What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, islet transplantation, and immunosuppressive medications. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. Islet transplantation, which aims to restore insulin production, may lead to complications such as bleeding, infection, and the need for lifelong immunosuppression. Campath (alemtuzumab), used to prevent immune rejection in islet transplantation, can cause side effects like infusion reactions, increased risk of infections, and lymphopenia (a decrease in lymphocytes). Patients should discuss these potential risks with their healthcare provider to make informed decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, primarily focusing on insulin therapy and immunomodulatory drugs. While islet transplantation is a promising approach, it is still under clinical investigation and not yet widely approved. Campath (alemtuzumab), an immunosuppressive drug that depletes lymphocytes to prevent immune rejection, is being studied in combination with islet transplantation to restore insulin production. Other immunomodulatory therapies, such as abatacept and teplizumab, have shown potential in clinical trials by delaying the progression of Type 1 Diabetes and preserving beta-cell function, but they are not yet standard treatments.

What other types of research exist?

Promising novel alternatives to Islet Transplantation with Campath for Type 1 Diabetes patients include: 1) Co-stimulatory blockade therapies such as CTLA4-Ig (abatacept), which modulate T cell activation and have shown potential in preserving beta-cell function. 2) Tolerogenic immunosuppression strategies that aim to induce immune tolerance without lifelong immunosuppression. 3) Advanced cell-based therapies, including stem cell-derived beta cells, which are being developed to replace destroyed beta cells and restore insulin production. These alternatives are in various stages of research and clinical trials, showing potential for future treatment options.

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Cell Therapy

Islet Cell Transplant for Type 1 Diabetes

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

Pivotal Trial

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 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.

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%

Study treatment Arm

Islet Cells

Islet Cells + Etanercept + Exenatide

Awards & Highlights

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.

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

0 / 13Eligibility criteria met

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.