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NCT00058578 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant to Treat Patients With Systemic Sclerosis
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00058578 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 24 participants.
The verdict
NCT00058578, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease. Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. In this study, we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem cells, select specific cells, and store them. We will then give high dose chemotherapy that will destroy the patients immune system. We will then give back the selected stem cells we collected. We believe that these selected stem cells may be able to "re-create" the immune system without the portion that causes Systemic Sclerosis. The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis. We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis. We hope that this treatment will help to relieve the symptoms patients are experiencing, although we do not know if it will.
Interventions
- DRUG Cyclophosphamide
- DRUG Mesna
- DRUG G-CSF
- PROCEDURE Leukopheresis
- PROCEDURE Total Body Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 1999-06 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058578
The ClinicalTrials.gov registry entry for NCT00058578 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00058578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00058578 about?
NCT00058578 is a clinical study titled "Stem Cell Transplant to Treat Patients With Systemic Sclerosis". Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease. Stem cells are created in the bone marrow. They mature into different types of blood ce...
What is the current status of trial NCT00058578?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 1999-06. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00058578?
The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), G-CSF (DRUG), Leukopheresis (PROCEDURE), Total Body Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT00058578?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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