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NCT00893360 · ClinicalTrials.gov registry record · Phase 1
CArdiosphere-Derived aUtologous Stem CElls to Reverse ventricUlar dySfunction
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00893360 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 31 participants.
The verdict
NCT00893360, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether giving cardiosphere-derived stem cells (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the heart. Giving a patient their own CDCs is an investigational procedure that has been approved by the Food and Drug Administration for this study. In addition to determining whether this treatment is safe, the study will also examine whether it can decrease the amount of heart muscle damage and/or improve heart function after a heart attack. The amount of heart muscle damage and the function of the heart directly affects prognosis (the predicted course of the disease), and the development of heart failure and other complications some patients experience after a heart attack. By way of background, scientists and physicians believed, until just a few years ago, that heart muscle damaged after a heart attack could not be replaced. Recently, however, scientists discovered that new heart muscle can form, or be regenerated, and that this process can be enhanced (or increased) by the administration of large numbers of certain cells isolated from the heart or bone marrow. These cells can be stem cells, or cells derived from stem cells, and they may achieve their benefit by forming new heart muscle cells, becoming heart muscle cells themselves, or releasing substances which increase the ability of already existing stem cells to form new heart muscle. All of the studies conducted so far have been experimental and no cell type is approved for routine clinical care of patients with heart disease. However, studies involving bone marrow stem cells do indicate some small improvement in heart function and one large study demonstrated a decrease in clinical events in the group which received bone marrow cells. Investigators of this study decided to study CDCs because they come from a person's own body, and therefore
Interventions
- BIOLOGICAL Autologous stem cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00893360
The ClinicalTrials.gov registry entry for NCT00893360 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Autologous stem cell infusion is the first listed.
NCT00893360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00893360 about?
NCT00893360 is a clinical study titled "CArdiosphere-Derived aUtologous Stem CElls to Reverse ventricUlar dySfunction". The purpose of this study is to determine whether giving cardiosphere-derived stem cells (CDCs) to patients with decreased heart function and/or a large amount of damaged muscle after a heart attack is safe. CDCs are cells grown from small biopsy samples taken from the heart. Giving a patient their ...
What is the current status of trial NCT00893360?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00893360?
The interventions under investigation include: Autologous stem cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT00893360?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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