Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT06205342

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

Led by Medical University of South Carolina · Updated on 2026-04-17

48

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old, male or female
  • Definite chronic pancreatitis diagnosis
  • Painful chronic pancreatitis for more than 6 months, which may be constant or waxing and waning
  • Baseline Izbicki pain score greater than 30
  • Stable dose of opioids for the past 30 days
Not Eligible

You will not qualify if you...

  • Acute pancreatitis within the last 30 days based on revised Atlanta criteria
  • Chronic pain syndromes other than pancreatitis requiring daily opioid use in the past 30 days
  • Severe organ failure expected to affect pain outcomes within 6 months
  • HbA1c greater than 10%
  • Low blood counts (WBC below 2.0 cells/10^3, hemoglobin below 8 gm/dl, platelets below 100K cells/10^3)
  • Elevated liver enzymes (AST or ALT more than 3 times upper normal limit) or creatinine over 2.0 mg/dl
  • Congestive heart failure Class 2 or higher
  • Current lung, hematologic, or solid organ malignancy except skin or cervical stage 1 cancers within past 3 years
  • Current infection with hepatitis B, hepatitis C, or HIV
  • Active malignancy except non-melanoma skin cancer
  • Use of investigational drugs or devices within 30 days before randomization or expected during study
  • Planned pancreatic surgery or endoscopic procedures in next 6 months
  • Pancreatic surgery, endoscopic therapy, or hospitalization for pancreatitis within last 90 days
  • Ongoing alcohol or illegal drug abuse within past 6 months
  • Infected pancreatic pseudocysts or walled-off necrotic areas at consent
  • Pregnant or breastfeeding females, or those not using adequate contraception, and males with female partners of childbearing potential not using contraception
  • Unwillingness to follow study protocol and assessments

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

L

Leah Benn, MPH

CONTACT

B

Bridger Scoggins

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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