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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Chronic Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Charleston

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States, 29401-5703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age between 18 and 75 years old, male or female
  • * Definite chronic pancreatitis (stage 1-3) by M-ANNHEIM criteria
  • * 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 \> 50
  • * Stable dose of opioids for the past 30 days
  • * Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days
  • * Score \>7 on the Opioid Risk Tool
  • * 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
  • * TWEAK score \> 2 points at screening (24) (the questions below will be asked of the subjects at screening)
  • * 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 assessments

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Hongjun N Wang, PhD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

2027-12-31