RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-01

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05925036

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Magdalena N Ardelt

CONTACT

(843) 577-5011

Magdalena.Ardelt@va.gov

Heather N Allen

CONTACT

(843) 608-1950

Heather.Allen6@va.gov

Principal Investigator

Hongjun N Wang, PhD

PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Chronic Pancreatitis
Chronic Pain