Cell therapy using stem cells to relieve pain from chronic pancreatitis
Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
This study is testing if using stem cells from veterans' bone marrow can help relieve pain from chronic pancreatitis and improve how their pancreas works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05925036 on ClinicalTrials.gov |
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.
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 significant pain levels.
Not a fit: Patients with acute pancreatitis or chronic pain syndromes unrelated to pancreatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improve the quality of life for patients suffering from chronic pancreatitis.
How similar studies have performed: While the use of MSCs for pain management is a novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.