Sernova Cell Pouch for Type 1 Diabetes

Overseen By Piotr Witkowski, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sernova Corp

Must be taking: Insulin

Must not be taking: Systemic steroids, Anticoagulants

Disqualifiers: Obesity, Hypertension, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Sernova Cell Pouch™ for individuals with Type 1 Diabetes who cannot detect dangerously low blood sugar levels and have experienced severe low blood sugar events. The Cell Pouch is implanted in the body, creating a special space for insulin-producing cells to live and function. The goal is to determine if this setup can safely support the long-term survival and function of these cells, potentially improving blood sugar control. Individuals who have had Type 1 Diabetes for at least five years, frequently monitor their blood sugar, and have experienced severe low blood sugar episodes might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative device.

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.

What prior data suggests that the Sernova Cell Pouch is safe for Type 1 Diabetes treatment?

In earlier studies, the Sernova Cell Pouch demonstrated promising safety results for people with Type 1 Diabetes. Research shows that islet cells, which help produce insulin, can survive in the Cell Pouch for one to more than five years, indicating that the treatment is generally well-tolerated over time. The Cell Pouch integrates into the body, forming many tiny blood vessels that enhance the function and longevity of the transplanted cells.

The studies examine the safety of the Cell Pouch for up to five years after the transplant. This long-term focus helps researchers understand the treatment's safety over time. So far, findings suggest that the Cell Pouch is safe and may aid in managing diabetes by supporting insulin-producing cells. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin injections or pumps, the Sernova Cell Pouch™ offers a novel approach by implanting a small device under the skin to house insulin-producing cells. This innovative method aims to restore the body's natural ability to regulate blood sugar, potentially reducing or eliminating the need for regular insulin administration. Researchers are excited because it could significantly improve the quality of life for patients with severe hypoglycemic episodes and hypoglycemia unawareness, providing a more stable and long-term solution compared to current treatments.

What evidence suggests that the Sernova Cell Pouch is effective for Type 1 Diabetes?

Research has shown that the Sernova Cell Pouch, which participants in this trial will receive, holds promise for treating Type 1 Diabetes. This device supports insulin-producing cells, known as islets, in functioning effectively. Studies have found that these islets can survive and function well for over five years. The Cell Pouch creates a natural, blood-rich environment that promotes cell thriving. Specifically, patients in those studies reported an improved quality of life after receiving this treatment. These findings suggest that the Sernova Cell Pouch could be a viable option for managing Type 1 Diabetes, particularly for those experiencing severe low blood sugar episodes. ^{2 3 4 6 7}

Who Is on the Research Team?

Piotr Witkowski, MD PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sernova Cell Pouch™

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.

How Is the Trial Designed?

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

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+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Published Research Related to This Trial

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]

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 Omnipod® 5 Automated Insulin Delivery System demonstrated long-term safety and effectiveness in managing type 1 diabetes, maintaining significant reductions in HbA1c levels over up to 2 years of use among 224 participants.

Participants experienced an increase in time spent within the target glucose range, with minimal severe hypoglycemia incidents, indicating that the system effectively supports glycemic control while being safe for extended use.

NCBI (Pubmed)

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. Criego, AB., Carlson, AL., Brown, SA., et al.[2023]

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 development of automated insulin dosing systems, like the Medtronic MiniMed 670G and 780G, represents significant advancements in managing type 1 diabetes by aiming to 'close the loop' between glucose monitoring and insulin delivery.

DIY artificial pancreas systems, such as OpenAPS, AndroidAPS, and Loop, have emerged from the #WeAreNotWaiting movement, allowing patients and caregivers to create personalized solutions for insulin management, demonstrating real-world benefits in self-management for users across different age groups.

NCBI (Pubmed)

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. Ahmed, SH., Ewins, DL., Bridges, J., et al.[2021]

Citations

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sernova.com

sernova.com/press_releases/sernova-biotherapeutics-provides-positive-interim-data-from-ongoing-phase-1-2-clinical-trial-of-cell-pouch-bio-hybrid-organ-in-patients-living-with-type-1-diabetes/

Sernova Biotherapeutics Provides Positive Interim Data ...

This interim data showing successful functionality of our Cell Pouch Bio-hybrid Organ and improvement in patient reported Quality of Life ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01652911

A Phase I/II Study of the Safety and Efficacy of Sernova's ...

The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet ...

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uchicagomedicine.org

uchicagomedicine.org/find-a-clinical-trial/clinical-trial/irb180166

CLINICAL TRIAL / NCT03513939

This study aims to demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the treatment of T1D in subjects with hypoglycemia ...

4.

sernova.com

sernova.com/wp-content/uploads/2025/03/Q1-2025-MDA_FINAL.pdf

SERNOVA BIOTHERAPEUTICS INC.

Currently, Sernova's Cell Pouch Bio-hybrid Organ is in a Phase 1/2 clinical trial with human donor islets in patients with type 1 diabetes, an ...

5.

sernova.com

sernova.com/press_releases/sernova-announces-new-positive-data-from-phase-i-ii-trial-regarding-islet-survival-and-function/

Sernova Announces New Positive Data from Phase I/II Trial ...

Abundant, richly vascularized and functioning islets observed throughout all chambers of Sernova's Cell Pouch more than 5 years after islet transplantation.

6.

sernova.com

sernova.com/press_releases/sernova-biotherapeutics-provides-update-on-phase-1-2-clinical-trial-of-cell-pouch-bio-hybrid-organ-for-treatment-of-type-1-diabetes/

Sernova Biotherapeutics Provides Update on Phase 1/2 ...

Data from the ongoing trial has demonstrated islet cell survival in T1D patients from one year to more than five years as well as the ability to ...

7.

clinicaltrial.be

clinicaltrial.be/en/details/68749?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

A Safety, Tolerability and Efficacy Study of Sernova's Ce...

The Cell Pouch will be assessed for safety and tolerability for up to five years (recently increased from 3 years) following the last transplant ...