A Phase 1 interventional study of Bone marrow-derived mesenchymal stem cells and Placebo in Chronic Pancreatitis and Mesenchymal Stem Cells, sponsored by Medical University of South Carolina. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Medical University of South Carolina · Phase 1, Interventional, and Treatment
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.
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.
264 studies on the registry are indexed under Pancreatitis, Chronic; 73 are open to participants now.
This study's planned enrollment of 42 is close to the median of 46 across 140 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One time infusion of islets plus BM-MSCs at 20x10\^6/patient, n=14
Biological: Bone marrow-derived mesenchymal stem cells
One time infusion of islets plus BM-MSCs at 50x10\^6/patient, n=14
Biological: Bone marrow-derived mesenchymal stem cells
One time infusion of islets only.
Other: Placebo
MSC transplantation
Standard of Care
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
Change in HbA1C levels from baseline to 12 months.
Change in HbA1C levels from baseline to 12 months
Time frame: 1 year
Proportion of insulin-independent patients following IAT
Proportion of insulin-independent patients following IAT
Time frame: 1 year
Average daily insulin requirement
Average daily insulin requirement
Time frame: 1 year
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
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
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
Proportion of patients remaining on narcotics
Proportion of patients remaining on narcotics (day 90±28 to day 365±28).
Time frame: 9 months
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
Glycemic control measured by area under the curve (AUC) HbA1c through year 1 and the C-peptide AUC and HbA1c AUC through year 1 (measured every three months) as impacted in a multivariate model by the IEQ/kg islets transplanted.
Glycemic control measured by area under the curve (AUC) HbA1c through year 1 and the C-peptide AUC and HbA1c AUC through year 1 (measured every three months) as impacted in a multivariate model by the IEQ/kg islets transplanted.
Time frame: 1 year
Incidence and severity of adverse events and serious adverse events
Incidence and severity of adverse events and serious adverse events
Time frame: 1 year
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of South Carolina