Status:
COMPLETED
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
Lead Sponsor:
Triple-Gene, LLC
Collaborating Sponsors:
Intrexon Corporation
Precigen, Inc
Conditions:
Heart Failure
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-rela...
Detailed Description
This is a first-in-human, phase I, open label, safety study of INXN-4001 delivered via RCSI in patients with outpatient LVAD. Twelve stable patients with implanted LVAD for mechanical support of end s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03409627
Start Date
April 9 2018
End Date
August 12 2020
Last Update
December 4 2020
Active Locations (2)
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1
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
2
The Lindner Research Center, The Christ Hospital Health Network
Cincinnati, Ohio, United States, 45219