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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

Must not have

Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant

Untreated hyperlipidemia - TC > 200 mg/dL, TGC > 200 mg/dL, LDL > 130 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 1 year up to 2 years depending on transplant date

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver tests are normal and I haven't had a rejection episode in the last 6 months.

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My body does not produce c-peptide when stimulated.

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I was diagnosed with Type 1 diabetes before 40 and have been on insulin for over 5 years.

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My kidney function is stable and I haven't had a rejection episode in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low and I've had a rejection episode before a transplant.

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My cholesterol and triglycerides levels are high and untreated.

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I have not treated or unstable eye damage due to diabetes.

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I have severe heart problems, including a recent heart attack, poor heart function, or need for a valve replacement.

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I have developed proteinuria after my kidney transplant.

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My liver tests are high and I've had a rejection episode before a transplant.

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I do not have active infections like hepatitis B, C, HIV, or TB.

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I need more than 1.0 IU/kg/day of insulin.

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I have been diagnosed with a type of hyperparathyroidism.

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I do not have any serious infections.

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I weigh over 100 kg or my BMI is over 30.

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My body has specific antibodies against a donor organ, detected by a special test.

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I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.

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My blood pressure is high even with medication.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 1 year up to 2 years depending on transplant date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin

Incidence of adverse events

Incidence of de novo sensitization

+1 more

Secondary study objectives

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Peter StockLead Sponsor

California Institute for Regenerative Medicine (CIRM)OTHER

69 Previous Clinical Trials

3,354 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.