RecruitingEarly Phase 1NCT06205342

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

STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

Sponsor

Medical University of South Carolina

Enrollment

48 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Chronic Pancreatitis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria18

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