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NCT00282438 · ClinicalTrials.gov registry record · Phase 1
Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00282438: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT00282438 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00282438, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Sarcoidosis is a disease believed to be due to immune cells, cells which normally protect the body, but are now attacking lungs, heart, nerves, or other organs or systems within the body. As a result, the affected organs or systems fail to work properly causing difficulty breathing; heart failure; inability of the nerves to respond properly causing numbing, tingling, pain, and progressive muscle weakness; or other symptoms depending on the organ or body system involved. 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 the previously collected blood stem cells will stop the progression of sarcoidosis. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body.
Primary Outcome
Daily assessment will be made with regards to toxicity by one of the protocol investigators.National Cancer Institute Common Toxicity Criteria will be used to grade all non-hematologic toxicities. Toxicity grades as follows: 1 = Mild; 2 = Moderate; 3 = Severe and undesirable; 4 = life threatening or disabling ; 5 = Death
Interventions
- BIOLOGICAL Autologous hematopoietic stem cell transplantation
- BIOLOGICAL Allogeneic stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2003-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
Why NCT00282438 stopped before completion
NCT00282438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Autologous hematopoietic stem cell transplantation is the first listed.
NCT00282438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00282438 about?
NCT00282438 is a clinical study titled "Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis". Sarcoidosis is a disease believed to be due to immune cells, cells which normally protect the body, but are now attacking lungs, heart, nerves, or other organs or systems within the body. As a result, the affected organs or systems fail to work properly causing difficulty breathing; heart failure; i...
What is the current status of trial NCT00282438?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2003-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00282438?
The interventions under investigation include: Autologous hematopoietic stem cell transplantation (BIOLOGICAL), Allogeneic stem cell transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00282438?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00282438's enrollment target sits among peer trials
2 2000th 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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