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Novel Cellular Therapy for Chronic Pancreatitis Pain

This study is testing a new way to treat pain from chronic pancreatitis, a long-lasting inflammation of the pancreas. Researchers are using mesenchymal stem cells (MSCs), which are adult stem cells taken from a person's own bone marrow. These MSCs will be compared to a placebo (an inactive substance) to see if they can reduce pain and improve how well the pancreas works. You may be able to join if you are between 18 and 75 years old and have chronic pancreatitis based on specific medical criteria. The main goal is to see if your pain, measured by the Izbicki pain score, changes after 6 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 40 participants. It compares mesenchymal stem cells to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at 6 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05925036

Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis

Recruiting
PHASE1Ages 18–75InterventionalTreatment
VA Office of Research and Development
~40 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Mesenchymal stem cellsPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Izbicki pain score (M6 vs. Baseline)
Measured over 6 month

Conditions

Chronic Pancreatitis
Chronic Pain

Explore related trials

Chronic Pancreatitis

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Hongjun N Wang, PhD · PRINCIPAL_INVESTIGATOR · Ralph H. Johnson VA Medical Center, Charleston, SC

Who to contact

Leah Benn
[email protected]
(843) 792-2813
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age between 18 and 75 years old, male or female
Definite chronic pancreatitis M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or more of the following are required:
Pancreatic calcifications
Moderate or marked ductal lesions
Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation
Typical histology of an adequate histological specimen
Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
Baseline Izbicki pain score \> 30 (Dworkin et al., 2005)
Stable dose of opioids for the past 30 days

Exclusion

Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe revised Atlanta classification requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level greater than three times the upper normal value, or (c) characteristic imaging findings.
Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
Hemoglobin of \<8.0g/dL, EGFR\<60 ml/min, AST or ALT \>2 times upper limit of normal, Bilirubin \> 1.5 mg/dl unless the subject has confirmed Gilbert syndrome., Platelets \<100,000/microliter, HbA1c \>10%
Congestive Heart Failure NYHA class \>1
History of Malignancy except for in situ malignancies that have been surgically treated and basal cell skin cancers
Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV
Known intravenous contrast allergy causing anaphylaxis
Any subject who has had an ongoing alcohol abuse and/or illegal drug dependencies within the past six months.
Any subject who has received an investigational drug or device within 30 days before randomization or who is expected to receive an investigational drug or device during this study.
Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.
Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent
Females who are pregnant or women of childbearing potential (WOCBP) and males with female partners of childbearing potential who are not willing to use adequate contraception during the study
Breastfeeding females
Subject unwilling to follow the protocol and assessment

What this trial measures

  • Change in Izbicki pain score (M6 vs. Baseline)6 month

    Change in pain as measured by Izbicki pain scores