Sernova Cell Pouch™ for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago Medical Center, Chicago, ILType 1 DiabetesSernova Cell Pouch™ - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new device for people with Type 1 Diabetes Mellitus who have hypoglycemia unawareness and a history of severe hypoglycemic episodes. The device is implanted in the abdominal wall and is designed to form a natural environment for therapeutic cells to be transplanted into. The goal of the trial is to demonstrate the safety and tolerability of islet transplantation into the device.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 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

365 days ±14 days
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
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™
Day 5
Survival of endocrine tissue in the Cell Pouch (defined by positive staining of islets during histological analysis)
Day 5
Survival of endocrine tissue in the Cell Pouch™ (defined by positive staining of islets during histological analysis)
Day 365
Proportion of participants with a reduction in HbA1c >1mg%
Hypoglycemia

Trial Safety

Trial Design

2 Treatment Groups

T1DM Cell Pouch™ Recipients
1 of 2
T1D Cell Pouch Recipients
1 of 2

Experimental Treatment

13 Total Participants · 2 Treatment Groups

Primary Treatment: Sernova Cell Pouch™ · No Placebo Group · Phase 1 & 2

T1DM Cell Pouch™ Recipients
CombinationProduct
Experimental Group · 1 Intervention: Sernova Cell Pouch™ · Intervention Types: CombinationProduct
T1D Cell Pouch Recipients
CombinationProduct
Experimental Group · 1 Intervention: Sernova Cell Pouch · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

CTI Clinical Trial and Consulting ServicesOTHER
33 Previous Clinical Trials
3,551 Total Patients Enrolled
ICON plcIndustry Sponsor
69 Previous Clinical Trials
19,540 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
213 Previous Clinical Trials
106,273 Total Patients Enrolled
University of ChicagoOTHER
935 Previous Clinical Trials
754,121 Total Patients Enrolled
Sernova CorpLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
Piotr Witkowski, MD, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

How many individuals will be given lenalidomide in this experiment?

"That is correct. Currently, the clinical trial displayed on clinicaltrials.gov is looking for 13 patients from 1 location. The study was created on 2/7/2019 and was last edited on 11/11//2022." - Anonymous Online Contributor

Unverified Answer

Are participants currently being enrolled in this research?

"According to the latest information from clinicaltrials.gov, this study is still looking for volunteers. The trial was first posted on February 7th, 2019 and was last updated on November 11th, 2020." - Anonymous Online Contributor

Unverified Answer

Are people aged 50 and up being recruited for this trial?

"The ages of patients that can be enrolled in this clinical trial range from 18 to 65 years old." - Anonymous Online Contributor

Unverified Answer

Could I be a potential candidate for this research project?

"This clinical trial is looking for 13 individuals that have diabetes mellitus and meet the following age requirement: between 18-65 years old. Most importantly, candidates must also be able to comply with the procedures of the study protocol, have a compatible clinical history with Type 1 Diabetes Mellitus, insulin dependent for at least 5 years, and both the patient's age and insulin dependent diabetes duration must add up to 28 or more. In addition, patients must be intensively managing their diabetes under the direction of an endocrinologist, diabetologist, or diabetes specialist—this includes having three or more clinical evaluations in the 12 months leading up to consent" - Anonymous Online Contributor

Unverified Answer

What are the main goals that researchers hope to achieve with this trial?

"The sponsor of the study, Sernova Corp, reports that the primary objective is to measure safety by evaluating adverse events over a 365 day period ±14 days. This will be done by looking at the incidence and severity of probable or highly probable adverse events related to the Cell Pouch™. Additionally, this trial will look at secondary outcomes including hypoglycemic event reduction and HbA1c levels post-transplant. Finally, this study will also observe if there is survival of endocrine tissue in the Cell Pouch™ following transplantation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.