NCT05925036 Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis
| NCT ID | NCT05925036 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.
Eligibility 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
Contact & Investigator
Hongjun N Wang, PhD
PRINCIPAL INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Frequently Asked Questions
Who can join the NCT05925036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05925036 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05925036 currently recruiting?
Yes, NCT05925036 is actively recruiting participants. Contact the research team at leah.benn@va.gov for enrollment information.
Where is the NCT05925036 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05925036 clinical trial?
NCT05925036 is sponsored by VA Office of Research and Development. The principal investigator is Hongjun N Wang, PhD at Ralph H. Johnson VA Medical Center, Charleston, SC. The trial plans to enroll 40 participants.