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Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

NCT03478215 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

  • Renal Transplantation
  • Mesenchymal Stem Cells

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.

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Ahmed O Gaber, MD · Houston Methodist Physicians Organization

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478215 on ClinicalTrials.gov