Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-02 @ 1:52 PM
Study NCT ID:
NCT03129568
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
Sponsor:
Okayama University
Organization:
Study Overview
Official Title:
A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2021-11
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:
TICAP-DCM
Brief Summary:
A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
Detailed Description:
Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.
Study Oversight
Has Oversight DMC:
True
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?: