RecruitingEarly Phase 1

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

United States48 participantsStarted 2024-07-17

Plain-language 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 mechanisms of MSC action.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days.
✕. 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.

What they're measuring

Change in Izbicki pain score (M6 vs. Baseline)

Timeframe: 6 months

Trial details

NCT IDNCT06205342

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Leah Benn, MPH

843-792-2813 bennle@musc.edu

View on ClinicalTrials.gov More Chronic Pancreatitis trials