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NCT03478215 · ClinicalTrials.gov registry record · Phase 2
Mesenchymal Stromal Cells in Living Donor Kidney Transplantation
A Phase 2 study of Renal Transplantation and Mesenchymal Stem Cells, sponsored by The Methodist Hospital Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03478215: Active Phase 2 study of Renal Transplantation and Mesenchymal Stem Cells, sponsored by The Methodist Hospital Research Institute.
NCT03478215 is a Phase 2 study of Renal Transplantation and Mesenchymal Stem Cells that is active but no longer recruiting, run by The Methodist Hospital Research Institute. The registered enrollment target is 24 participants, below the 48-participant average among 7 other Renal Transplantation trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478215, a Phase 2 study of Renal Transplantation and Mesenchymal Stem Cells, is active but no longer recruiting, sponsored by The Methodist Hospital Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Infusional toxicity will be assessed as the occurrence of either 1) two or more participants having deep vein thrombosis (Grade 2 thrombotic event); 2) any participant having evidence of the first-pass phenomenon of cells trapping in the lung as evidenced by (a) shortness of breath at rest, (b) requiring ventilator support, or (c) pulmonary edema with hypoxia requiring support; or 3) Grade 4 hypertension or hypotension; or 4) acute myocardial infarction; or 5) new onset congestive heart failure;
Conditions Studied
Interventions
- BIOLOGICAL Mesenchymal Stromal Stem Cells (MSCs) Infusion
- OTHER Normal Saline (Placebo) Infusion
Study Locations (1)
Texas
- Houston Methodist Hospital System - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT03478215 still lists
NCT03478215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 48-participant average among 7 other Renal Transplantation trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with Renal Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Mesenchymal Stromal Stem Cells (MSCs) Infusion is the first listed.
NCT03478215 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03478215 about?
NCT03478215 is a clinical study titled "Mesenchymal Stromal Cells in Living Donor Kidney Transplantation". 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) d...
What is the current status of trial NCT03478215?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-12. Estimated completion is 2026-12.
What conditions does trial NCT03478215 study?
This clinical trial studies the following conditions: Renal Transplantation, Mesenchymal Stem Cells.
What interventions are being tested in trial NCT03478215?
The interventions under investigation include: Mesenchymal Stromal Stem Cells (MSCs) Infusion (BIOLOGICAL), Normal Saline (Placebo) Infusion (OTHER).
Who is sponsoring clinical trial NCT03478215?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03478215 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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