Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

Eligibility Criteria

• 1. Age between 18 and 75 years old, male or female
• 2. Definite chronic pancreatitis
• 3. Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
• 4. Baseline Izbicki pain score \> 30
• 5. Stable dose of opioids for the past 30 days
• 1. Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days.
• * The 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.
• 2. Score ≥7 on the Opioid Risk Tool
• 3. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
• 4. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
• 5. HbA1c \>10%
• 6. Laboratory values of WBC \<2.0 cells/10\^3, Hemoglobin \<8 gm/dl, and platelets \<100K cells/10\^3, AST or ALT \> 3 times the upper limit of normal, or creatinine \>2.0 mg/dl
• 7. New York Heart Association Class 2 or higher congestive heart failure
• 8. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years.
• 9. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
• 10. Active malignancy with the exception of non-melanoma skin cancer.
• 11. TWEAK score ≥ 2 points at screening.
• 12. 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.
• 13. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.
• 14. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days
• 15. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent
• 16. 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
• 17. Breastfeeding females
• 18. Subject unwilling to follow the protocol and assessments