Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis

NCT05925036 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: NURP-003-22FI01CX002516
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.

Conditions

Chronic Pancreatitis; Chronic Pain

Keywords

Mesenchymal stem cells (MSCs); Chronic pancreatitis; Pain relief; Pancreas dysfunction; Fibrosis

Outcome Measures

Primary Outcomes (1)

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

  Change in pain as measured by Izbicki pain scores

  6 month

Secondary Outcomes (4)

• Change in pancreatic volume measured by blinded scoring of MRI

  Screening, 6 months and 12 months

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

  Screening, 6 and 12 months

• Change in quality of life

  Screening, 6 and 12 months

• Change in M-Manheim Severity Index absolute score

  Screening, 6 and 12 months

Study Arms (2)

Experimental Cohort

EXPERIMENTAL

MSC

Drug: Mesenchymal stem cells

Validation Cohort

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Mesenchymal stem cells DRUG

Autologous bone marrow derived MSCs

Also known as: MSCs

Experimental Cohort

Placebo OTHER

Controls

Also known as: Control

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 M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or more of the following are required:
• Pancreatic calcifications
• Moderate or marked ductal lesions
• Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation
• Typical histology of an adequate histological specimen
• 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 (Dworkin et al., 2005)
• Stable dose of opioids for the past 30 days

You may not qualify if:

• Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe 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.
• Hemoglobin of \<8.0g/dL, EGFR\<60 ml/min, AST or ALT \>2 times upper limit of normal, Bilirubin \> 1.5 mg/dl unless the subject has confirmed Gilbert syndrome., Platelets \<100,000/microliter, HbA1c \>10%
• Congestive Heart Failure NYHA class \>1
• History of Malignancy except for in situ malignancies that have been surgically treated and basal cell skin cancers
• Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV
• Known intravenous contrast allergy causing anaphylaxis
• Any subject who has had an ongoing alcohol abuse and/or illegal drug dependencies within the past six months.
• 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.
• 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 assessment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain; Fibrosis

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 N Wang, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena N Ardelt

CONTACT

(843) 577-5011; Magdalena.Ardelt@va.gov

Leah Benn

CONTACT

(843) 792-2813; leah.benn@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of a single intravenous infusion of autologous bone marrow-derived mesenchymal stromal cells in subjects with painful chronic pancreatitis.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)