Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05095532
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bone marrow-derived mesenchymal stem cells — BIOLOGICAL
    MSC transplantation
  • Placebo — OTHER
    Standard of Care

Study Details

This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.

Key Dates

Start date
Dec 1, 2021
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: BM-MSCs at 20x10^6
    One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14
  • Experimental: BM-MSCs at 50x10^6
    One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14
  • Placebo Comparator: Placebo
    One time infusion of islets only.

Primary Outcome Measure

Change in Islet Cell Function [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Leah Benn, MPH
[email protected]
843-792-2813

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By research site
Medical University of South Carolina· Charleston, SC

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