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NCT00319657 · ClinicalTrials.gov registry record · Phase 1
Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs
A Phase 1 study of Immune Tolerance, sponsored by Stanford University.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00319657: Active Phase 1 study of Immune Tolerance, sponsored by Stanford University.
NCT00319657 is a Phase 1 study of Immune Tolerance that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319657, a Phase 1 study of Immune Tolerance, is active but no longer recruiting, sponsored by Stanford University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone Marrow Transplantation are enrolling patients into a research study to determine if blood stem cells injected after kidney transplantation, in combination with lymphoid irradiation ,will change the immune system such that immunosuppressive drugs can be completely withdrawn. Patients must have a healthy, completely human leukocyte antigen (HLA)-matched brother or sister as the organ and stem cell donor. One to two months before kidney transplant surgery, blood stem cells will be removed from the donor and the cells will be frozen. After transplant surgery, the recipient will receive radiation and anti-T cell antibody treatments for two weeks to prepare for injection of the stem cells. The stem cells will be injected at the end of the two-week treatment. If the stem cells persist in the recipient, immunosuppressive drugs will be gradually reduced until they are withdrawn completely at least six months after transplantation. Patients will be followed in the Stanford clinics for transplant patients. Patients who live outside of the San Francisco Bay Area must remain near Stanford for six weeks after transplant surgery.
Conditions Studied
Interventions
- BIOLOGICAL Hematopoietic cell transplantation
- RADIATION Total lymphoid irradiation
Study Locations (1)
California
- Stanford University, School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-07 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT00319657 still lists
NCT00319657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Immune Tolerance appearing as the primary indexed condition, and to 2 interventions - of which Hematopoietic cell transplantation is the first listed.
NCT00319657 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00319657 about?
NCT00319657 is a clinical study titled "Kidney and Blood Stem Cell Transplantation That Eliminates Requirement for Immunosuppressive Drugs". The Stanford Medical Center Program in Multi-Organ Transplantation and the Division of Bone Marrow Transplantation are enrolling patients into a research study to determine if blood stem cells injected after kidney transplantation, in combination with lymphoid irradiation ,will change the immune sys...
What is the current status of trial NCT00319657?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2004-07. Estimated completion is 2026-07.
What conditions does trial NCT00319657 study?
This clinical trial studies the following conditions: Immune Tolerance.
What interventions are being tested in trial NCT00319657?
The interventions under investigation include: Hematopoietic cell transplantation (BIOLOGICAL), Total lymphoid irradiation (RADIATION).
Who is sponsoring clinical trial NCT00319657?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00319657 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Immune Tolerance
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00319657's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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