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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, 6 and 12 months
Awards & highlights
MSCPainRelief Trial 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.Check my eligibility
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.See study design
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.
MSCPainRelief Trial 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.
MSCPainRelief Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Izbicki pain score (M6 vs. Baseline)
Secondary outcome measures
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 moreMSCPainRelief 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
2020
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,244 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting volunteers for this trial?
"The records on clinicaltrials.gov display that enrollment in this medical trial is not currently open; however, the original post was issued on January 1st 2024 and the last update happened June 20th 2023. Although this specific study is not actively recruiting participants, there are 485 other trials with openings at present."
Answered by AI
Can adults of legal age participate in this medical research?
"To join this research project, patients need to be aged between 18 and 75. Separately, there are 49 trials for those younger than 18 years old and 437 studies available for participants over the age of 65."
Answered by AI
Am I eligible to be part of this research?
"To be eligible for this trial, applicants must have chronic pancreatitis and reside in the age range of 18 to 75. Presently, 40 participants are being sought after by the clinical study's staff."
Answered by AI
Has the Experimental Cohort undergone approval from the FDA?
"The safety and efficacy of Experimental Cohort is unknown, thus it was given a 1 on the Power scale. This rating reflects that this trial is in its first phase with limited data available to assess probable outcomes."
Answered by AI
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