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.
- Type 1 Diabetes
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
2 Treatment Groups
T1DM Cell Pouch™ Recipients
1 of 2
T1D Cell Pouch Recipients
1 of 2
13 Total Participants · 2 Treatment Groups
Primary Treatment: Sernova Cell Pouch™ · No Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 18 - 65 · All Participants · 8 Total Inclusion CriteriaMark “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
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
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
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
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