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

Phase 1

Recruiting

• Conditions: Chronic Pancreatitis; Mesenchymal Stem Cells
• Interventions: Biological: Bone marrow-derived mesenchymal stem cells; Other: Placebo

• Registration Number: NCT05095532
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-27
• Study Start: 2021-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM-MSCs at 50x10^6	Bone marrow-derived mesenchymal stem cells	One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14
Placebo	Placebo	One time infusion of islets only.
BM-MSCs at 20x10^6	Bone marrow-derived mesenchymal stem cells	One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14

Primary Outcome Measures

Name	Time	Method
Change in Islet Cell Function	1 year	The primary endpoint will be change in islet function between baseline and 12 months as measured by area under the curve of C-peptide levels during a mixed meal tolerance test (MMTT) adjusted by islet equivalent number (IEQ) transplanted.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1C levels from baseline to 12 months.	1 year	Change in HbA1C levels from baseline to 12 months
Proportion of insulin-independent patients following IAT	1 year	Proportion of insulin-independent patients following IAT
Average daily insulin requirement	1 year	Average daily insulin requirement
Beta cell function as assessed by beta-score	1 year	β-score is an assessment of beta cell function after islet transplantation incorporating fasting plasma glucose levels, HbA1c, daily insulin, and stimulated c-peptide. The range of the score is from 0 to 8. Higher number means better beta cell transplant function.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States