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Heart Failure - Healing Genes
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Heart Failure

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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)


Phase 1

DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. A single infusion into a primary vein of the heart to deliver the trial therapy
  3. After observation, the patient will be discharged and keep in contact to report any adverse reactions.
  4. A wearable biosensor will be worn for 12 months, and some additional visits may be required.

LOCATIONS AND CONTACTS:

The study site is at the University of Arizona Sarver Heart Center (Map) and Montefiore Medical Center in New York (Map).

Contacts:

Ewa Jaruga-Killeen | [email protected] | 561-410-7012

 

SPONSOR INFORMATION:

Xogenex, LLC & Precigen, LLC

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03409627

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