Clinical Trial

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Active, Not Recruiting Phase 2

Record status

This record was last updated March 14, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Summary

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients receive induction therapy and immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. This research study will evaluate the safety and activity of mesenchymal stromal stem cells (MSCs) infusion compared to saline-only infusion in reducing the immune suppression necessary to achieve optimal renal function in renal transplant recipients. All participants will receive routine care: basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.

Protocol Amendment History 5 amendments

This ClinicalTrials.gov record has been amended 5 times since 2018-03-20; most recent amendment 2025-03-12.

Status change: Recruiting → Active, Not Recruiting 2025-03-12

Trial Details

NCT Number	NCT03478215
Lead Sponsor	The Methodist Hospital Research Institute Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions	Renal Transplantation, Mesenchymal Stem Cells
Enrollment	24 participants
Start Date	2016-12
Primary Completion	2025-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-14