Your session is about to expire
← Back to Search
Cell Therapy
Islet + Parathyroid Co-transplant for Type 1 Diabetes (PARADIGM Trial)
Phase 1 & 2
Recruiting
Led By Peter Stock, MD, PhD
Research Sponsored by Peter Stock
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values < 1.5, or total bilirubin < 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant
Recipients should have absent stimulated c-peptide (< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 1 year up to 2 years depending on transplant date
Awards & highlights
PARADIGM Trial Summary
This trial is testing whether it is safe to transplant pancreatic islets along with another organ from the same donor, in people with Type 1 diabetes who have already had a kidney and/or liver transplant. The goal is to see if the islets will engraft and the person will become insulin independent.
Who is the study for?
Adults over 18 with Type 1 diabetes who have had a kidney or liver transplant at least 6 months ago and are on specific immunosuppression drugs. They must not be overweight, have stable organ function without recent rejections, no severe infections or heart issues in the past year, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if putting parathyroid glands (PTG) together with pancreatic islets from the same donor into people with Type 1 diabetes is safe and can help them stop needing insulin shots by allowing the transplanted cells to work properly.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with transplantation such as immune reactions, infection risk increase due to immunosuppressive medications, and possible complications related to surgery.
PARADIGM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver tests are normal and I haven't had a rejection episode in the last 6 months.
Select...
My body does not produce c-peptide when stimulated.
Select...
I was diagnosed with Type 1 diabetes before 40 and have been on insulin for over 5 years.
Select...
My kidney function is stable and I haven't had a rejection episode in the last 6 months.
PARADIGM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum of 1 year up to 2 years depending on transplant date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 1 year up to 2 years depending on transplant date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin
Incidence of adverse events
Incidence of de novo sensitization
+1 moreSecondary outcome measures
Beta cell function as assessed by Insulin-Modified Frequently-Sampled Intravenous Glucose ToleranceTest (FSIGT)
Beta cell function as assessed by Mixed Meal Tolerance Test (MMTT)
Glycemic control
+3 morePARADIGM Trial Design
1Treatment groups
Experimental Treatment
Group I: PTG with adult pancreatic islet co-transplantationExperimental Treatment1 Intervention
People with Type 1 (c-peptide negative) diabetes with stable kidney or liver allografts on chronic immunosuppression who receive study intervention, which is co-transplantation of allogeneic parathyroid (PTG) with adult pancreatic islets in people with Type 1 diabetes in the intramuscular (IM) site
Find a Location
Who is running the clinical trial?
Peter StockLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,140 Total Patients Enrolled
Peter Stock, MD, PhD5.02 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
165 Total Patients Enrolled
5Patient Review
This doctor is not only highly skilled, but also compassionate and caring. It's rare to find such a perfect combination. I feel truly lucky to have found him and would recommend him to anyone.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests are normal and I haven't had a rejection episode in the last 6 months.My kidney function is low and I've had a rejection episode before a transplant.I haven't had serious fungal infections like aspergillus, histoplasmosis, or coccidioidomycosis in the last year.I am 18 years old or older.My cholesterol and triglycerides levels are high and untreated.My body does not produce c-peptide when stimulated.I have not treated or unstable eye damage due to diabetes.I have severe heart problems, including a recent heart attack, poor heart function, or need for a valve replacement.I have developed proteinuria after my kidney transplant.You currently have problems with drinking alcohol or using drugs.I had a kidney or liver transplant over 6 months ago and am on specific immune-suppressing drugs.I have not received any live vaccines in the last 2 months.My liver tests are high and I've had a rejection episode before a transplant.I am not pregnant, breastfeeding, and willing to use effective birth control during and 4 months after the study.I was diagnosed with Type 1 diabetes before 40 and have been on insulin for over 5 years.I do not have active infections like hepatitis B, C, HIV, or TB.I need more than 1.0 IU/kg/day of insulin.I have had cancer after a kidney or liver transplant, but skin cancer was fully removed.I have been diagnosed with a type of hyperparathyroidism.I do not have any serious infections.I weigh over 100 kg or my BMI is over 30.My body has specific antibodies against a donor organ, detected by a special test.My kidney function is stable and I haven't had a rejection episode in the last 6 months.I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.My blood pressure is high even with medication.You have a positive test for BK virus in your blood at the time of screening.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PTG with adult pancreatic islet co-transplantation
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.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT03977662 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What desired outcomes underpin this clinical trial?
"This clinical trial is designed to measure the incidence of adverse events over a minimum one year period, with some participants tracked for up to two years. Secondary objectives include assessing beta cell function via Mixed Meal Tolerance Test (MMTT) and Fast-stimulated Glucose Insulin Tolerance Test (FSIGT), gauging glycemic lability through Mean Amplitude of Glycemic Excursions (MAGE) testing, and measuring hypoglycemia frequency/severity using a HYPO score."
Answered by AI
How many individuals have volunteered to participate in this medical investigation?
"Affirmative. Clinicaltrials.gov supplies details indicating that the trial, which was first made available on July 1st 2019, is presently accepting participants. Specifically, 8 patients must be recruited across a solitary medical facility."
Answered by AI
Is there still capacity for individuals to join this experiment?
"Affirmative. The study, initially published on July 1st 2019 and recently revised on July 7th 2022, is still actively recruiting 8 people across one location according to information hosted by clinicaltrials.gov."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to make a difference.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger