Pancreatectomy + Islet Transplant for Benign Pancreatic Conditions

Overseen By Brett C Sheppard, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Steroids

Disqualifiers: Liver disease, Metabolic syndrome, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment for individuals with long-term inflammation of the pancreas (chronic pancreatitis) or non-cancerous pancreatic tumors. The treatment involves removing the pancreas (total pancreatectomy) and transferring special cells (islet cells) from the pancreas to the liver to help control blood sugar and reduce diabetes risk. The goal is to determine if this combination is safe and effective for those experiencing constant pain or reduced quality of life due to these pancreatic conditions. Suitable candidates have chronic abdominal pain and have not found relief with other medical treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot use systemically absorbed steroids like prednisone within the prior month. It's best to discuss your specific medications with the trial team.

What prior data suggests that this treatment is safe?

Research has shown that removing the pancreas and reintroducing insulin-producing cells is generally safe for treating chronic pancreatitis. Studies have found that this procedure helps prevent severe diabetes by restoring these important cells to the body. The FDA has approved this method for chronic pancreatitis, indicating it is well-tolerated.

Patients in past studies often reported better control over their blood sugar levels and an improved quality of life. The procedure successfully reduced pain and managed diabetes-related issues. Overall, safety data from previous patients suggest that most people handle the treatment well, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the treatment because it combines a total pancreatectomy with an autologous islet cell transplant, offering a unique approach for benign pancreatic conditions. Unlike standard treatments that might involve managing symptoms with medication or partial pancreas removal, this method aims to eliminate the pancreas while preserving insulin production by transplanting the patient's own islet cells. This dual approach could potentially reduce the risk of diabetes post-surgery, which is a common complication when the entire pancreas is removed. This innovative method not only addresses the underlying condition but also seeks to maintain blood sugar regulation, which is a significant advancement over traditional options.

What evidence suggests that this treatment might be an effective treatment for chronic pancreatitis and benign pancreatic tumors?

Research has shown that removing the pancreas and transplanting islet cells, a procedure participants in this trial will undergo, can effectively treat chronic pancreatitis. This method reduces pain and improves the quality of life for many patients. Islet cells, which produce insulin, are relocated to the liver, lowering the risk of diabetes after pancreas removal. Long-term results suggest that if enough islet cells are transplanted, they function well and prevent transplant failure. This treatment is already approved for chronic pancreatitis and shows promise for those with non-cancerous pancreatic tumors as well. ^{2 3 4 5 6}

Who Is on the Research Team?

Brett C. Sheppard

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with chronic pancreatitis or benign pancreatic tumors who need their pancreas removed but want to avoid diabetes. They must not have diabetes, be able to consent, and have no untreated cancers or liver disease. Pregnant individuals and those using alcohol or tobacco recently are excluded.

Inclusion Criteria

Criterion: You have chronic pancreatitis-related pain and meet specific criteria for surgery. You also need to meet certain health requirements like having a good performance status, life expectancy of more than 2 years, and not having certain active infections. If you are of reproductive age, you need to use birth control before the surgery.

Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed

You must not have diabetes or must have a positive C-peptide test.

Exclusion Criteria

I have had a previous islet cell transplant.

My pancreatic cancer is too widespread for surgery to leave enough healthy pancreas.

My pancreatic tumor was confirmed malignant before therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Islet Cell Autotransplantation
• Total Pancreatectomy

Trial Overview The safety and effectiveness of total pancreatectomy combined with islet cell autotransplantation are being tested. This procedure aims to prevent diabetes after the removal of the pancreas by transplanting the patient's own insulin-producing cells into their liver.

How Is the Trial Designed?

Group I: Treatment (pancreatectomy, autologous islet cell transplant) Experimental Treatment 3 Interventions

Patients undergo total pancreatectomy and autologous islet cell transplant IV over 15-60 minutes on day 1.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4048073/

Morbidity of total pancreatectomy with islet cell auto- ... In pancreatitis, total pancreatectomy (TP) is an effective treatment for refractory pain. Islet cell auto-transplantation (IAT) may mitigate resulting ...

2. hbsn.amegroups.org hbsn.amegroups.org/article/view/133539/html

Long-term results of total pancreatectomy and autologous islet ... These results showed that TPAIT with an adequate islet cell mass could prevent graft failure and ensure a clinically significant level of graft function (mean C ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X2500970X

Advances in Islet Function Replacing Strategies After Total ... Patient satisfaction and cost-effectiveness following total pancreatectomy with islet cell transplantation for chronic pancreatitis. Pancreas ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05453851?cond=pancreatic+cancer

A Surgical Procedure (Total Pancreatectomy) With a ... This phase I/II trial assesses the safety and effectiveness of total pancreatectomy with islet cell autotransplantation for the treatment of patients with ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ags3.12767

Current status of total pancreatectomy with islet ... Total pancreatectomy with islet autotransplantation can remarkably promote pain relief and improve health-related quality of life for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8235694/

Total Pancreatectomy with Autologous Islet Cell ... Total pancreatectomy with autologous islet transplantation (TPAIT) is performed in order to prevent postoperative diabetes and its serious complications.