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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02362646
• Date of registration: 09/02/2015
• Prospective Registration: Yes
• Primary sponsor: Annetine Gelijns
• Public title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
• Scientific title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
• Date of first enrolment: July 2015
• Target sample size: 159
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02362646
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Richard Weisel, MD
• Affiliation: Toronto General Hospital

• Name: Patrick O'Gara, MD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Ventricular Dysfunction

Cardiomyopathy

Intervention(s)

Biological: MPC Intramyocardial Injection

Drug: Control Solution

Primary Outcome(s)

Number of Temporary Weans From LVAD Support Tolerated [Time Frame: up to 6 months]

Number of Participants With Adverse Events [Time Frame: up to 6 months]

Secondary Outcome(s)

MCG Complex Figures [Time Frame: 3 months and 12 months]

Digit Span [Time Frame: 3 months and 12 months]

Change in Quality of Life (QoL) [Time Frame: 6 months and 12 months]

Hospital Costs [Time Frame: up to 12 months]

Length of Stay [Time Frame: up to 12 months]

Hospitalizations [Time Frame: up to 12 months]

Controlled Oral Word Association [Time Frame: 3 months and 12 months]

Digit Symbol Substitution Test [Time Frame: 3 months and 12 months]

Functional Status [Time Frame: up to 12 months]

Histopathological Assessments of Myocardial Tissue [Time Frame: up to 12 months]

Hopkins Verbal Learning Test [Time Frame: 3 months and 12 months]

Overall Survival [Time Frame: up to 12 months]

Physiologic Assessments [Time Frame: up to 12 months]

Trailmaking Tests A and B [Time Frame: 3 months and 12 months]

Secondary ID(s)

2U01HL088942-07

GCO 08-1078-0008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Results

• Results available: Yes
• Date Posted: 26/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02362646