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Cell Therapy

Islet Transplantation for Type 1 Diabetes

Phase 1
Waitlist Available
Led By Andrew M Posselt, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must 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
Clinical history compatible with T1D (onset < 40 yrs old and insulin dependent for > 5 yrs at enrollment)
Must not have
Blood Pressure: SBP > 160 mmHg or DBP >100 mmHg despite treatment with antihypertensive agents
Active peptic ulcer disease or gastritis, symptomatic gallstones, or portal hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to transplant islets in people with type I diabetes who have received a kidney transplant. Up to 6 patients will be enrolled and followed for 3 years.

Who is the study for?
This trial is for adults aged 18-70 with Type 1 Diabetes who have had a kidney transplant and are on specific immunosuppression drugs. They must have stable renal function, a history of severe hypoglycemia despite intensive diabetes management, and no production of c-peptide. Exclusions include active infections like hepatitis or HIV, recent use of other anti-diabetic drugs or investigational agents, certain cardiovascular conditions, untreated hyperlipidemia, pregnancy or unwillingness to use contraception.
What is being tested?
The study tests the safety and effectiveness of transplanting islet cells into the stomach's lining in people with Type 1 Diabetes who've had a kidney transplant. Six patients will be enrolled to receive this treatment and monitored for up to three years post-transplant.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection or bleeding at the transplantation site, immune reactions against the transplanted cells leading to inflammation or organ damage, and possible medication-related issues due to immunosuppressants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My c-peptide levels are very low after a special drink test.
Select...
I was diagnosed with Type 1 Diabetes before 40 and have been on insulin for over 5 years.
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I am between 18 and 70 years old.
Select...
I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is still high despite taking medication.
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I have an active stomach ulcer, symptomatic gallstones, or high blood pressure in the liver.
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I use more than 1.0 IU/kg/day or less than 15 units/day of insulin.
Select...
I have serious heart problems, including a recent heart attack or weak heart muscle.
Select...
I am using glucocorticoids for reasons other than a transplant.
Select...
I weigh over 100 kg or my BMI is over 30.
Select...
I have developed proteinuria after my kidney transplant.
Select...
I have pancreatitis.
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My cholesterol and triglycerides levels are high and untreated.
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I do not have any active infections, except for mild skin or nail fungus.
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I have had cancer before, but it was completely removed except for skin cancer.
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I haven't taken any diabetes medication except insulin in the last 4 weeks.
Select...
My kidney function is low, with a GFR of 40 mL/min/1.73 m2 or less.
Select...
I have untreated or worsening eye damage due to diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 independence
Secondary study objectives
Changes (reduction) in insulin requirements
Changes in HbA1c
Incidence of adverse events

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: Islet TransplantExperimental Treatment2 Interventions
Islet transplantation into the gastrointestinal submucosa

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,947 Total Patients Enrolled
Andrew PosseltLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Andrew M Posselt, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Islet cells (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02402439 — Phase 1
Type 1 Diabetes Research Study Groups: Islet Transplant
Type 1 Diabetes Clinical Trial 2023: Islet cells Highlights & Side Effects. Trial Name: NCT02402439 — Phase 1
Islet cells (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02402439 — Phase 1
~0 spots leftby Dec 2025
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