Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT05925036
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesenchymal stem cells — DRUG
    Autologous bone marrow derived MSCs
  • Placebo — OTHER
    Controls

Study Details

The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.

Key Dates

Start date
Jan 1, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Cohort
    MSC
  • Placebo Comparator: Validation Cohort
    Placebo

Primary Outcome Measure

Change in Izbicki pain score (M6 vs. Baseline) [ Time Frame: 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Hongjun N Wang, PhD
843-792-1800
Richard A Schatz, MD
(843) 789-7472
Hongjun N Wang, PhD (PRINCIPAL_INVESTIGATOR)

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