The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
This study is ongoing, but not recruiting participants.
Sponsor:
Deborah Ascheim
Collaborator:
Information provided by (Responsible Party):
Deborah Ascheim, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01442129
First received: September 26, 2011
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Cardiomyopathy Ventricular Dysfunction |
Biological: Mesenchymal Precursor Cell Injection Biological: 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function |
Resource links provided by NLM:
Further study details as provided by Mount Sinai School of Medicine:
Primary Outcome Measures:
- Intervention related adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.
Secondary Outcome Measures:
- Functional Status and Ventricular Function [ Time Frame: 90 days ] [ Designated as safety issue: No ]The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.
| Enrollment: | 30 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MPC Intramyocardial injection
Intramyocardial injections of 25 million MPCs
|
Biological: Mesenchymal Precursor Cell Injection
Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation
Other Name: RevascorTM
|
|
Sham Comparator: Control Solution
Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
|
Biological: 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Injection of control solution during the LVAD implantation.
Other Name: Cryoprotective media
|
Detailed Description:
Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes, as well as induce development of capillaries and larger size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes, and release factors capable of paracrine signaling. If safety is established and an efficacy signal is observed in this exploratory trial, then the investigators will design a follow-up trial (stage 2) based on an adaptive design. The next trial would randomize patients to active therapy at one of two doses (25 and 75 million MPCs) versus placebo, and based on a predetermined selection criterion drop randomization to one of the dose arms as results accrue. Should this exploratory trial demonstrate safety but no signal of efficacy, then the subsequent trial would be based on a single dose of 75 million MPCs versus placebo.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 < 100,000/ul within 24 hours prior to randomization;
- Active systemic infection within 48 hours prior to randomization;
- Presence of >10% 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442129
Locations
| United States, Florida | |
| University of Florida | |
| Gainsville, Florida, United States, 32610 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | |
| Minneapolis, Minnesota, United States, 55407 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Montefiore Einstein Heart Center | |
| Bronx, New York, United States, 10467 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor Research Institute | |
| Dallas, Texas, United States, 75230 | |
| Texas Heart Institute | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Deborah Ascheim
Investigators
| Study Chair: | Timothy Gardner, MD | Christiana Care Health Services |
| Study Chair: | Patrick O'Gara, MD | Brigham and Women's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Deborah Ascheim, Associate Professor, Clinical Director of Research, InCHOIR, Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01442129 History of Changes |
| Other Study ID Numbers: | GCO 08-1078-00006, U01HL088942, U01HL088942-04, 711 |
| Study First Received: | September 26, 2011 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Heart Failure Left Ventricular Assist Device Heart Transplantation |
Cardiomyopathy Destination Therapy Cell Therapy |
Additional relevant MeSH terms:
|
Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013