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NCT00278564 · ClinicalTrials.gov registry record · Phase 1

Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases

A Phase 1 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 1
Development phase
7
Enrollment target

NCT00278564 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 7 participants.

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The verdict

NCT00278564, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body. As a result, the affected muscles and organs fail to work properly causing weakness, difficulty swallowing, skin rash, respiratory problems, heart problems, joint stiffness, soft tissue calcification and vasculitis (blood circulation problems). The likelihood of progression of this disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing this disease), followed by return of previously collected blood stem cells will stop the progression of myositis.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Mesna
  • DRUG Methylprednisolone
  • BIOLOGICAL Hematopoietic stem cell transplantation
  • DRUG ATG(rabbit)

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2005-09
Est. Completion 2016-07
Phase Phase 1

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT00278564

The ClinicalTrials.gov registry entry for NCT00278564 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT00278564 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00278564 about?

NCT00278564 is a clinical study titled "Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases". Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body. As a result, the affected muscles and organs fail to work properly causing weakness, difficulty swallowing, skin rash, respiratory ...

What is the current status of trial NCT00278564?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2005-09. Estimated completion is 2016-07.

What interventions are being tested in trial NCT00278564?

The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), Methylprednisolone (DRUG), Hematopoietic stem cell transplantation (BIOLOGICAL), ATG(rabbit) (DRUG).

Who is sponsoring clinical trial NCT00278564?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.