Cell therapy using stem cells to relieve 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 effectiveness of mesenchymal stem cells (MSCs) derived from patients' bone marrow in alleviating pain associated with chronic pancreatitis and improving pancreatic function. The study focuses on veterans suffering from chronic pain, particularly those who have been on stable opioid doses for at least 30 days. By exploring the relationship between inflammation, neuropeptides, and pain, the trial seeks to provide a novel treatment option that could reduce reliance on opioids. Participants will be monitored for pain relief and changes in pancreatic function throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years old, male or female
* Definite chronic pancreatitis M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or more of the following are required:
* Pancreatic calcifications
* Moderate or marked ductal lesions
* Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation
* Typical histology of an adequate histological specimen
* Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning/remitting.
* Baseline Izbicki pain score \> 30 (Dworkin et al., 2005)
* Stable dose of opioids for the past 30 days

Exclusion Criteria:

* Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe 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.
* Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
* Hemoglobin of \<8.0g/dL, EGFR\<60 ml/min, AST or ALT \>2 times upper limit of normal, Bilirubin \> 1.5 mg/dl unless the subject has confirmed Gilbert syndrome., Platelets \<100,000/microliter, HbA1c \>10%
* Congestive Heart Failure NYHA class \>1
* History of Malignancy except for in situ malignancies that have been surgically treated and basal cell skin cancers
* Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV
* Known intravenous contrast allergy causing anaphylaxis
* Any subject who has had an ongoing alcohol abuse and/or illegal drug dependencies within the past six months.
* 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.
* Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.
* Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent
* 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
* Breastfeeding females
* Subject unwilling to follow the protocol and assessment

Where it's running

• Ralph H. Johnson VA Medical Center, Charleston, SC
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Hongjun N Wang, PhD — Ralph H. Johnson VA Medical Center, Charleston, SC
• Study coordinator: Leah Benn
• Email: leah.benn@va.gov
• Phone: (843) 792-2813

Similar studies

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

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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.