Status:
RECRUITING
Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Pancreatitis
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mec...
Detailed Description
Chronic pancreatitis (CP) and chronic pain: CP is a debilitating disease characterized by persistent pancreatic inflammation, irreversible morphological changes (fibrosis) in the pancreas and severe c...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years old, male or female
- Definite chronic pancreatitis
- 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 \> 30
- Stable dose of opioids for the past 30 days
Exclusion
- 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.
- Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
- Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
- HbA1c \>10%
- 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
- New York Heart Association Class 2 or higher congestive heart failure
- Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years.
- Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- Active malignancy with the exception of non-melanoma skin cancer.
- 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.
- Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days
- Subjects who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 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
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06205342
Start Date
July 17 2024
End Date
June 1 2028
Last Update
July 30 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425