Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03478215 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Dec 2023 to Dec 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 2023 to Dec 2026 · Site details revisedv6 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 2023 to Dec 2026
    • Site details revised
  2. Primary and study completion dates: Jul 2021 to Dec 2023 Start date: Feb 2016 to Dec 2016v5 Show 1 more changeShow less
    • Start date: Feb 2016 to Dec 2016
  3. Re-verified, no change to tracked fieldsv4
  4. Lead sponsor: Ahmed Osama Gaber, MD to The Methodist Hospital Research Institute Collaborators: 2 to 1v3 Show 1 more changeShow less
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jul 2018 to Jul 2021 Completion date: Jul 2019 to Jul 2021 · Interventions: Basiliximab (Drug), Mycophenolate Mofetil (Drug), Tacrolimus (Drug) to Mesenchymal Stromal Stem Cells (MSCs) Infusion (Biological), Normal Saline (Placebo) Infusion (Other) · Study description expanded, about 10 words · 1 morev2 Show 4 more changesShow less
    • Completion date: Jul 2019 to Jul 2021
    • Interventions: Basiliximab (Drug), Mycophenolate Mofetil (Drug), Tacrolimus (Drug) to Mesenchymal Stromal Stem Cells (MSCs) Infusion (Biological), Normal Saline (Placebo) Infusion (Other)
    • Study description expanded, about 10 words
    • Collaborators: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov