Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00545610
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2007-10-16
Brief Title:
ACT34-CMI -- Adult Autologous CD34 Stem Cells Follow-Up Study
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
A 12-Month Follow-Up Study to Protocol 24779 A Double-blind Prospective Randomized Placebo-controlled Study to Determine the Tolerability Efficacy Safety and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34 Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia ACT34-CMI
Status:
COMPLETED
Status Verified Date:
2018-11
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:
None
Brief Summary:
The purpose of this 12-month observational follow-up study is to collect additional data by telephone contact with which to assess the efficacy safety and effects of intramyocardial injections of adult autologous CD34 cells on quality of life QoL in subjects with chronic refractory myocardial ischemia No treatments will be administered during this study However the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study 24779 so as to provide a total of 24 months of blinded data
Detailed Description:
None
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