Infusion of stem cells to reduce pain from chronic pancreatitis

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

This study is testing whether infusing stem cells can help reduce pain for people suffering from chronic pancreatitis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT06205342 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) in alleviating pain associated with chronic pancreatitis. Participants will receive either the stem cell infusion or a placebo, and the study will explore the mechanisms by which these cells may reduce pain. Chronic pancreatitis is a debilitating condition characterized by severe pain and inflammation, and current treatment options often lead to opioid dependence. The trial will include patients aged 18 to 75 who have been diagnosed with chronic pancreatitis and have experienced pain for over six months.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of chronic pancreatitis and a high baseline pain score.

Not a fit: Patients with acute pancreatitis or those with chronic pain syndromes requiring daily opioid use may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from chronic pancreatitis, potentially reducing reliance on opioids.

How similar studies have performed: While the use of mesenchymal stem cells in pain management is an emerging field, this specific application for chronic pancreatitis pain is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Hongjun Wang, PhD — Medical University of South Carolina
• Study coordinator: Leah Benn, MPH

Conditions Chronic Pancreatitis; Chronic Pain