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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
Must not have
Insulin requirement of > 1.0 IU/kg/day
Calculated glomerular filtration rate (GFR) < 80mL/min for transplant-naïve patients or 50mL/min for previously transplanted patients currently on immunosuppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years after the final islet transplant.
Awards & highlights

Summary

This trial tests a treatment for type 1 diabetes involving the transplant of insulin-producing cells and a drug that helps the body accept these cells by calming the immune system. It targets patients who have dangerous low blood sugar levels that they can't detect. The new cells help control blood sugar.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use more than 1 unit of insulin per kilogram of my body weight daily.
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My kidney function, measured by GFR, is below the required level for my transplant history.
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I do not have active infections like hepatitis B, C, HIV, or TB.
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I have a serious heart artery condition.
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I have painful gallstones.
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I have stomach or intestine problems that affect how I absorb pills.
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I regularly use corticosteroids.
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I have had cancer before, but it was not skin cancer that was removed.
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My blood takes longer to clot and I am on long-term blood thinners.
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I am not pregnant, breastfeeding, and I am willing to use contraception during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years after the final islet transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years after the final islet transplant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 • NCT00566813
100%
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Type 1 Diabetes (T1D) include insulin therapy, islet transplantation, and immunosuppressive medications. Insulin therapy involves administering insulin to manage blood glucose levels, as T1D patients cannot produce insulin due to autoimmune destruction of pancreatic beta cells. Islet transplantation aims to restore insulin production by transplanting functional islet cells into the patient. Immunosuppressive medications, such as Campath (alemtuzumab), are used to prevent the immune system from rejecting the transplanted islet cells by depleting lymphocytes. These treatments are crucial for T1D patients as they address both the need for insulin and the underlying autoimmune response, potentially improving blood sugar control and reducing the risk of severe hypoglycemic episodes.
Islet transplantation modulates macrophage to induce immune tolerance and angiogenesis of islet tissue in type I diabetes mice model.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,629 Previous Clinical Trials
958,150 Total Patients Enrolled
Daniel Borja-Cacho, MDPrincipal InvestigatorNorthwestern University

Media Library

Islet Cell Transplant (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01897688 — Phase 3
Type 1 Diabetes Research Study Groups: Islet Cell Transplant
Type 1 Diabetes Clinical Trial 2023: Islet Cell Transplant Highlights & Side Effects. Trial Name: NCT01897688 — Phase 3
Islet Cell Transplant (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01897688 — Phase 3
~1 spots leftby Mar 2025