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Cell Therapy
Cell Transplant for Type 1 Diabetes (cePolyTregs Trial)
Phase 1
Waitlist Available
Led By James Shapiro, MD/PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent
Subjects must be 18-68 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 58 weeks
Awards & highlights
cePolyTregs Trial Summary
This trial is testing whether a cell transplant can improve outcomes for type 1 diabetes patients by preventing extensive graft damage.
Who is the study for?
This trial is for adults aged 18-68 with Type 1 Diabetes (T1DM) who've had it for over 5 years and struggle with blood sugar control despite trying hard. They should have issues sensing low blood sugar or have been hospitalized for related complications within the last year. Participants need to understand the study, agree to its terms, and not be on certain medications like anticoagulants or planning pregnancy.Check my eligibility
What is being tested?
The trial tests cePolytreg cells in people receiving Islet transplants to manage T1DM. These special cells might help patients accept their new insulin-producing cells without needing lifelong anti-rejection drugs by preventing unwanted immune responses that could damage the transplant.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased risk of infection, possible infusion-related reactions from the cePolytreg treatment, and any unforeseen impacts on organ function.
cePolyTregs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study's risks and have signed the consent form.
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I am between 18 and 68 years old.
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My blood sugar levels are unstable and have led to hospital visits.
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I have had Type 1 Diabetes for over 5 years.
cePolyTregs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 58 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~58 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Stimulated C-peptide level
cePolyTregs Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Participants will receive cePolyTregs (target 400-1600 million, with a minimal acceptable dose of 100 million) two weeks post islet transplant and will be followed for 1 year after cePolyTregs infusion to assess the safety and preliminary efficacy of cePolyTregs therapy.
Group II: ControlActive Control1 Intervention
The Participants in this arm receive islet transplant only and no cePolyTregs.
Find a Location
Who is running the clinical trial?
Juvenile Diabetes Research Foundation Canadian Clinical Trial NetworkUNKNOWN
University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,947 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,773 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's risks and have signed the consent form.I have Graves' disease but have been treated with radioiodine.You are not able to sense when your blood sugar gets too low, or your blood sugar levels are hard to control even with a lot of insulin.I am on long-term steroids for another health issue.I do not have active infections like Hepatitis C, B, HIV, or TB.My cholesterol levels are very high and not under control.You must not have been using alcohol or drugs for the past 6 months before the transplant.Your kidney function is not strong enough, as measured by GFR, a test for how well your kidneys filter waste from your blood.I need more than 1 unit of insulin per kilogram of my body weight daily.I am between 18 and 68 years old.You have trouble noticing when your blood sugar gets too low, and it has caused serious problems in the past year.My blood sugar levels are unstable and have led to hospital visits.Your HbA1C level is higher than 12%.You have had an organ transplant before, or tests show that your body has a strong reaction to foreign tissues.I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.I do not have severe heart problems, recent heart attacks, or very poor heart function.I am suspected to have rapidly worsening kidney problems.I have Celiac disease that has not been treated.You have had a high level of protein in your urine.I understand the study's risks and have signed the consent form.My hemoglobin level is below the normal range for my gender.I have an untreated eye condition where new blood vessels grow abnormally.I have had Type 1 Diabetes for over 5 years.I was diagnosed with Type 1 diabetes after age 40 and have been on insulin for less than 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has cePolytreg been certified by the FDA?
"CePolytreg has only been tested in preliminary clinical trials, so the safety rating is set at 1. This reflects a lack of available data on efficacy and security."
Answered by AI
Are there any current opportunities for patients to enter this clinical trial?
"This clinical trial is actively enrolling, as per the data posted on clinicaltrials.gov. It was originally listed on August 15th 2022 and has been amended most recently September 12th 2022."
Answered by AI
What is the population cap for this research project?
"Affirmative, the information on clinicaltrials.gov attests that this research is actively recruiting patients. This investigation was first uploaded to the platform on August 15th 2022 and has been updated as recently at September 12th 2022. Aspiring participants must be one of 11 volunteers across a single site."
Answered by AI
Does this research project accept individuals over the age of sixty?
"This clinical trial is seeking participants who are within the age range of 18 and 68 years."
Answered by AI
What qualifications must be met in order to participate in this experiment?
"A total of 11 volunteers are necessary for the clinical trial and qualifications necessitate that participants have Type 1 diabetes, as well as be between 18 and 68 years of age."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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