What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes, such as islet transplantation and immunomodulatory therapies like cePolyTregs, often involve side effects related to immune suppression. These can include an increased risk of infections, potential for organ rejection, and the need for lifelong immunosuppressive medications, which can cause additional side effects such as liver toxicity, gastrointestinal issues, and increased cancer risk. Other common treatments, like insulin therapy, may cause hypoglycemia, weight gain, and injection site reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, primarily focusing on insulin therapy to manage blood glucose levels. However, treatments promoting self-tolerance and suppressing unwanted immune responses, like the cePolyTregs trial, are less common. One notable approach is the use of immunomodulatory therapies, such as teplizumab, which has been studied for its potential to delay the onset of Type 1 Diabetes by modulating the immune system. Additionally, islet transplantation has been explored as a treatment option, though it is limited by the availability of donor organs and the need for lifelong immunosuppression.

What other types of research exist?

Promising novel alternatives to cePolyTregs for Type 1 Diabetes patients include NKTR-358, a polyethylene glycol-interleukin-2 conjugate designed to selectively induce regulatory T cells (Tregs), and otelixizumab, an anti-CD3 monoclonal antibody that modulates immune responses. Both therapies have shown potential in clinical trials for promoting self-tolerance and suppressing unwanted immune responses.

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Cell Therapy

Cell Transplant for Type 1 Diabetes (cePolyTregs Trial)

Phase 1

Waitlist Available

Led By James Shapiro, MD/PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent

Subjects must be 18-68 years old

Must not have

Under treatment for a medical condition requiring chronic use of steroids

Active infection including Hepatitis C, Hepatitis B, HIV, TB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 58 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment using special immune cells called cePolyTregs to help people with type 1 diabetes who are getting islet transplants. These cells help protect the transplanted insulin-producing cells from being attacked by the immune system, improving their function and survival.

Who is the study for?

This trial is for adults aged 18-68 with Type 1 Diabetes (T1DM) who've had it for over 5 years and struggle with blood sugar control despite trying hard. They should have issues sensing low blood sugar or have been hospitalized for related complications within the last year. Participants need to understand the study, agree to its terms, and not be on certain medications like anticoagulants or planning pregnancy.

What is being tested?

The trial tests cePolytreg cells in people receiving Islet transplants to manage T1DM. These special cells might help patients accept their new insulin-producing cells without needing lifelong anti-rejection drugs by preventing unwanted immune responses that could damage the transplant.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased risk of infection, possible infusion-related reactions from the cePolytreg treatment, and any unforeseen impacts on organ function.

Eligibility Criteria

Inclusion Criteria

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

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I understand the study's risks and have signed the consent form.

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I am between 18 and 68 years old.

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My blood sugar levels are unstable and have led to hospital visits.

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I have had Type 1 Diabetes for over 5 years.

Exclusion Criteria

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

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I am on long-term steroids for another health issue.

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

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My cholesterol levels are very high and not under control.

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I need more than 1 unit of insulin per kilogram of my body weight daily.

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I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.

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I do not have severe heart problems, recent heart attacks, or very poor heart function.

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I am suspected to have rapidly worsening kidney problems.

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I have Celiac disease that has not been treated.

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

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

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I was diagnosed with Type 1 diabetes after age 40 and have been on insulin for less than 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 58 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~58 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 58 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events

Secondary study objectives

Stimulated C-peptide level

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Participants will receive cePolyTregs (target 400-1600 million, with a minimal acceptable dose of 100 million) two weeks post islet transplant and will be followed for 1 year after cePolyTregs infusion to assess the safety and preliminary efficacy of cePolyTregs therapy.

Group II: ControlActive Control1 Intervention

The Participants in this arm receive islet transplant only and no cePolyTregs.

0 / 15Eligibility 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

Common treatments for Type 1 Diabetes (T1D) include insulin therapy, which replaces the insulin that the body can no longer produce, and immunomodulatory therapies that aim to prevent the immune system from attacking pancreatic beta cells. The cePolyTregs trial focuses on using regulatory T cells (Tregs) to promote self-tolerance and suppress unwanted immune responses, potentially preserving beta-cell function and reducing the need for exogenous insulin. These treatments are essential for managing blood glucose levels and preventing complications in T1D patients.

Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial.Type 1 diabetes mellitus and its oral tolerance therapy.Progress in the development of immune-based therapies for type 1 diabetes mellitus.