Phase 2
N=159
Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Heart Failure · Cardiomyopathy · Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02362646 ↗Enrolled (actual)
159
Serious AEs
81.1%
Results posted
Nov 2019
Primary outcome: Primary: Number of Temporary Weans From LVAD Support Tolerated — 0.61; 0.58 number of weans
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MPC Intramyocardial Injection (Biological); Control Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Annetine Gelijns
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Temporary Weans From LVAD Support Tolerated |
0.61; 0.58 | — |
| PRIMARY Number of Participants With Adverse Events |
88; 44; 33; 12 | — |
| SECONDARY Physiologic Assessments |
— | — |
| SECONDARY Histopathological Assessments of Myocardial Tissue |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Change in Quality of Life (QoL) |
— | — |
| SECONDARY Hopkins Verbal Learning Test |
— | — |
| SECONDARY Trailmaking Tests A and B |
— | — |
| SECONDARY MCG Complex Figures |
— | — |
| SECONDARY Digit Span |
— | — |
| SECONDARY Digit Symbol Substitution Test |
— | — |
| SECONDARY Controlled Oral Word Association |
— | — |
| SECONDARY Length of Stay |
— | — |
| SECONDARY Hospitalizations |
— | — |
| SECONDARY Hospital Costs |
— | — |
| SECONDARY Functional Status |
— | — |
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.
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 (US sites only) or Health Canada-approved (Canadian sites only) 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
- Concomitant arrhythmia ablation at time of LVAD implantation
-- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation
- Cardiothoracic surgery within 30 days prior to randomization
- Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection 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-HLA antibody titers with known specificity to MPC donor HLA antigens
- A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
- History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
- Presence of human immunodeficiency virus (HIV)
- Received investigational intervention within 30 days prior to randomization
- Treatment and/or an incomplete 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.
- History of known or suspected hypercoagulable state in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT02362646). 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.