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NCT05095532 · ClinicalTrials.gov registry record · Phase 1
Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
A Phase 1 study of Chronic Pancreatitis and Mesenchymal Stem Cells, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT05095532: Recruiting Phase 1 study of Chronic Pancreatitis and Mesenchymal Stem Cells, sponsored by Medical University of South Carolina.
NCT05095532 is a Phase 1 study of Chronic Pancreatitis and Mesenchymal Stem Cells that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 42 participants, below the 688-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05095532, a Phase 1 study of Chronic Pancreatitis and Mesenchymal Stem Cells, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Bone marrow-derived mesenchymal stem cells
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What NCT05095532 shows while recruiting
NCT05095532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 688-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Chronic Pancreatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05095532 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05095532 about?
NCT05095532 is a clinical study titled "Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT". 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...
What is the current status of trial NCT05095532?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-12-01. Estimated completion is 2027-06-30.
What conditions does trial NCT05095532 study?
This clinical trial studies the following conditions: Chronic Pancreatitis, Mesenchymal Stem Cells.
What interventions are being tested in trial NCT05095532?
The interventions under investigation include: Placebo (OTHER), Bone marrow-derived mesenchymal stem cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05095532?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05095532 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05095532's enrollment target sits among peer trials
42 26th of 42 higher than 17 of 42 other Chronic Pancreatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pancreatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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