Recruiting
Early Phase 1

Mesenchymal Stem Cells

Sponsor:

Medical University of South Carolina

Code:

NCT06205342

Conditions

Chronic Pancreatitis

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mesenchymal Stem Cells

Other: Placebo

Study Details

Brief 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.

Conditions

Chronic Pancreatitis

Chronic Pain

Study ID

NCT06205342

Start date

Jul 17, 2024

Status verified date

Apr, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Cohort

MSC

placebo comparator: Validation Cohort

Placebo

Interventions

Mesenchymal Stem Cells

Autologous bone marrow derived MSCs

Other: Placebo

Control

Primary outcome measure

  • Change in Izbicki pain score (M6 vs. Baseline) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Hongjun Wang, Ph.D.

843-792-1800wangho@musc.edu

Charlton Strange III, MD

(843) 792-3174strangec@musc.edu

Principal Investigator:

Hongjun Wang, Ph.D.

More Information

Sponsor

Medical University of South Carolina

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-04-17.