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

ConditionsChronic PancreatitisMesenchymal Stem Cells
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of CP and scheduled for TP-IAT;

≥18 years old;

Diabetes with HbA1c <12%.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Bone marrow-derived mesenchymal stem cells

    Biological/Vaccine

    MSC transplantation

  • Placebo

    Other intervention

    Standard of Care

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: BM-MSCs at 20x10^6Experimental treatment 1 intervention
Group B: BM-MSCs at 50x10^6Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Islet Cell Function

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.

Time frame
1 year

Secondary outcomes

1

Change in HbA1C levels from baseline to 12 months.

Change in HbA1C levels from baseline to 12 months

Time frame
1 year
2

Proportion of insulin-independent patients following IAT

Proportion of insulin-independent patients following IAT

Time frame
1 year
3

Average daily insulin requirement

Average daily insulin requirement

Time frame
1 year
4

Beta cell function as assessed by beta-score

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.

Time frame
1 year

Other outcomes

1

Change in islet function between baseline to day 90±28

Change in islet function between baseline to day 90±28. Islet function will be indicated by area under the curve of C-peptide levels during a mixed meal tolerance test adjusted by islet equivalent number transplanted.

Time frame
90 days
2

Daily oral Morphine Equivalents on day prior to visit

Daily oral Morphine Equivalents on day prior to visit (day 90±28 to day 365±28)

Time frame
9 months
3

Proportion of patients remaining on narcotics

Proportion of patients remaining on narcotics (day 90±28 to day 365±28).

Time frame
9 months
4

Short form (SF)-12 Quality of Life score

SF-12 Quality of Life score, Scores range from 0 to100, with higher scores indicating better physical and mental healthy functioning.

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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