Your session is about to expire
← Back to Search
Cellular Therapy
Cellular Therapy for Chronic Pancreatitis Pain (MSCPainRelief Trial)
Phase 1
Recruiting
Led By Hongjun N Wang, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18 and 75 years old, male or female
Definite chronic pancreatitis (stage 1-3) by M-ANNHEIM criteria
Must not have
Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV
Subject unwilling to follow the protocol and assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, 6 and 12 months
Awards & highlights
Summary
This trial tests if adult stem cells can reduce pain & improve pancreatic function in chronic pancreatitis patients.
Who is the study for?
This trial is for adults aged 18-75 with chronic pancreatitis, experiencing pain for over 6 months and on a stable opioid dose. They must have certain pancreatic conditions confirmed by M-ANNHEIM criteria but can't join if they've had acute pancreatitis recently, high opioid risk, severe anemia or liver issues, uncontrolled diabetes, heart failure, are pregnant/breastfeeding or unwilling to use contraception.
What is being tested?
The study tests mesenchymal stem cells from the patient's bone marrow against a placebo to see if they reduce pain and improve pancreatic function in those with chronic pancreatitis. Participants will be randomly assigned to receive either the stem cells or placebo.
What are the potential side effects?
Potential side effects of mesenchymal stem cell therapy may include reactions at the injection site, fever, allergic reactions, and infection risks. The exact side effects aren't fully known as this is part of what the trial aims to discover.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have been diagnosed with chronic pancreatitis stages 1-3.
Select...
I have been on a stable dose of pain medication for the last 30 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently fighting an infection or have Hepatitis B, C, or HIV.
Select...
I am willing to follow the study's rules and tests.
Select...
I have an infected pancreatic cyst or necrotic area.
Select...
I am currently breastfeeding.
Select...
I am scheduled for a procedure on my pancreas within the next 6 months.
Select...
I have not used any experimental drugs or devices in the last 30 days.
Select...
I am not pregnant or willing to use birth control during the study.
Select...
My heart condition does not limit my physical activity much.
Select...
I have been using opioids daily for a chronic pain condition other than pancreatitis in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, 6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Izbicki pain score (M6 vs. Baseline)
Secondary study objectives
Change in M-Manheim Severity Index absolute score
Change in opioid use as measured in average daily morphine equivalents.
Change in pancreatic volume measured by blinded scoring of MRI
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental CohortExperimental Treatment1 Intervention
MSC
Group II: Validation CohortPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal stem cells
2020
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,030 Total Patients Enrolled
Hongjun N Wang, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was either skin cancer or treated early and surgically.I am scheduled for a procedure on my pancreas within the next 6 months.I am not pregnant or willing to use birth control during the study.I am between 18 and 75 years old.Your hemoglobin, kidney function, liver enzymes, bilirubin, platelet count, and blood sugar levels are below certain levels.Your pain score is higher than 50 before starting the study.I am currently fighting an infection or have Hepatitis B, C, or HIV.I am willing to follow the study's rules and tests.I have an infected pancreatic cyst or necrotic area.I am currently breastfeeding.I have not used any experimental drugs or devices in the last 30 days.My pancreas shows signs of severe damage or changes.I have had chronic pancreatitis pain for over 6 months.I have been diagnosed with chronic pancreatitis stages 1-3.I have been on a stable dose of pain medication for the last 30 days.My heart condition does not limit my physical activity much.You had a severe pancreas inflammation in the last 30 days.You have a high risk of opioid misuse based on a screening tool score.Your TWEAK score is higher than 2 points during the screening.I have been using opioids daily for a chronic pain condition other than pancreatitis in the last 30 days.You have a severe allergy to the contrast dye used in IV injections.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Cohort
- Group 2: Validation Cohort
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger