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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from chronic pancreatitis, a condition that can cause severe, ongoing pain. The researchers want to see if using adult stem cells, specifically mesenchymal stem cells (MSCs) taken from the patient's own bone marrow, can help reduce this pain and improve how the pancreas works. The trial is currently recruiting participants, and it is open to adults aged 18 to 75 who have been diagnosed with chronic pancreatitis and have experienced pain for more than six months.

To participate, individuals must meet certain criteria, such as having specific signs of chronic pancreatitis and a certain level of pain measured by a pain score. Participants in the trial will receive the treatment and will be monitored closely to see how it affects their pain and pancreatic function. It’s important to note that some people may not be eligible due to other health conditions or treatments they may be undergoing. If you or someone you know has chronic pancreatitis and is interested in this trial, it could be an opportunity to explore a potentially beneficial new therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 75 years old, male or female
• • Definite chronic pancreatitis (stage 1-3) by M-ANNHEIM criteria
• 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 \> 50
• • Stable dose of opioids for the past 30 days
• Exclusion Criteria:
• • Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days
• • Score \>7 on the Opioid Risk Tool
• • 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
• • TWEAK score \> 2 points at screening (24) (the questions below will be asked of the subjects at screening)
• • 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 assessments