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

Exclusion Criteria14

• 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