Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01557543 stopped before completion
NCT01557543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Cell Therapy is the first listed.
NCT01557543 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01557543's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI