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Mesenchymal Stem Cells for Chronic Pancreatitis Pain

This study is investigating if Mesenchymal Stem Cells (MSC), which are special cells taken from your own bone marrow, can help reduce the severe pain caused by chronic pancreatitis. Researchers will compare the effects of these MSCs to a placebo (an inactive treatment). You might be eligible if you are between 18 and 75 years old, have definite chronic pancreatitis with pain lasting over six months, and a baseline Izbicki pain score (a measure of pain) greater than 30. Your opioid dose must also have been stable for the past 30 days. The main goal is to see if your pain score improves after 6 months. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 48 participants. It compares Mesenchymal Stem Cells to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months, indicating participants will be followed for at least this duration after treatment.

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NCT06205342

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

Recruiting
EARLY_PHASE1Ages 18–75InterventionalTreatment
Medical University of South Carolina
~48 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Mesenchymal Stem CellsOther: Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Izbicki pain score (M6 vs. Baseline)
Measured over 6 months

Conditions

Chronic Pancreatitis
Chronic Pain

Explore related trials

Chronic Pancreatitis

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

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

Who to contact

Leah Benn, MPH
[email protected]
843-792-2813
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • Change in Izbicki pain score (M6 vs. Baseline)6 months

    Change in pain as measured by Izbicki pain scores, a validated score for pain in chronic pancreatitis, consist of 4 questions, with a range of 0 (no pain) to 100 (severe, debilitating pain).