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

NCT06205342 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: PRO 001329051UG3DK136705-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Izbicki pain score (M6 vs. Baseline)

  Change in pain as measured by Izbicki pain scores, a validated score for pain in chronic pancreatitis, consist of 4 questions, with a range of 0 (no pain) to 100 (severe, debilitating pain).

  6 months

Secondary Outcomes (4)

• Change in pancreatic volume measured by blinded scoring of MRI

  Screening, 6 month

• Change in opioid use as measured in average daily morphine equivalents.

  Screening, 1 month, 3 month, 6 month

• Changes in quality of life

  Screening, 1 month, 3 month, 6 month

• Change in M-Manheim Severity Index absolute score

  Screening, 1 month, 3 month, 6 month

Study Arms (2)

Experimental Cohort

EXPERIMENTAL

MSC

Drug: Mesenchymal Stem Cells

Validation Cohort

PLACEBO COMPARATOR

Placebo

Other: Other: Placebo

Interventions

Mesenchymal Stem Cells DRUG

Autologous bone marrow derived MSCs

Also known as: MSCs

Experimental Cohort

Other: Placebo OTHER

Control

Also known as: Controls

Validation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hongjun Wang, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Benn, MPH

CONTACT

843-792-2813; bennle@musc.edu

Bridger Scoggins

CONTACT

(843) 792-6388; scoggibr@musc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: This is a pilot, randomized, double-blind, placebo-controlled, stratified randomization study to determine the efficacy of a single intravenous infusion of allogeneic bone marrow-derived mesenchymal stromal cells in subjects with painful chronic pancreatitis (CP).

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)