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

RecruitingEarly phase 1NCT06205342
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
Interventions
  • Drug: Mesenchymal Stem Cells
  • Other: Other: Placebo
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date
2024-07-17
Primary completion
2027-06-01
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age between 18 and 75 years old, male or female 2. Definite chronic pancreatitis, using M-ANNHEIM criteria 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: 1. abdominal pain suggestive of pancreatitis, 2. serum amylase or lipase level greater than three times the upper normal value, or 3. 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 \>12% 5. Laboratory values of WBC \< 2.0 cells/10\^3, HgB \< 8gm/dl and platelets \< 50K, AST or ALT \>3 times the upper limit of normal, and Creatine\> 2.0mg/dl. Laboratory valuate may be retested at a later date and if they are no longer exclusionary, the subject may be enrolled. 6. New York Heart Association grade 3 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, C or HIV infection. 9. Active malignancy with the exception of non-melanoma skin cancer. 10. Subjects who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 6 months. 11. 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. 12. Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months. * Cases where participants initially meet inclusion criteria, but subsequently are felt to need a surgical or endoscopic intervention during the study will be reviewed by the medical monitor - as providing optimal care to the patient is the priority. Individuals who do receive these interventions during their 6-month participation in the study will be censored from outcome evaluation. 13. Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization …

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06205342