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NCT01557543 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01557543 is a Phase 1 study that was terminated before completion, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 24 participants.
The verdict
NCT01557543, a Phase 1 study, was terminated before completion, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: \- Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage. Objectives: \- To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. Eligibility: \- Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. * Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery. * During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures. * After the surgery, participants will be monitored for complications from the stromal stem cells. * Participants will have heart function tests to see if the stromal stem cell treatments were effective....
Interventions
- OTHER Cell Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-02-29 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01557543
The ClinicalTrials.gov registry entry for NCT01557543 describes a study currently listed as terminated, 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 National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cell Therapy is the first listed.
NCT01557543 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01557543 about?
NCT01557543 is a clinical study titled "Stem Cell Injection to Treat Heart Damage During Open Heart Surgery". Background: \- Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle ...
What is the current status of trial NCT01557543?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-02-29. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT01557543?
The interventions under investigation include: Cell Therapy (OTHER).
Who is sponsoring clinical trial NCT01557543?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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