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PolyTreg Immunotherapy for Type 1 Diabetes
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
Subjects must have had T1DM for more than 5 years
Subjects must be 18-68 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 58 weeks
Awards & highlights
Study Summary
This trial is testing a new immunosuppressive treatment for islet transplant patients in order to increase the success rates of the transplant and decrease the side effects.
Who is the study for?
This trial is for adults aged 18-68 with Type 1 Diabetes (T1DM) for over 5 years, who have hypoglycemia unawareness or unstable blood sugar despite trying hard to manage it. They must understand the study and agree to participate. People can't join if they have certain untreated diseases, severe kidney issues, heavy insulin requirements, a history of substance abuse, are pregnant/breastfeeding or planning pregnancy.Check my eligibility
What is being tested?
The trial tests PolyTregs therapy in patients receiving an islet transplant for T1DM. It's an open-label pilot study comparing standard Edmonton induction therapy alone versus with additional PolyTregs infusion post-transplant. The goal is to see if PolyTRegs make the transplant more successful by improving beta cell function and reducing immune system rejection.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts or electrolytes levels due to immunosuppression drugs used during transplantation procedure. There might also be risks associated with intravenous infusions such as infection or inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had Type 1 Diabetes for over 5 years.
Select...
I am between 18 and 68 years old.
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Participants in this arm receive PolyTregs infusion at week 6 post islet transplant.
Group II: ControlActive Control1 Intervention
Participants in this arm receive islet transplant only, and no PolyTregs.
Find a Location
Who is running the clinical trial?
Alberta Diabetes InstituteOTHER
3 Previous Clinical Trials
223 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,766 Total Patients Enrolled
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,760 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have or have had a condition where too much protein is found in your urine.I am pregnant, planning to become pregnant, not using birth control, or breastfeeding.Your HbA1C level is higher than 12%.I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.I have an untreated eye condition where new blood vessels grow abnormally.I have Celiac disease that has not been treated.I have had Type 1 Diabetes for over 5 years.I do not have active infections like Hepatitis C, B, HIV, or TB.I understand the study's risks and have signed the consent form.I am between 18 and 68 years old.I was diagnosed with Type 1 diabetes after age 40 and have been on insulin for less than 5 years.Your kidney function is not strong enough, as measured by GFR less than 60mL/min/1.73 m2.You have been using alcohol or drugs heavily, and need to have stopped for at least 6 months before the transplant.I am suspected to have rapidly worsening kidney problems.You have trouble noticing when your blood sugar gets too low or have unstable metabolism even with careful insulin management.My cholesterol levels are very high and not under control.I am on long-term steroids for another health condition.My hemoglobin level is below the normal range for my gender.I use more than 1 unit of insulin per kilogram of my body weight daily.I have Graves' disease but have been treated with radioiodine.I have a serious heart condition.I have had a transplant or my body has shown a strong immune response.
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 this remedy been given the green light by the Food and Drug Administration?
"The safety of this intervention was classified as a 1 on our scale due to the early stage of the trial, indicating limited data regarding its efficacy and protection."
Answered by AI
Are there any vacancies on this clinical trial for participants?
"The clinicaltrials.gov registry reveals that this trial, initially posted in February 2018 and last updated on September 9th 2022, is no longer recruiting participants. Nevertheless, over 1300 other trials are seeking patient enrolment at the moment."
Answered by AI
Is eligibility for this trial open to me?
"To partake in this research, participants should possess diabetes and autoimmune diseases and must be between 18 to 68 years of age. A total of 18 individuals may take part in the experiment."
Answered by AI
Could octogenarians be considered for eligibility in this research?
"This clinical trial is admitting adults aged between 18 and 68 years old."
Answered by AI
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