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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05453851
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pancreatectomy — PROCEDURE
    Undergo pancreatectomy
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Treatment Planning — OTHER
    Undergo IV autologous islet cell transplant

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Nov 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pancreatectomy, autologous islet cell transplant)
    Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.

Primary Outcome Measure

Proportion of patients that are free of metastatic disease to the liver from a pancreatic primary [ Time Frame: From date of surgery to time of identification of metastatic disease from a pancreatic primary, assessed up to 2 years post-surgery or date of death due to metastatic disease of a pancreatic origin ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Brett C. Sheppard
[email protected]
503-494-1502
Brett C. Sheppard (PRINCIPAL_INVESTIGATOR)

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By research site
OHSU Knight Cancer Institute· Portland, OR

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