NCT03092284

Allogeneic Stem Cell Therapy in Heart Failure

Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure: A Phase II Danish Multicentre Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: JKastrup · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC\_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC\_ASC treatment.

Detailed description

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 Ejection Fraction (EF) (≤45%) and heart failure in a double-blind placebo-controlled design. A total of 81 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC\_ASC or placebo (saline). The primary endpoint is change in left ventricle end-systolic volume (LVESV) at 6 months follow-up.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)	Direct intramyocardial injection of CSCC\_ASC
BIOLOGICAL	Placebo	Saline

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-07-01
• Completion: 2022-07-01
• First posted: 2017-03-27
• Last updated: 2022-09-06

Locations

1 site across 1 country: Denmark