Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925608
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-06
First Post:
2023-06-22
Brief Title:
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells CardiALLO
Sponsor:
BioCardia Inc
Organization:
BioCardia Inc
Study Overview
Official Title:
Phase III Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells in Patients With Post-Myocardial Infarction Heart Failure
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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:
None
Brief Summary:
This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from the NK1R Mesenchymal stem cells as a therapy for chronic ischemic left ventricular dysfunction delivered using the investigational Helix transendocardial delivery catheter
Detailed Description:
Chronic heart failure is in need of new therapies Over the past few years cardiovascular regenerative medicine using bone marrow-derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure At present several types of adult bone marrow derived stem cells hold great promise to treat heart failure Allogenic culture-expanded bone marrow-derived human mesenchymal stem cells MSC are the subject of the current study as having potential to provide a safe and effective treatment for patients with ischemic heart failure Mesenchymal stem cells are multipotent stromal cells that can differentiate into a variety of cell types including osteoblasts bone cells chondrocytes cartilage cells myocytes muscle cells and adipocytes fat cells which give rise to marrow adipose tissue The CardiALLO cell therapy is an allogenic bone marrow-derived NK1R selected and culture-expanded mesenchymal stem cells that will be delivered intramyocardially using the investigational Helix delivery catheter The purpose of this study is to determine the safety optimal dose and efficacy of CardiALLO cell therapy system in patients with post-myocardial infarction heart failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None