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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
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

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 below
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I am between 18 and 75 years old.
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I have been diagnosed with chronic pancreatitis stages 1-3.
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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:
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I am currently fighting an infection or have Hepatitis B, C, or HIV.
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I am willing to follow the study's rules and tests.
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I have an infected pancreatic cyst or necrotic area.
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I am currently breastfeeding.
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I am scheduled for a procedure on my pancreas within the next 6 months.
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I have not used any experimental drugs or devices in the last 30 days.
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I am not pregnant or willing to use birth control during the study.
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My heart condition does not limit my physical activity much.
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I have been using opioids daily for a chronic pain condition other than pancreatitis in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, 6 and 12 months for reporting.

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 more

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
1,664 Previous Clinical Trials
3,765,743 Total Patients Enrolled
42 Trials studying Chronic Pain
5,132 Patients Enrolled for Chronic Pain
Hongjun N Wang, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC

Media Library

Mesenchymal stem cells (Cellular Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05925036 — Phase 1
Chronic Pain Research Study Groups: Experimental Cohort, Validation Cohort
Chronic Pain Clinical Trial 2023: Mesenchymal stem cells Highlights & Side Effects. Trial Name: NCT05925036 — Phase 1
Mesenchymal stem cells (Cellular Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925036 — Phase 1
~27 spots leftby Dec 2026
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