What side effects are associated with this type of intervention?

Allogeneic islet transplantation, a treatment aimed at restoring insulin production in Type 1 Diabetes patients, can have several side effects. These include risks associated with the transplant procedure itself, such as bleeding and infection. Additionally, patients must take immunosuppressive drugs to prevent rejection of the transplanted cells, which can lead to increased susceptibility to infections, kidney damage, and other complications. Common treatments like insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. Overall, while these treatments can significantly improve glycemic control, they come with a range of potential side effects that need to be carefully managed.

What prior FDA approvals exist?

The FDA has approved several advanced therapies for Type 1 Diabetes, including islet cell transplantation. This procedure involves transplanting donor islet cells to restore insulin production and improve glycemic control. Clinical trials, such as those conducted at the University of Illinois at Chicago (UIC), have demonstrated the safety and efficacy of allogeneic islet transplantation. These trials have shown promising results in improving glycemic control in Type 1 diabetic patients, positioning islet cell transplantation as a potential mainstay treatment for managing the disease.

What other types of research exist?

Promising novel alternatives to allogeneic islet transplantation for Type 1 Diabetes patients include: 1) Stem cell-derived beta cells: Human pluripotent stem cells can be differentiated into insulin-producing beta cells, which have shown potential in reversing diabetes in preclinical models. 2) Encapsulated beta cells: Encapsulation technology protects transplanted beta cells from immune attack, potentially eliminating the need for immunosuppression. 3) Immunomodulatory therapies: These therapies aim to modify the immune response to prevent the autoimmune destruction of beta cells, potentially preserving or restoring endogenous insulin production.

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Cell Therapy

Islet Transplantation for Type 1 Diabetes

Phase 3

Waitlist Available

Led By Jose Oberholzer, MD

Research Sponsored by CellTrans Inc.

Eligibility Criteria Checklist

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

Must have

Type 1 diabetes mellitus for more than 5 years complicated by reduced awareness of hypoglycemia

Type 1 diabetes mellitus for more than 5 years complicated by at least one episode of severe hypoglycemia in the past 3 years

Must not have

Family history of MEN2 or MCT

Stroke within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after islet transplant

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

Summary

This study is evaluating whether islet transplantation is safe and effective for people with type 1 diabetes.

Who is the study for?

This trial is for Type 1 diabetes patients who've had the disease for over 5 years and experienced severe hypoglycemia or have reduced hypoglycemia awareness. Exclusions include those with pancreatitis, kidney issues, substance abuse, certain infections like hepatitis or HIV, pregnancy/breastfeeding without contraception use, some heart conditions, and other specific health concerns.

What is being tested?

The trial tests the safety and effectiveness of transplanting islet cells to control blood sugar in Type 1 diabetes using the UIC protocol. This follows a successful earlier phase where this method showed promise without using steroids for immunosuppression.

What are the potential side effects?

Potential side effects may include reactions to immunosuppressants such as increased infection risk, possible organ inflammation due to immune response, digestive issues from medication absorption problems, and complications related to underlying health conditions.

Eligibility Criteria

Inclusion Criteria

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

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I have had Type 1 diabetes for over 5 years and often don't notice when my blood sugar is low.

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I have had Type 1 diabetes for over 5 years and experienced a severe low blood sugar episode in the last 3 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My family has a history of MEN2 or MCT.

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I have not had a stroke in the last 6 months.

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I have Addison's disease.

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I need to take steroids regularly for a health condition.

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I have painful gallstones.

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I have symptoms of an active stomach ulcer.

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I have had cancer before, but not skin cancer.

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I am either younger than 18 or older than 75.

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I have an untreated eye condition where blood vessels grow abnormally.

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I have severe ongoing stomach issues that could affect how I absorb medication.

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I have or am being treated for tuberculosis.

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My mental health condition is stable on medication.

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My hemoglobin level is below the normal range for my gender.

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I do not have active infections like hepatitis C, B, or HIV.

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I have not had any live vaccines in the last 2 months.

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I am taking blood thinners or have a PT-INR greater than 1.5.

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I use more than 0.7 units of insulin per kilogram of my body weight daily.

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I have had a heart attack in the last 6 months or have heart disease that can't be fixed with surgery.

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My kidney function, measured by creatinine clearance, is below normal.

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I have pancreatitis.

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I have Factor V deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after islet infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after islet infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after islet infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Subjects Reaching the Efficacy Goal

Treatment Emergent Adverse Events

Secondary study objectives

Hypoglycemic Episodes by HYPO Score

Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant

Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: TreatmentExperimental Treatment1 Intervention

All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans.

0 / 23Eligibility 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

Type 1 Diabetes (T1D) treatments primarily focus on replacing the insulin that the body can no longer produce. Insulin therapy, through injections or pumps, aims to regulate blood glucose levels by mimicking natural insulin release. Allogeneic islet transplantation, an advanced treatment, involves transplanting donor islet cells to restore the body's ability to produce insulin. This can significantly improve glycemic control and reduce dependence on external insulin sources, offering a potential improvement in the quality of life for T1D patients.