Registry to Assess Safety for Subjects That Have Completed a Juventas Sponsored HF Protocol Under IND # 14203

Status unconfirmed

Conditions studied: Ischemic Heart Failure

In brief

This is an exploratory registry that will include subjects who have been randomized to receive JVS-100 treatment (at one of multiple doses) or placebo by one of a number of delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous Juventas clinical trial.

Key facts

Study ID

NCT02115568

Run by

Juventas Therapeutics, Inc.

People needed

165

Starts

2014-01-01

Expected to finish

2017-01-01

Last updated by the study team

2014-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in and completed a Juventas sponsored heart failure study under IND 14203

You may not qualify if…

• Unwillingness to sign informed consent form
• Unwillingness or inability to receive phone calls for required follow up assessments
• Subjects actively participating in another regenerative medicine trial should be discussed with sponsor prior to enrollment

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• University of Florida — Gainsville, Florida, United States
• Pepin Heart Institute — Tampa, Florida, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• University of Kentucky Gill Heart Institute — Lexington, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Summa Health System — Akron, Ohio, United States
• The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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