Novel INXN-4001 Triple Effector Plasmid in Heart Failure



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:April 9, 2018
End Date:December 2019
Contact:Ewa Jaruga-Killeen
Email:EJaruga-Killeen@dna.com
Phone:561-410-7012

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A Phase I, Open Label, Safety Study of INXN-4001 Delivered Via Retrograde Coronary Sinus Infusion in Patients With an Outpatient Left Ventricular Assist Device (LVAD)

To evaluate the safety of retrograde coronary sinus infusion of a novel triple-effector
plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study
intervention - related adverse events occurring up to 6 months post-treatment


Inclusion Criteria:

- Male and female adult patients with a stable LVAD implanted for end-stage heart
failure

- Must be managed in an outpatient setting and on stable medication regimen

Exclusion Criteria:

- Women who are pregnant or nursing

- Patients who have been on another clinical trial for heart failure in the last 90
days, or have received any stem cell or gene therapy within the previous year.

- Patient is not able to complete a Six Minute Walk Test or unable to tolerate an LVAD
wean in the past 3 months

- Patient has an active infection requiring systemic antibiotics or an autoimmune
disease requiring systemic immunosuppressants

- Patient has a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy,
systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke

- Patient has had a myocardial infarction related to ischemia within the past 30 days

- Patient has had certain prior surgeries such as organ transplant, cardiac
transplantation, left ventricle reduction surgery, or cardiomyoplasty

- Patient has infectious disease, such as hepatitis B or C, or human immunodeficiency
virus (HIV)

- Patient has a history of cancer within the past 3 years
We found this trial at
2
sites
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mi
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Tucson, AZ
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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mi
from
Bronx, NY
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