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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
Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approved for pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committee including surgeons, gastroenterologists specializing in pancreatic disease, a pain specialist psychologist, and endocrinologist to confirm the diagnosis of chronic pancreatitis and candidate suitability for surgery.
Age 18-68
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

iSite Trial 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.Check my eligibility
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.See study design
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.

iSite Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am approved for a total pancreatectomy and islet autotransplantation at the University of Minnesota.
Select...
I am between 18 and 68 years old.

iSite Trial 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

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

iSite 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
1,371 Previous Clinical Trials
1,588,036 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 islets alone, Intrahepatic and omental pouch islets, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper cap of enrollees for this research project?

"Affirmative, the details on clinicaltrials.gov demonstrate that this medical examination is currently recruiting participants. It was initially posted August 1st 2019 and was recently updated September 16th 2022; 45 individuals are sought from a single location."

Answered by AI

Who is the intended demographic for this clinical trial?

"This clinical trial is searching for 45 individuals aged 18 to 68 with a diagnosis of chronic pancreatitis. To be eligible, they must also have been approved and reviewed by the multi-disciplinary committee at the University of Minnesota for total pancreatectomy and IAT. The panel includes surgeons, gastroenterologists focused on pancreatic disease, pain specialists, psychologists, and endocrinologists."

Answered by AI

Has recruitment for this investigation begun?

"According to the records on clinicaltrials.gov, this trial is presently enlisting volunteers. Initially posted on August 1st 2019 and last modified 16th of September 2022, it continues to seek participants for its study."

Answered by AI

Is the eligibility for this research study restricted to adults over the age of twenty?

"This trial has established a minimum age of 18 and an upper limit of 68 for patient inclusion."

Answered by AI
~6 spots leftby Dec 2024