drugset / Trial / NCT02384018
Mesenchymal Stem Cell and Islet Co-transplantation
Phase 1
Completed
3 enrolled
Medical University of South Carolina
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.
Timeline
- Start
- 2014-12
- Primary completion
- 2016-06-01
- Completion
- 2017-11-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous mesenchymal stromal cell | Cell therapy | 2e+07 cells | Other |
| Subject | autologous mesenchymal stromal cell | Cell therapy | 5e+07 cells | Other |
| Subject | autologous mesenchymal stromal cell | Cell therapy | 1e+08 cells | Other |