Islet Transplant Techniques for Chronic Pancreatitis

(iSite Trial)

Overseen By Kristine Mulier

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Insulin, Metformin, Corticosteroids, others

Disqualifiers: Diabetes, Liver disease, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Randomized pilot trial of patients (n=30) undergoing Total Pancreatectomy and Islet AutoTransplant (TPIAT). Patients with islet harvest of greater than 5000 islet equivalents/kg body weight will be randomized to receive a portion of their islets into an omental pouch. For outcomes related to islet function, a group of normal volunteers (n=15) will be studied as a comparator group.

Who Is on the Research Team?

Greg Beilman, MD

Principal Investigator

University of Minnesota, Department of Surgery

Are You a Good Fit for This Trial?

This trial is for adults aged 18-68 who are scheduled for total pancreatectomy and Islet AutoTransplant at the University of Minnesota, without pre-existing diabetes or certain blood sugar levels. They must be able to consent and not have used specific diabetes treatments recently, steroids that affect glucose tolerance, or have severe anemia, low platelets/neutrophils.

Inclusion Criteria

I am approved for a total pancreatectomy and islet autotransplantation at the University of Minnesota.

Able to provide informed consent

Exclusion Criteria

My liver enzymes are higher than normal, but it's not due to a benign condition like Gilbert's.

Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL), thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).

Any other medical condition that , in the opinion of the investigator, may interfere wit the patient's ability to successfully and safely complete the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Islet Transplantation

Participants undergo total pancreatectomy and islet autotransplantation, with randomization to intra-portal alone or intra- and extra-portal transplantation

Immediate post-operative period

Inpatient stay for surgery and recovery

Post-operative Monitoring

Participants are monitored for surgical complications and portal vein thrombosis using abdominal ultrasound

4-5 days

Daily inpatient monitoring

Follow-up

Participants are monitored for safety and effectiveness, including glucose monitoring and hypoglycemic episodes

1 year

Regular outpatient visits and continuous glucose monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Intrahepatic islets alone
• Intrahepatic islets and islets in the omental pouch

Trial Overview The study tests two methods of pancreatic islet transplantation in patients undergoing surgery for chronic pancreatitis: one group receives islets into their liver (intrahepatic) and another group gets them both in the liver and an omental pouch. A control group of normal volunteers will help compare outcomes related to islet function.

How Is the Trial Designed?

Group I: Intrahepatic and omental pouch islets Experimental Treatment 1 Intervention

Group II: Intrahepatic islets alone Active Control 1 Intervention

Group III: Normal Volunteers Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+