Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340048
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-01-15
Brief Title:
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
Sponsor:
Help Therapeutics
Organization:
Help Therapeutics
Study Overview
Official Title:
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The purpose of this clinical study is to evaluate the feasibility safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes HiCM-188 during coronary artery bypass grafting CABG surgery in patients with severe chronic ischemic heart failure
Detailed Description:
This is a single center open-label three-group dose-escalation phase I study followed by dose-extension phase IIa study in up to 36 severe ischemic heart failure patients It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12 All the subjects need take immunosuppressant after transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None