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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 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00424489
The ClinicalTrials.gov registry entry for NCT00424489 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 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.
NCT00424489 reports 0 study locations.
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.
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