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

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Brief Title

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

Official Title

Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation

Brief Summary

      This is a clinical trial for non-diabetic 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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Change in Islet Cell Function

Secondary Outcome

 Change in HbA1C levels from baseline to 12 months.

Condition

Chronic Pancreatitis

Intervention

Bone marrow-derived mesenchymal stem cells

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

42

Start Date

December 1, 2021

Completion Date

June 30, 2026

Primary Completion Date

June 30, 2026

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of CP and scheduled for TP-IAT;

          -  ≥18 years old;

          -  Diabetes-free before surgery as defined by the standards of the American Diabetes
             Association*.

          -  No previous major pancreatic surgeries. Patients who have had minor surgeries
             including transduodenal sphincteroplasty or Whipple/Beger procedure are eligible.

        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);

          -  Patients who have had prior pancreatic surgeries including distal pancreatectomy or
             lateral pancreaticojejunostomy. We have observed that islet yield and function are
             negatively correlated with these types of pancreatic surgeries.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Charlton Strange, M.D, 843-792-6280, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05095532

Organization ID

Pro00099487

Secondary IDs

R01DK126454

Responsible Party

Principal Investigator

Study Sponsor

Medical University of South Carolina

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Charlton Strange, M.D, Study Director, Medical University of South Carolina


Verification Date

March 2022