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Islet Transplantation

Islet Transplant Techniques for Chronic Pancreatitis (iSite Trial)

N/A
Recruiting
Led By Greg Beilman, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year

Summary

This trial is testing whether or not it's better to transplant islets into the omentum (a fold of the peritoneum) or leave them in the liver. They will compare islet function in patients to a group of normal volunteers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't specified but may include complications from surgical procedures such as infection or bleeding, immune reactions to transplanted cells, changes in blood sugar levels requiring management, and any medication-related adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clarke score
Clavien-Dindo classification of surgical complications
Continuous glucose monitoring
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intrahepatic and omental pouch isletsExperimental Treatment1 Intervention
Group II: Intrahepatic islets aloneActive Control1 Intervention
Group III: Normal VolunteersPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,657 Total Patients Enrolled
Greg Beilman, MDPrincipal InvestigatorUniversity of Minnesota, Department of Surgery

Media Library

Intrahepatic islets alone (Islet Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT03779139 — N/A
Islet Cell Transplantation Research Study Groups: Intrahepatic and omental pouch islets, Intrahepatic islets alone, Normal Volunteers
Islet Cell Transplantation Clinical Trial 2023: Intrahepatic islets alone Highlights & Side Effects. Trial Name: NCT03779139 — N/A
Intrahepatic islets alone (Islet Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03779139 — N/A
~1 spots leftby Dec 2024