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Safety and Efficacy of Mesenchymal Stem Cells Associated with Chronic Pancreatitis Pain (STEMCAP-1)

Chronic Pancreatitis (CP) is a debilitating disease characterized by persistent pancreatic inflammation, irreversible morphological changes (fibrosis) in the pancreas, and severe chronic pain. During disease progression, there is a progressive loss of both exocrine and endocrine functions. The incidence of CP varies worldwide, ranging from 1.6 to 23 cases per 100,000 people per year, and it is likely underdiagnosed in the general population. In the United States, CP leads to more than 122,000 outpatient visits and over 56,000 hospitalizations annually. The poorly understood pathophysiology of CP makes it difficult to identify effective treatments for the underlying cellular disorder. This is a nonsurgical trial aimed at investigating whether the presence of mesenchymal stem cells (MSCs) can have a positive impact on pain control for CP patients. 
 

The study aims to enroll 48 CP patients, with stem cells sourced from bone marrow donated by healthy adults who have been extensively screened for infectious diseases. The bone marrow will be processed to produce stem cells. Participants will be randomly assigned to either the treatment group (receiving stem cells) or the placebo group (receiving no stem cells), with a 50/50 chance of being placed in either group. The placebo group serves as a control. After randomization, participants will receive a one-time infusion of their assigned treatment via IV. Following the infusion, participants will be monitored by the research team for 6 months.


The clinical trial registration number for this study is NCT06205342.

Trial Eligibility

Participants are eligible if:

  • Are 18-75 years old: male or female

  • Have been diagnosed with Chronic Pancreatitis

  • Have been experiencing chronic pain for more than 6 months

Currently Enrolling Participants

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