Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT01458405
Status:
TERMINATED
Last Update Posted:
2024-04-09
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
Sponsor:
Capricor Inc.
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
On February 28, 2019, Capricor ceased ongoing follow-up activities and terminated the ALLSTAR trial to focus resourcing on its active CAP-1002 program, HOPE-2.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLSTAR
Brief Summary:
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RC3HL103356-01 | NIH | None | https://reporter.nih.gov/quic… | View |