NCT02673164

Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease

Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: JKastrup · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre\_adipose derived stem cells (CSCC\_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.

Detailed description

The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre\_adipose derived stem cells (CSCC\_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure. The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC\_ASCs in patients with reduced left ventricular EF (≤45%) and heart failure in a double-blind placebo-controlled design. A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC\_ASC or placebo (saline).

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	CSCC_ASC	The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-02-03
• Last updated: 2021-01-19

Locations

1 site across 1 country: Denmark