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Cell Therapy
Mesenchymal Stem Cells for Chronic Pancreatitis (STEMCAP-1 Trial)
Phase < 1
Recruiting
Led By Hongjun Wang, PhD
Research Sponsored by Medical University of South Carolina
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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, 1 month, 3 month, 6 month
Summary
This trial will test if an infusion of a specific type of cells can help reduce pain in people with chronic pancreatitis. It will also study how these cells work to reduce pain.
Who is the study for?
This trial is for individuals with chronic pancreatitis who experience ongoing pain. Participants should be adults who meet specific health criteria and have not responded well to standard pain treatments.
What is being tested?
The study is testing the safety and effectiveness of mesenchymal stem cells (MSCs) derived from bone marrow in reducing chronic pancreatitis pain, compared to a placebo.
What are the potential side effects?
Possible side effects may include reactions at the infusion site, fever, allergic responses, or body aches. The full range of side effects will be studied.
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.
Select...
My opioid medication dose has been the same for the last 30 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for a procedure on my pancreas within the next 6 months.
Select...
I have an infection in my pancreas due to pseudocysts or necrosis.
Select...
I am not pregnant or willing to use birth control during the study.
Select...
I am currently breastfeeding.
Select...
I am willing to follow the study's rules and tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, 1 month, 3 month, 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, 1 month, 3 month, 6 month
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 moreSide effects data
From 2021 Phase 1 & 2 trial • 10 Patients • NCT0335682110%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesenchymal Stem Cells
Trial 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
2016
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
979 Previous Clinical Trials
7,400,917 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,405 Total Patients Enrolled
Hongjun Wang, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
60 Total Patients Enrolled