Actively Recruiting
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
Led by VA Office of Research and Development · Updated on 2026-04-07
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.
CONDITIONS
Official Title
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, male or female
- Definite chronic pancreatitis by M-ANNHEIM criteria including pancreatic calcifications, moderate or marked ductal lesions, marked and persistent exocrine insufficiency improved by enzyme supplementation, or typical histology
- Painful chronic pancreatitis symptoms lasting more than 6 months, either constant or waxing and waning
- Baseline Izbicki pain score greater than 30
- Stable opioid dose for at least 30 days prior to study entry
You will not qualify if you...
- Acute pancreatitis within the last 30 days based on revised Atlanta criteria
- Chronic pain syndromes other than pancreatitis requiring daily opioid use in the past 30 days
- Hemoglobin less than 8.0 g/dL, EGFR less than 60 ml/min, AST or ALT more than twice the upper limit of normal, Bilirubin over 1.5 mg/dl unless Gilbert syndrome
- Platelets less than 100,000/microliter
- HbA1c greater than 10%
- Congestive heart failure NYHA class greater than 1
- History of malignancy except surgically treated in situ cancers and basal cell skin cancers
- Active infection requiring antibiotics or positive for Hepatitis B, C, or HIV
- Known anaphylactic allergy to intravenous contrast
- Ongoing alcohol abuse or illegal drug dependence within past 6 months
- Use of investigational drug or device within 30 days before randomization or planned during study
- Planned endoscopic or surgical pancreatic intervention within next 6 months
- Infected pancreatic pseudocysts or walled-off necrosis at consent
- Pregnant or breastfeeding women, or unwillingness to use contraception when applicable
- Unwillingness to comply with study protocol and assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703
Actively Recruiting
Research Team
L
Leah Benn
CONTACT
A
Alison B Neely
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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