Recruiting
Phase 1

Cellular Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT05925036

Conditions

Chronic Pancreatitis

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mesenchymal stem cells

Placebo

Study Details

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

Study ID

NCT05925036

Start date

Jan 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 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

Placebo

Controls

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Leah Benn

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

Alison B Neely

(843) 829-2110alison.neely@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Hongjun N Wang, PhD

843-792-1800hongjun.wang@va.gov

Richard A Schatz, MD

(843) 789-7472Richard.Schatz@va.gov

Principal Investigator:

Hongjun N Wang, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-07.