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Sernova Cell Pouch for Type 1 Diabetes
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.You are not aware when your blood sugar gets too low.I do not have a colostomy/ileostomy, hernia, or other abdominal wall issues that would prevent implant surgery.I tested negative for Epstein Barr Virus.I haven't had a serious fungal infection in the last year.I have no cancer history, except for treated skin cancer.I have high blood pressure in the veins of my liver.I have not received any live vaccines in the last 2 months.I am not on any immunosuppressive treatments currently.Your body mass index (BMI) is over 30, which means you are considered obese.Your blood pressure is too high, with a systolic blood pressure over 160 or a diastolic blood pressure over 100.You are currently using alcohol or drugs in a way that's harmful.Your hemoglobin level is lower than the normal range when first joining the study.My kidney function is reduced.I do not have severe heart issues or uncontrolled blood and liver conditions.I do not have severe ongoing stomach issues that affect my medication absorption.I am mentally stable and can follow the study's procedures.I haven't taken any diabetes medication except insulin in the last 4 weeks.My donor for islet cells did not have a heart attack and is not high-risk.I manage my diabetes intensively with multiple daily checks and insulin doses, under a specialist's care.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.I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.I have a history of severe high blood pressure or conditions that prevent me from having general anesthesia.Your body does not produce enough c-peptide when tested after eating a meal.I do not have, nor have I had, infections like hepatitis B/C, HIV, or TB.You had a serious drop in blood sugar in the past year.I am between 18 and 65 years old.I have not received treatment for Graves' disease.I am on long-term steroids, but only a low dose for replacement needs.Your glycated hemoglobin (HbA1c) level is higher than 13%.You have a high level of antibodies that can react with donated organs.I have had a pancreas transplant.I have had an islet transplant before.You have a history of having a lot of protein in your urine.I need more than 1.0 IU/kg/day of insulin.
- Group 1: T1D Cell Pouch Recipients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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"
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."
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