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A Novel Clinical Grade Isolation Method for Human Kidney Perivascular Stromal Cells
Published on: August 7, 2017
Safety and Efficacy Endpoints for Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients
J R Bank1, T J Rabelink2, J W de Fijter1
1Department of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands.
Abstract:
Despite excellent short-term graft survival after renal transplantation, the long-term graft outcome remains compromised. It has become evident that a combination of sustained alloreactivity and calcineurin-inhibitor- (CNI-) related nephrotoxicity results in fibrosis and consequently dysfunction of the graft. New immunosuppressive regimens that can minimize or eliminate side effects, while maintaining efficacy, are required to improve long-term graft survival. In this perspective mesenchymal stromal cells (MSCs) are an interesting candidate, since MSCs have immunosuppressive and regenerative properties. The first clinical trials with MSCs in renal transplantation showed safety and feasibility and displayed promising results. Recently, the first phase II studies have been started. One of the most difficult and challenging aspects in those early phase trials is to define accurate endpoints that can measure safety and efficacy of MSC treatment. Since both graft losses and acute rejection rates declined, alternative surrogate markers such as renal function, histological findings, and immunological markers are used to measure efficacy and to provide mechanistic insight. In this review, we will discuss the current status of MSCs in renal transplantation with a focus on the endpoints used in the different experimental and clinical studies.
Insights
Mesenchymal stromal cells (MSCs) show promise for improving long-term renal transplant outcomes by reducing CNI toxicity and promoting regeneration. Early trials indicate safety and efficacy, with ongoing research focusing on appropriate endpoints.
Area of Science:
- Nephrology
- Immunology
- Regenerative Medicine
Background:
- Long-term renal transplant graft survival is limited by sustained alloreactivity and calcineurin-inhibitor (CNI) nephrotoxicity, leading to fibrosis and dysfunction.
- Novel immunosuppressive strategies are needed to mitigate CNI side effects while preserving efficacy for improved long-term graft survival.
Purpose of the Study:
- To review the current status of mesenchymal stromal cells (MSCs) in renal transplantation.
- To focus on the endpoints used in experimental and clinical studies evaluating MSCs for renal transplantation.
Main Methods:
- Review of existing literature on MSCs in renal transplantation.
- Analysis of endpoints used in early-phase clinical trials (Phase I and II).
- Discussion of safety, feasibility, efficacy, and mechanistic insights.
Main Results:
- Mesenchymal stromal cells (MSCs) possess immunosuppressive and regenerative properties beneficial for renal transplantation.
- Initial clinical trials demonstrate the safety and feasibility of MSCs in this context.
- Promising results have led to the initiation of Phase II studies.
Conclusions:
- Mesenchymal stromal cells (MSCs) represent a promising therapeutic candidate for improving long-term renal transplant outcomes.
- Defining accurate endpoints is crucial for evaluating MSC safety and efficacy in clinical trials.
- Alternative surrogate markers like renal function and immunological markers are essential for assessing MSC treatment effectiveness.
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