NCT01496209

REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.

Conditions

• Ischemic Cardiomyopathy
• Chronic Ischemic Cardiomyopathy

Interventions

Type	Name	Description
BIOLOGICAL	Endomyocardial injections of allogeneic Human CSps	NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
BIOLOGICAL	Endomyocardial injections of vehicle only.	NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2011-12-21
• Last updated: 2014-02-12

Locations

1 site across 1 country: United States