NCT06205342 Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
| NCT ID | NCT06205342 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Medical University of South Carolina |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2024-07-17 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: 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. Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days. 3. Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months. 4. HbA1c \>10% 5. 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 6. New York Heart Association Class 2 or higher congestive heart failure 7. Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years. 8. Subjects with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 9. Active malignancy with the exception of non-melanoma skin cancer. 10. 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. 11. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months. 12. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days 13. Subjects who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 6 months. 14. Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent 15. 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 16. Breastfeeding females 17. Subject unwilling to follow the protocol and assessments
Contact & Investigator
Hongjun Wang, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06205342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06205342 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06205342 currently recruiting?
Yes, NCT06205342 is actively recruiting participants. Contact the research team at bennle@musc.edu for enrollment information.
Where is the NCT06205342 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06205342 clinical trial?
NCT06205342 is sponsored by Medical University of South Carolina. The principal investigator is Hongjun Wang, PhD at Medical University of South Carolina. The trial plans to enroll 48 participants.