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NCT02091232 · ClinicalTrials.gov registry record · Phase 1
Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02091232: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT02091232 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02091232, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells. In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction. After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation. This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.
Interventions
- BIOLOGICAL T Regulatory Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-03-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02091232
The ClinicalTrials.gov registry entry for NCT02091232 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which T Regulatory Cell Infusion is the first listed.
NCT02091232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02091232 about?
NCT02091232 is a clinical study titled "Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)". This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the n...
What is the current status of trial NCT02091232?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-05. Estimated completion is 2016-03-02.
What interventions are being tested in trial NCT02091232?
The interventions under investigation include: T Regulatory Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02091232?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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