Chronic Pancreatitis, Mesenchymal Stem Cells
Conditions
Keywords
Total Pancreatectomy, TP-IAT
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.
Interventions
MSC transplantation
OTHERPlacebo
Standard of Care
Sponsors
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
This will be a randomized, controlled clinical trial in which CP patients scheduled for TP-IAT who meet the study criteria and consented will be randomized into three groups. One group will receive islet transplantation alone (n=14). The other two groups will receive islets plus BM-MSCs at two different doses (20x10\^6/patient, or 50x10\^6/patient, n=14 in each group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORCharlton Strange, M.D
Medical University of South Carolina
STUDY_DIRECTORWilliam Lancaster, M.D
Medical University of South Carolina
PRINCIPAL_INVESTIGATORHongjun Wang
Medical University of South Carolina
Outcome results
None listed