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

Inclusion Criteria:

• Age between 18 and 75 years old, male or female

• Definite chronic pancreatitis M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or moreof 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 > 30 (Dworkin et al., 2005)

• Stable dose of opioids for the past 30 days

Exclusion Criteria:

• Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 daysoThe revised Atlanta classification requires that two or more of the followingcriteria be met for the diagnosis of acute pancreatitis: (a) abdominal painsuggestive of pancreatitis, (b) serum amylase or lipase level greater than threetimes the upper normal value, or (c) characteristic imaging findings.

• 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

• Any subject who has had an ongoing alcohol abuse and/or illegal drug dependencieswithin the past six months.

• 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 assessment