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NCT00424489 · ClinicalTrials.gov registry record · Phase 1
Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00424489: Clinical Trial Phase 1 study, sponsored by Northwestern University.
NCT00424489 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00424489, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
MG may be neonatal, congenital, or autoimmune. Neonatal MG arises from transplacental transfer of ACh receptor antibodies from a mother with autoimmune MG to the fetus. Neonatal MG resolves with post delivery clearance of maternal antibodies. Congenital MG results from a genetic defect in the ACh receptor. Patients with congenital MG do not have ACh receptor antibodies. Both neonatal and congenital MG are excluded from this study. Autoimmune MG, which is the most common form of MG, affects approximately 25,000 Americans. Like most autoimmune diseases, it is associated with particular HLA genotypes, has a female predominance, and environmental factors involved in breaking tolerance to the ACh receptor are unknown. Patients with refractory and severe autoimmune MG will be considered candidates for this study. The purpose of this study is to assess the toxicity/feasibility (phase I) of autologous hematopoietic stem cell transplantation for refractory myasthenia gravis.
Primary Outcome
Survival
Interventions
- DRUG Cyclophosphamide
- DRUG Mesna
- DRUG Methylprednisolone
- BIOLOGICAL Hematopoietic Stem Cell Transplantation
- DRUG ATG (rabbit)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2002-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
Why NCT00424489 stopped before completion
NCT00424489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00424489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00424489 about?
NCT00424489 is a clinical study titled "Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis". MG may be neonatal, congenital, or autoimmune. Neonatal MG arises from transplacental transfer of ACh receptor antibodies from a mother with autoimmune MG to the fetus. Neonatal MG resolves with post delivery clearance of maternal antibodies. Congenital MG results from a genetic defect in the ACh re...
What is the current status of trial NCT00424489?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2002-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00424489?
The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), Methylprednisolone (DRUG), Hematopoietic Stem Cell Transplantation (BIOLOGICAL), ATG (rabbit) (DRUG).
Who is sponsoring clinical trial NCT00424489?
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 NCT00424489's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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