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

RecruitingEarly phase 1

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Age between 18 and 75 years old, male or female
2. Definite chronic pancreatitis
3. Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
4. Baseline Izbicki pain score \> 30
5. Stable dose of opioids for the past 30 days

Exclusion Criteria:

1. 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.
2. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
3. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
4. HbA1c \>10%
5. 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
6. New York Heart Association Class 2 or higher congestive heart failure
7. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years.
8. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
9. Active malignancy with the exception of non-melanoma skin cancer.
10. 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.
11. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.
12. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days
13. Subjects who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 6 months.
14. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent
15. 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
16. Breastfeeding females
17. Subject unwilling to follow the protocol and assessments

About the study

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.

What is being tested

Sponsor: Medical University of South Carolina · Participants: 48 · Started: Jul 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06205342

Locations in the U.S.

South CarolinaMedical University of South Carolina, Charleston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.