabetes or hypoglycemia unawareness are encouraged to apply; while those experiencing progressive complications such as nephropathy, retinopathy or neuropathy will also be considered eligible. Finally, all"

Answered by AI

Are new participants being invited to join this research endeavor?

"Clinicaltrials.gov suggests that this medical trial is not currently taking on new participants, as it was last edited on November 7th 2022 and initially posted all the way back in October 2003. Despite this, there are still 349 active trials accepting patients today."

Answered by AI