Infusion of stem cells to reduce pain from chronic pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 related to pancreatitis within the last 90 days.

    * In the case that a patient is screen-failed due to this criterion, they may be re-screened after the 90-day period has ended if all other eligibility criteria are met.
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 it's running

• 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
• Email: bennle@musc.edu
• Phone: 843-792-2813

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• One-time Pain Reprocessing Therapy session for chronic pain at The Ottawa Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.