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

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 1

Conditions: Chronic Pancreatitis; Mesenchymal Stem Cells

Treatments: Other: Placebo; Biological: Bone marrow-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05095532

Pro00099487

R01DK126454 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10^6/patient, or 50x10^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of CP and scheduled for TP-IAT;
• ≥18 years old;
• Diabetes with HbA1c <12%.

Exclusion criteria

• Patients who are under immunosuppression;
• Pregnant and breastfeeding women.
• Patients who have liver damage based on ALT, AST, and total bilirubin levels (>3 times normal levels);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

BM-MSCs at 20x10^6

Experimental group

Description:

One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14

Treatment:

Biological: Bone marrow-derived mesenchymal stem cells

BM-MSCs at 50x10^6

Experimental group

Description:

One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14

Treatment:

Biological: Bone marrow-derived mesenchymal stem cells

Placebo

Placebo Comparator group

Description:

One time infusion of islets only.

Treatment:

Other: Placebo