Clinical Trial

A Surgical Procedure (Total Pancreatectomy) With a Transplant Procedure (Islet Cell Autotransplantation) for the Treatment of Chronic Pancreatitis and Benign Pancreatic Tumors

Not Yet Recruiting Phase 1/2
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Summary
This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with long-term pancreatic inflammation (chronic pancreatitis) and non-cancerous (benign) pancreatic tumors. Total removal of the pancreas (pancreatectomy) can be used to treat chronic pancreatitis, but it may result in diabetes. An islet cell autotransplantation involves removing cells from a patient's pancreas (the islet cells) and infusing them into the liver. Islet cells are responsible for producing hormones like insulin, reducing the occurrence of diabetes in patients undergoing total pancreatectomy. Total pancreatectomy with autologous islet cell transplant is an accepted and Food and Drug Administration-approved treatment for patients with chronic pancreatitis. However, patients with chronic pancreatitis and pancreatic tumors have historically not been candidates for this procedure due to concerns of spreading potentially cancerous cells to other parts of the body. This clinical trial evaluates the safety and effectiveness of this treatment in patients with chronic pancreatitis and benign pancreatic tumors.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-07-07; most recent amendment 2025-11-21.
Trial Details
NCT Number NCT05453851
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Conditions Benign Pancreatic Neoplasm, Chronic Pancreatitis, Recurrent Acute Pancreatitis
Enrollment 12 participants
Start Date 2026-07-01
Primary Completion 2029-07-01 (estimated)
Study Completion 2030-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-25