Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Mesenchymal Stem Cells
- Other: Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov