Novel INXN-4001 Triple Effector Plasmid in Heart Failure
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)
Doctors at the University of Arizona Sarver Heart Center and Montefiore Medical Center in New York are seeking patients with a stable Left Ventricular Assist Device (LVAD) for end-stage heart failure. These participants may be eligible to trial a genetic therapy intended to rebuild damaged heart muscle cells.
The treatment involves infusion to the coronary sinus of a loop of customized DNA encoding instructions for making 3 key heart muscle proteins. Participants will be assigned one of 2 doses, then followed for 12 months via a wearable monitor, questionnaire, and overall health assessments.
- Be 18 years of age or older
- Have a stable LVAD and diagnosis of end-stage heart failure but managed in an outpatient setting
- Not be pregnant or breastfeeding
- Not have a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy, systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility and safety of the patient to participate.
- A single infusion into a primary vein of the heart to deliver the trial therapy
- After observation, the patient will be discharged and keep in contact to report any adverse reactions.
- A wearable biosensor will be worn for 12 months, and some additional visits may be required.
LOCATIONS AND CONTACTS:
Ewa Jaruga-Killeen | [email protected] | 561-410-7012
Xogenex, LLC & Precigen, LLC
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