What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, islet cell transplantation, and emerging therapies like the Cell Pouch™. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. Islet cell transplantation, similar to the Cell Pouch™, may lead to side effects such as infection, bleeding, and the need for immunosuppressive drugs, which can increase the risk of infections and other complications. The Cell Pouch™ aims to provide a more natural environment for islet cells, potentially reducing some risks, but long-term data on its specific side effects are still being studied.

What prior FDA approvals exist?

The Cell Pouch™ is an innovative approach involving an implantable device designed for islet transplantation to treat Type 1 Diabetes. While specific FDA approvals for similar scaffold-based islet transplantation devices are not detailed, the FDA has approved other cell-based therapies for Type 1 Diabetes. For instance, the use of human embryonic stem cell-derived beta cells has shown promise in preclinical studies for glycemic control. Additionally, traditional islet transplantation has been explored, though it faces challenges such as immune rejection and the need for immunosuppressive therapy.

What other types of research exist?

Promising novel alternatives to the Cell Pouch™ for Type 1 Diabetes patients include stem cell-derived β-cells and encapsulation technologies. These approaches aim to restore endogenous insulin production and maintain normoglycemia. Recent advances in these fields are moving towards clinical development and may offer effective treatment options in 2024.

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Procedure

Sernova Cell Pouch for Type 1 Diabetes

Phase 1 & 2

Recruiting

Led By Piotr Witkowski, MD, PhD

Research Sponsored by Sernova Corp

Eligibility Criteria Checklist

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

Must have

Clinical history compatible with Type 1 Diabetes Mellitus (T1DM) with onset of disease at <40 years of age, insulin-dependence for ≥5 years at the time of consent, and a sum of patient age and insulin dependent diabetes duration of ≥28

Male and female patients 18 to 65 years of age

Must not have

Untreated proliferative diabetic retinopathy

Presence of colostomy/ileostomy, incisional hernia or other deformity of the abdominal wall precluding implantation of the Cell Pouch

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 0 to 90±5 ; day 90±5 to day 180±5; day 180±5 to day 365±14 following final cell pouch transplant and/or last transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of the Cell Pouch, an implantable device for people with Type 1 Diabetes who struggle with severe low blood sugar. The device holds insulin-producing cells in a natural, blood-rich environment to help them survive and function well. The study will monitor patients over several years to ensure the treatment is safe and works as intended.

Who is the study for?

Adults aged 18-65 with Type 1 Diabetes Mellitus, hypoglycemia unawareness, and severe hypoglycemic episodes can join. They must be under intensive diabetes management and have no stimulated c-peptide response. Exclusions include kidney issues, substance abuse, severe heart disease, uncontrolled lipid levels, certain infections or cancers, immunosuppressive treatments, high HbA1c levels or blood pressure, previous transplants (pancreas/islet), allergies to polymers and those not using contraception.

What is being tested?

The trial is testing the Cell Pouch™ implanted with insulin-producing cells for treating Type 1 Diabetes in patients who don't sense low blood sugar well. The device aims to create a natural environment for cell transplant and function within the body by forming tissue chambers that support engraftment of these cells.

What are the potential side effects?

Potential side effects may include reactions at the implant site such as pain or infection; immune responses against the implanted cells; low blood sugar if insulin production exceeds need; potential complications from surgery like bleeding or clotting.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with Type 1 Diabetes before 40, have been on insulin for 5+ years, and my age plus years with diabetes is 28 or more.

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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 have diabetic eye disease that hasn't been treated.

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I do not have a colostomy/ileostomy, hernia, or other abdominal wall issues that would prevent implant surgery.

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I have no cancer history, except for treated skin cancer.

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I have high blood pressure in the veins of my liver.

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I am not on any immunosuppressive treatments currently.

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My kidney function is reduced.

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I do not have severe heart issues or uncontrolled blood and liver conditions.

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I do not have severe ongoing stomach issues that affect my medication absorption.

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My donor for islet cells did not have a heart attack and is not high-risk.

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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 have a history of severe high blood pressure or conditions that prevent me from having general anesthesia.

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I do not have, nor have I had, infections like hepatitis B/C, HIV, or TB.

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I have not received treatment for Graves' disease.

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I have had an islet transplant before.

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I need more than 1.0 IU/kg/day of insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 0 to 90±5 ; day 90±5 to day 180±5; day 180±5 to day 365±14 following final cell pouch transplant and/or last transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 0 to 90±5 ; day 90±5 to day 180±5; day 180±5 to day 365±14 following final cell pouch transplant and/or last transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to 90±5 ; day 90±5 to day 180±5; day 180±5 to day 365±14 following final cell pouch transplant and/or last 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 assess the safety of the Cell Pouch following implantation, and islet transplantation, by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch

Secondary study objectives

Proportion of participants with a reduction in HbA1c >1mg%

Hypoglycemia

Survival of endocrine tissue in the Cell Pouch (defined by positive staining of islets during histological analysis)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: T1D Cell Pouch RecipientsExperimental Treatment1 Intervention

Eligible Type 1 Diabetes Mellitus (T1D) subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes undergoing Sernova Cell Pouch intervention

0 / 17Eligibility 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 primary treatments for Type 1 Diabetes include insulin therapy, islet cell transplantation, and investigational approaches like the Cell Pouch™. Insulin therapy involves administering exogenous insulin to manage blood glucose levels, compensating for the body's inability to produce insulin. Islet cell transplantation involves transplanting functional islet cells into the patient to restore insulin production. The Cell Pouch™ is a novel scaffold implanted into the body to create a natural, vascularized environment for transplanted islet cells, promoting their engraftment and long-term function. These treatments are crucial for T1D patients as they aim to restore normal insulin production and regulation, reducing the risk of severe hypoglycemic episodes and improving overall glucose control.