NCT05095532 Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
| NCT ID | NCT05095532 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Medical University of South Carolina |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2021-12-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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);
Contact & Investigator
Charlton Strange, M.D
STUDY DIRECTOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05095532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05095532 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05095532 currently recruiting?
Yes, NCT05095532 is actively recruiting participants. Contact the research team at bennle@musc.edu for enrollment information.
Where is the NCT05095532 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05095532 clinical trial?
NCT05095532 is sponsored by Medical University of South Carolina. The principal investigator is Charlton Strange, M.D at Medical University of South Carolina. The trial plans to enroll 42 participants.