Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in Chronic Pancreatitis
This study is for people with chronic pancreatitis (CP) who are having a total pancreatectomy with islet autotransplantation (TP-IAT) surgery. It's testing if adding bone marrow-derived mesenchymal stem cells (MSCs) to the standard islet transplant can improve how well the new islet cells work. You would either receive the standard islet transplant (placebo) or the islet transplant with MSCs at one of two different doses. To join, you need to be at least 18 years old, have CP, be scheduled for TP-IAT, and have diabetes with an HbA1c below 12%. People who are pregnant, breastfeeding, or have severe liver damage or are on immunosuppression cannot participate. The main goal is to see how islet cell function changes after one year.
- Study design
- This is a randomized, controlled study with 42 participants. Participants will be assigned to one of three groups: islet transplantation alone (placebo) or islets plus MSCs at two different doses.
- What's involved
- You would have the TP-IAT surgery as planned. After the transplant, you would have three follow-up visits at 90, 180, and 365 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the transplant to assess islet function and other outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charlton Strange, M.D · STUDY_DIRECTOR · Medical University of South Carolina
- William Lancaster, M.D · STUDY_DIRECTOR · Medical University of South Carolina
- Hongjun Wang · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in Islet Cell Function1 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.