Phase 2
Completed N=30
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
Source: ClinicalTrials.gov NCT01442129 ↗Enrolled (actual)
30
Serious AEs
93.3%
Results posted
Oct 2014
Primary outcomePrimary: Intervention Related Adverse Events — 0; 0 events
Summary
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Related Adverse Events |
0; 0 | — |
| SECONDARY Functional Status and Ventricular Function |
10; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation;
- Age 18 years or older;
- If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure;
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening;
- Admitted to the clinical center at the time of randomization;
- Clinical indication and accepted candidate for implantation of an FDA approved implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.
Exclusion Criteria
- Planned percutaneous LVAD implantation;
- Anticipated requirement for biventricular mechanical support;
- Cardiothoracic surgery within 30 days prior to randomization;
- Myocardial infarction within 30 days prior to randomization;
- Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty;
- Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism);
- Stroke within 30 days prior to randomization;
- Platelet count 10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
- A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products;
- History of cancer prior to screening (excluding basal cell carcinoma);
- Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
- Received investigational intervention within 30 days prior to randomization;
- Treatment and/or an incompleted follow-up treatment of any investigational cell based therapy within 6 months prior to randomization;
- Active participation in other research therapy for cardiovascular repair/regeneration;
- Prior recipient of stem precursor cell therapy for cardiac repair;
- Pregnant or breastfeeding at time of randomization.
Data sourced from ClinicalTrials.gov (NCT01442129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.