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ACTIVE NOT RECRUITING
NCT03478215
PHASE2

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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.

Official title: A Double-blind, Randomized, Controlled Dose Escalation Trial of Autologuous Mesenchymal Stromal Cells in Living Donor Kidney Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2016-12

Completion Date

2026-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

Mesenchymal Stromal Stem Cells (MSCs) Infusion

Investigational infusion bag containing autologous mesenchymal stromal cells wrapped to cover contents to maintain the blind. Mesenchymal Stromal Stem Cells Infusion.

OTHER

Normal Saline (Placebo) Infusion

Matching infusion containing normal saline wrapped to cover contents to maintain the blind. Normal Saline (Placebo) Infusion.

Locations (1)

Houston Methodist Hospital System

Houston, Texas, United States