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NCT00342134 · ClinicalTrials.gov registry record · Phase 2
Immunological Mechanisms of Hematopoietic Stem Cell Transplantation in Multiple Sclerosis
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00342134 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 34 participants.
The verdict
NCT00342134, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis (MS). The molecular pathogenesis of multiple sclerosis is poorly understood although T-cell mediated immune destruction of myelin is thought to be an important element. We hypothesize, and the results of previous studies suggest, that radical immuno-ablation characterized by a profound T cell depletion can arrest the progression of disease. Patients with MS with poor prognosis based on the rate of progression and refractoriness to approved treatments (interferon-beta, glatiramer acetate) will be enrolled in clinical trials at the collaborating institution (NWU-Dr. R. Burt; Dr. D Kerr, JHU) and will receive either immune ablation with cyclophosphamide and the antibody Campath-1 followed by reconstitution with autologous peripheral blood stem cells, a procedure similar to autologous bone marrow transplantation, or high-dose cyclophosphamide treatment without stem cell rescue. While the overall treatment-related mortality worldwide is approximately 10%, the collaborating institution and investigators have an outstanding safety record in performing the procedure with no fatal adverse events after having transplanted more than 30 transplants with a previously more aggressive regimen than the one that is in use now. The underlying rationale for this treatment is that immuno-ablation could eliminate myelin-reactive T cells which, in disease-susceptible individuals, may have been activated by previous exposure to environmental agents or other acquired mechanisms of immune dysregulation. In the proposed study we plan to address whether HSCT or immunoablation without stem cell rescue act beneficially in MS via the eradication of myelin-reactive T cells and reconstitution of a functional and non-autoimmune immune repertoire. To achieve this goal, we will compare peripheral blood T cell reactivit
Interventions
- PROCEDURE Stem Cell Transplanataion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2002-05-01 |
| Est. Completion | 2011-05-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00342134
The ClinicalTrials.gov registry entry for NCT00342134 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stem Cell Transplanataion is the first listed.
NCT00342134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00342134 about?
NCT00342134 is a clinical study titled "Immunological Mechanisms of Hematopoietic Stem Cell Transplantation in Multiple Sclerosis". Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis (MS). The molecular pathogenesis of multiple sclerosis is poorly understood although T-cell mediated immune destruct...
What is the current status of trial NCT00342134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2002-05-01. Estimated completion is 2011-05-04.
What interventions are being tested in trial NCT00342134?
The interventions under investigation include: Stem Cell Transplanataion (PROCEDURE).
Who is sponsoring clinical trial NCT00342134?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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