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Cell Therapy
Islet Cell Transplant for Type 1 Diabetes
Phase 3
Waitlist Available
Led By Daniel Borja-Cacho, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absent stimulated c-peptide (<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years after the final islet transplant.
Awards & highlights
Study Summary
This trial is testing a possible treatment for type 1 diabetes that involves transplanting insulin-producing cells and suppressing the immune system to prevent rejection.
Who is the study for?
This trial is for adults aged 18-65 with Type 1 Diabetes, specifically those who've had severe hypoglycemia and aren't aware when their blood sugar gets too low. They should have been insulin-dependent for at least 5 years, mentally stable, and under a doctor's care for diabetes management for over a year. People with obesity, high insulin needs, certain infections or diseases, pregnancy or breastfeeding women, and those not using contraception are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of transplanting islet cells into patients with Type 1 Diabetes who often have dangerously low blood sugar without realizing it. It includes immunosuppressive drugs to prevent rejection of the transplanted cells.See study design
What are the potential side effects?
Possible side effects include reactions to immunosuppressive medications like Campath such as increased infection risk due to weakened immunity, liver function issues from medication toxicity, digestive problems affecting medication absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body does not produce enough insulin after a meal test.
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I have been under a doctor's care for diabetes for at least a year.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years after the final islet transplant.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years after the final islet transplant.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
Secondary outcome measures
To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics
To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics.
Side effects data
From 2020 Phase 1 & 2 trial • 10 Patients • NCT00566813100%
Transient anemia
25%
Increased creatinine
25%
Irregular menstrual bleeding and ruptured ovarian cyst
100%
80%
60%
40%
20%
0%
Study treatment Arm
Islet Cells
Islet Cells + Etanercept + Exenatide
Trial Design
1Treatment groups
Experimental Treatment
Group I: Islet Cell TransplantExperimental Treatment1 Intervention
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islet Cell Transplant
2004
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,191 Total Patients Enrolled
Daniel Borja-Cacho, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have painful gallstones.I have stomach or intestine problems that affect how I absorb pills.You have high levels of protein in your urine.I use more than 1 unit of insulin per kilogram of my body weight daily.Your baseline hemoglobin level is below the normal range.You have had type 1 diabetes and required insulin for at least 5 years, and meet specific medical criteria including low c-peptide levels, severe hypoglycemia, reduced awareness of hypoglycemia, or previous islet cell transplant with continued need for insulin and immunosuppression medication.You had a very low blood sugar episode at least once in the past year.My kidney function, measured by GFR, is below the required level for my transplant history.You have tested negative for the Epstein-Barr Virus (EBV) using a specific blood test.Your liver function tests show that your liver is not working properly.Your cholesterol levels are too high and not well controlled.My blood takes longer to clot and I am on long-term blood thinners.My body does not produce enough insulin after a meal test.I have a serious heart artery condition.I regularly use corticosteroids.I have been under a doctor's care for diabetes for at least a year.I do not have active infections like hepatitis B, C, HIV, or TB.I am between 18 and 65 years old.I am mentally stable and can follow the study's procedures.I have had cancer before, but it was not skin cancer that was removed.Your body mass index (BMI) is higher than 30.You have problems with drinking alcohol or using drugs.I am not pregnant, breastfeeding, and I am willing to use contraception during the study.Your HbA1c level is higher than 10%.You have a high level of specific antibodies in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Islet Cell Transplant
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include middle-aged participants?
"As this trial's eligibility requirements state, the minimum age for enrollment is 18 and the maximum age is 65."
Answered by AI
Could I possibly partake in this experiment?
"To take part in this experiment, patients must be unconscious and aged 18-65. Right now, the team is looking for around 40 individuals to help with the study."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
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