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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreTrial 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are higher than normal, but it's not due to a benign condition like Gilbert's.I am not using steroids that could affect my blood sugar, except for certain allowed types.I haven't taken diabetes medications like insulin or metformin in the last 30 days.I am approved for a total pancreatectomy and islet autotransplantation at the University of Minnesota.I have a blood clotting disorder or need blood thinners before surgery.My diabetes is not well-controlled, with high blood sugar or A1c levels.I am currently using or plan to use medication that weakens my immune system.I am between 18 and 68 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Intrahepatic and omental pouch islets
- Group 2: Intrahepatic islets alone
- Group 3: Normal Volunteers
Awards:
This trial has 0 awards, including: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.
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