Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Chronic Pancreatitis, Chronic Pain
In brief
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 mechanisms of MSC action.
Key facts
- Study ID
- NCT06205342
- Run by
- Medical University of South Carolina
- People needed
- 48
- Starts
- 2024-07-17
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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