RECRUITING

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

Conditions

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

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.

Official Title

STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

Quick Facts

Study Start:2024-07-17

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06205342

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
1. Age between 18 and 75 years old, male or female 2. Definite chronic pancreatitis 3. Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting. 4. Baseline Izbicki pain score \> 30 5. Stable dose of opioids for the past 30 days	1. Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days. * The 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. 2. Score ≥7 on the Opioid Risk Tool 3. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days. 4. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months. 5. HbA1c \>10% 6. Laboratory values of WBC \<2.0 cells/10\^3, Hemoglobin \<8 gm/dl, and platelets \<100K cells/10\^3, AST or ALT \> 3 times the upper limit of normal, or creatinine \>2.0 mg/dl 7. New York Heart Association Class 2 or higher congestive heart failure 8. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years. 9. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 10. Active malignancy with the exception of non-melanoma skin cancer. 11. TWEAK score ≥ 2 points at screening. 12. 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. 13. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months. 14. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days 15. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent 16. 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 17. Breastfeeding females 18. Subject unwilling to follow the protocol and assessments

Inclusion Criteria

Exclusion Criteria

1. Age between 18 and 75 years old, male or female
2. Definite chronic pancreatitis
3. Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
4. Baseline Izbicki pain score \> 30
5. Stable dose of opioids for the past 30 days

1. Acute pancreatitis per 2012 revised Atlanta criteria within the last 30 days.
* The 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.
2. Score ≥7 on the Opioid Risk Tool
3. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
4. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
5. HbA1c \>10%
6. Laboratory values of WBC \<2.0 cells/10\^3, Hemoglobin \<8 gm/dl, and platelets \<100K cells/10\^3, AST or ALT \> 3 times the upper limit of normal, or creatinine \>2.0 mg/dl
7. New York Heart Association Class 2 or higher congestive heart failure
8. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years.
9. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
10. Active malignancy with the exception of non-melanoma skin cancer.
11. TWEAK score ≥ 2 points at screening.
12. 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.
13. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.
14. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days
15. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent
16. 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
17. Breastfeeding females
18. Subject unwilling to follow the protocol and assessments

Contacts and Locations

Study Contact

Chloe Jacobs

CONTACT

843-792-6388

jacobchl@musc.edu

Leah Benn

CONTACT

(843) 792-2833

bennle@musc.edu

Principal Investigator

Hongjun Wang, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Hongjun Wang, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2024-07-17

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pancreatitis
Chronic Pain