Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300053
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2006-03-06
Brief Title:
ACT34-CMI -- Adult Autologous CD34 Cells
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
A DB Randomized Placebo-controlled Study of the Tolerability Efficacy Safety and Dose Range of Intramyocardial CLBS14 for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia ACT34-CMI
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia
Detailed Description:
This is a double-blind prospective randomized placebo-controlled trial to determine the tolerability efficacy safety and dose range of intramyocardial injections of adult autologous CD34 cells mobilized with granulocyte colony stimulating factor G-CSF for the reduction of angina episodes in patients with refractory chronic myocardial ischemia
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