Phase
Condition
Chronic Pain
Pancreatitis
Pain
Treatment
Placebo
Mesenchymal stem cells
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 steatorrheamarkedly 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 ormay have been waxing and waning/remitting.
Baseline Izbicki pain score > 50
Stable dose of opioids for the past 30 days
Exclusion
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 inthe 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 surgicallytreated and basal cell skin cancers
Evidence of active infection using current antibiotics or with Hepatitis B, C, orHIV
Known intravenous contrast allergy causing anaphylaxis
TWEAK score > 2 points at screening (24) (the questions below will be asked of thesubjects at screening)
Any subject who has received an investigational drug or device within 30 days beforerandomization or who is expected to receive an investigational drug or device duringthis study.
Patients with planned endoscopic or surgical intervention, surgical resection orneedle drainage of pancreatic structures in the next 6 months.
Subjects with infected pancreatic pseudocysts or pancreatic walled-off necroticareas at the time of consent
Females who are pregnant or women of childbearing potential (WOCBP) and males withfemale partners of childbearing potential who are not willing to use adequatecontraception during the study
Breastfeeding females
Subject unwilling to follow the protocol and assessments
Study Design
Study Description
Connect with a study center
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina 29401-5703
United StatesActive - Recruiting
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