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Tests treatment safety and results for Chronic Pancreatitis
Official title Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain
ClinicalTrials.gov ID: NCT06205342
What this study is testing
What is Mesenchymal Stem Cells?
Mesenchymal Stem Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic pancreatitis.
Also referred to as MSCs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC action.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 and 75 years old, male or female
- Definite chronic pancreatitis
- 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
- Stable dose of opioids for the past 30 days
You likely can't join if
- 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...
- Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
- Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
- HbA1c \>10%
- Laboratory values of WBC \ 3 times the upper limit of normal, or creatinine \>2.0 mg/dl
See the full eligibility criteria
- Age between 18 and 75 years old, male or female
- Definite chronic pancreatitis
- 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
- Stable dose of opioids for the past 30 days
- 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...
- Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.
- Severe organ failure(s) likely to interfere with clinical pain outcomes within 6 months.
- HbA1c \>10%
- Laboratory values of WBC \ 3 times the upper limit of normal, or creatinine \>2.0 mg/dl
- New York Heart Association Class 2 or higher congestive heart failure
- Current lung, hematologic, or solid organ malignancy other than skin, or cervical stage 1 cancers within the past 3 years.
- people with current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- Active malignancy with the exception of non-melanoma skin cancer.
- 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.
- Patients who have had a pancreatic surgery, endoscopic procedure with therapy, or hospitalization related to pancreatitis within the last 90 days
- people who have had any ongoing alcohol abuse and/or any illegal drug abuse within the past 6 months.
- people 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 assessments
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.