Sernova Cell Pouch for Type 1 Diabetes

Overseen by Piotr Witkowski, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Sernova Corp

Must be taking: Insulin

Must not be taking: Systemic steroids, Anticoagulants

Disqualifiers: Obesity, Hypertension, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anti-diabetic medication other than insulin within 4 weeks of the transplant. If you are on systemic steroids, you may need to adjust your dosage unless it's 5 mg or less of prednisone daily or an equivalent dose of hydrocortisone for replacement purposes.

How is the Sernova Cell Pouch treatment different from other treatments for type 1 diabetes?

The Sernova Cell Pouch treatment is unique because it involves implanting a small device under the skin that houses insulin-producing cells, potentially reducing the need for frequent insulin injections and continuous glucose monitoring, unlike traditional insulin therapies. ^{1 2 3 4 5}

Research Team

Piotr Witkowski, MD PhD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

You are not aware when your blood sugar gets too low.

I am mentally stable and can follow the study's procedures.

I manage my diabetes intensively with multiple daily checks and insulin doses, under a specialist's care.

Exclusion Criteria

I have diabetic eye disease that hasn't been treated.

I am not pregnant, not breastfeeding, and willing to use contraception during and 4 months after the study.

Known allergy or hypersensitivity to polymers More information on this criterion is in the protocol

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Stabilization

Cell Pouch is implanted and immunosuppression is initiated and optimized for vascularization and stabilization prior to islet transplantation

6 weeks

Islet Transplantation

Highly purified islets are transplanted into the Cell Pouch

1 week

Follow-up

Participants are monitored for safety and effectiveness after islet transplantation

365 days

Long-term Follow-up

Assessment of safety and tolerability of islet transplantation into the Cell Pouch for up to five years

5 years

Treatment Details

Interventions

• Sernova Cell Pouch™ (Procedure)

Trial Overview 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.

Participant Groups

Group I: T1D Cell Pouch Recipients Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sernova Corp

Lead Sponsor

Trials

2

Recruited

20+

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+

Breakthrough T1D

Collaborator

Trials

3

Recruited

190+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Dr. Aaron J. Kowalski

Juvenile Diabetes Research Foundation

Chief Executive Officer since 2019

PhD in Microbiology and Molecular Genetics from Rutgers University

Dr. Thomas Danne

Juvenile Diabetes Research Foundation

Chief Medical Officer

MD from Albert Einstein College of Medicine

Findings from Research

A study comparing severe hypoglycaemia in type 1 diabetes patients from 1984 to 1998 found a more than 50% increase in prevalence, despite better management practices like multiple insulin injections and daily blood glucose monitoring.

The research identified that factors like unawareness of hypoglycaemia and HbA1c levels contributed to this increased risk, suggesting that new insulin therapies and improved glucose monitoring systems are needed to better protect patients from severe hypoglycaemic episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Episodes of severe hypoglycemia--increasing problem in type 1 diabetes]. Bragd, J., Oskarsson, P., Adamson, U., et al.[2022]

The Medtronic 670G device has been shown to significantly reduce the burden of managing Type 1 diabetes by improving insulin dosing safety and effectiveness.

Advancements in insulin products and glucose monitoring technologies, including the Medtronic 670G, have contributed to fewer long-term complications and instances of hypoglycemia for individuals with Type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of a commercially available hybrid closed-loop insulin-delivery system in the treatment of Type 1 diabetes. Stone, JY., Haviland, N., Bailey, TS.[2019]

The MiniMed™ 670G system with SmartGuard™ technology was safely used at home by 105 children with type 1 diabetes for 3 months, showing no severe hypoglycemia or diabetic ketoacidosis incidents.

Participants experienced significant improvements in glucose control, with a decrease in HbA1c from 7.9% to 7.5% and an increase in time spent within the target glucose range from 56.2% to 65.0%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Forlenza, GP., Pinhas-Hamiel, O., Liljenquist, DR., et al.[2022]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

[Episodes of severe hypoglycemia--increasing problem in type 1 diabetes]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Review of a commercially available hybrid closed-loop insulin-delivery system in the treatment of Type 1 diabetes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Do-It-Yourself (DIY) Artificial Pancreas Systems for Type 1 Diabetes: Perspectives of Two Adult Users, Parent of a User and Healthcare Professionals. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. [2023]