Ignite Creation Date:
2024-05-06 @ 8:07 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02673164
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2016-02-01
Brief Title:
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease
Sponsor:
JKastrup
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCIENCE
Brief 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 21 randomization with either CSCC_ASC or placebo saline
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 21 randomization with either CSCC_ASC or placebo saline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None