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NCT00325741 · ClinicalTrials.gov registry record · Phase 1

Allogeneic Blood Stem Cell Transplantation for Patients With Life-Threatening Systemic Lupus Erythematosus

A Phase 1 study, sponsored by Stanford University.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT00325741: Clinical Trial Phase 1 study, sponsored by Stanford University.

NCT00325741 is a Phase 1 study that was terminated before completion, run by Stanford University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00325741, a Phase 1 study, was terminated before completion, sponsored by Stanford University.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood and Marrow Transplantation (BMT) are enrolling patients with severe systemic lupus erythematosus (SLE) that is resistant to standard treatment (prednisone and cyclophosphamide \[Cytoxan\]) into a new study to determine if they can be successfully treated with a blood stem cell transplantation obtained from an appropriate donor. Donors will be human leukocyte antigen (HLA)-matched healthy brothers or sisters. For patients without sibling HLA-matches, a search for donors will be initiated through the US and International Donor Registries. Eligible patients must be at least 18 years old and have SLE with progressive kidney, lung, heart, or central nervous system disease that has not responded to standard therapy. Patients will be treated for two weeks to prepare them for the infusion of blood stem cells that are obtained from their HLA-matched donor. Patients will initially be treated with immunosuppressive drugs, which will be gradually withdrawn at approximately 6 months after transplantation. The goal of this study is to replace the abnormal immune cells of the SLE affected patient that causes the disease with normal immune cells that are generated from the transplant blood stem cells from the healthy donor.

Interventions

  • DRUG Hematopoietic Cell Transplantation

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2004-06
Est. Completion 2015-10
Phase Phase 1
Stanford University

1,744 total trials

Why NCT00325741 stopped before completion

NCT00325741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Hematopoietic Cell Transplantation is the first listed.

NCT00325741 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00325741 about?

NCT00325741 is a clinical study titled "Allogeneic Blood Stem Cell Transplantation for Patients With Life-Threatening Systemic Lupus Erythematosus". The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood and Marrow Transplantation (BMT) are enrolling patients with severe systemic lupus erythematosus (SLE) that is resistant to standard treatment (prednisone and cyclophosphamide \[Cytoxan\]) into a new study ...

What is the current status of trial NCT00325741?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2004-06. Estimated completion is 2015-10.

What interventions are being tested in trial NCT00325741?

The interventions under investigation include: Hematopoietic Cell Transplantation (DRUG).

Who is sponsoring clinical trial NCT00325741?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00325741's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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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Source: ClinicalTrials.gov NCT00325741, the US trial registry maintained by the National Library of Medicine. NCT00325741 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.