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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
Must not have
Portal hypertension
Active peptic ulcer disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have high blood pressure in the veins of my liver.
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I have an active stomach ulcer.
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I have severe, ongoing stomach paralysis or diarrhea.
Select...
I currently have an infection.
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My chest X-ray shows signs of cancer or infection.
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I have had an organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: 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
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,052 Previous Clinical Trials
758,989 Total Patients Enrolled
Piotr Witkowski, MD, Ph.D.Principal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 1 diabetes, diagnosed over 5 years ago, am between 18-58 years old, and have undetectable C-peptide levels.I check my blood sugar and inject insulin at least three times a day under a doctor's care.I have diabetes complications like kidney issues, eye problems, or nerve damage.You have unstable blood sugar levels, which can be shown by high and low fluctuations in your blood sugar.I have unstable diabetes, don't feel when my blood sugar is low, or my diabetes is getting worse.I've had a severe low blood sugar episode needing help in the last 2 years.I have high blood pressure in the veins of my liver.I do not have any health issues that would make a transplant or taking immune-suppressing drugs unsafe.I have been diabetic for 5 years or more.I check my blood sugar and inject insulin at least three times a day under a doctor's care.I have had cancer before.I have an active stomach ulcer.I have severe, ongoing stomach paralysis or diarrhea.I currently have an infection.My chest X-ray shows signs of cancer or infection.I have had an organ transplant.I have had a heart attack in the last 6 months.I am between 18 and 58 years old with type 1 diabetes and no detectable C-peptide.
Research Study Groups:
This trial has the following groups:- Group 1: Transplant
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.
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