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

Juventas Therapeutics

Status: Unknown

Conditions: Ischemic Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02115568

JTCS-005

Details and patient eligibility

About

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.

Full description

This Registry will assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure and track any newly diagnosed malignancies. The logistics of the study are as follows: to be eligible, subjects must have actively participated in a Juventas sponsored trial under IND 14203. After consent, subjects will be followed for up to three years post receipt of investigational product during which time they will receive phone calls (every 3 months) from the study site asking about their health. Questions will be aimed at cardiovascular related events including:

• Hospitalizations
• ER Visits
• Unscheduled visits with Cardiologist
• Newly diagnosed malignancies Serious Adverse Events (SAEs) will not be reported in this study; however, data pertaining to such events will be captured (i.e. date of admission and diagnosis.). Data will be captured on paper CRFs, collected by Juventas (or their designee) and will be entered into a clinical database for analysis.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

165 participants in 1 patient group

Long-term safety follow-up

Description:

To be eligible, subjects must have actively participated in a Juventas (JVS-100) sponsored trial under IND 14203.