Cleveland, Ohio 44195

  • Ventricular Dysfunction

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.


Study summary:

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; 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.


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 < 100,000/ul within 24 hours prior to randomization - Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis - Presence of >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


Study is Available At:


Original ID:

GCO 08-1078-0008


NCT ID:

NCT02362646


Secondary ID:

2U01HL088942-07


Study Acronym:


Brief Title:

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients


Official Title:

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Icahn School of Medicine at Mount Sinai


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

159


Enrollment Type:

Actual


Overall Contact Information

Official Name:Patrick O'Gara, MD
Study Chair
Brigham and Women's Hospital

Study Dates

Start Date:July 2015
Completion Date:August 23, 2019
Completion Type:Actual
Primary Completion Date:August 10, 2018
Primary Completion Type:Actual
Verification Date:November 2019
Last Changed Date:November 7, 2019
First Received Date:February 9, 2015
First Results Date:November 7, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Functional Status
Time Frame:up to 12 months
Safety Issues:False
Description:functional status, defined by the number of temporary weans from LVAD support tolerated
Outcome Type:Secondary Outcome
Measure:Hospital Costs
Time Frame:up to 12 months
Safety Issues:False
Description:Hospital resource use
Outcome Type:Secondary Outcome
Measure:Hospitalizations
Time Frame:up to 12 months
Safety Issues:False
Description:Frequency and cause of readmissions
Outcome Type:Secondary Outcome
Measure:Length of Stay
Time Frame:up to 12 months
Safety Issues:False
Description:Length of stay of index hospitalization
Outcome Type:Secondary Outcome
Measure:Controlled Oral Word Association
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed using the Controlled Oral Word Association. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:Digit Symbol Substitution Test
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed using the Digit Symbol Substitution Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:Digit Span
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:MCG Complex Figures
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:Trailmaking Tests A and B
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed using Trailmaking Tests A and B. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:Hopkins Verbal Learning Test
Time Frame:3 months and 12 months
Safety Issues:False
Description:Cognitive performance will be assessed Hopkins Verbal Learning Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.
Outcome Type:Secondary Outcome
Measure:Change in Quality of Life (QoL)
Time Frame:6 months and 12 months
Safety Issues:False
Description:Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used tool in heart failure populations, and the Short Form 12 (SF12), a widely used overall health status measure.
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:up to 12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Histopathological Assessments of Myocardial Tissue
Time Frame:up to 12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Physiologic Assessments
Time Frame:up to 12 months
Safety Issues:False
Description:Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6-Minute Walk Test (MWT) while weaned from LVAD support (for patients who tolerate wean from LVAD sup
Outcome Type:Primary Outcome
Measure:Number of Participants With Adverse Events
Time Frame:up to 6 months
Safety Issues:False
Description:Safety as assessed by number of study intervention-related adverse events
Outcome Type:Primary Outcome
Measure:Number of Temporary Weans From LVAD Support Tolerated
Time Frame:up to 6 months
Safety Issues:False
Description:functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of wor

Study Interventions

Intervention Type:Biological
Name:MPC Intramyocardial Injection
Description:Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation
Arm Name:MPC Intramyocardial Injection
Other Name:Mesenchymal Precursor Cell Injection
Intervention Type:Drug
Name:Control Solution
Arm Name:Control Solution
Other Name:50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/

Study Arms

Study Arm Type:Experimental
Arm Name:MPC Intramyocardial Injection
Description:Intramyocardial injections of 150 million MPCs
Study Arm Type:Sham Comparator
Arm Name:Control Solution
Description:Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Annetine Gelijns
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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