Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349271
Status:
TERMINATED
Last Update Posted:
2017-03-13
First Post:
2006-07-05
Brief Title:
Cell Therapy in Chagas Cardiomyopathy
Sponsor:
Ministry of Health Brazil
Organization:
Ministry of Health Brazil
Study Overview
Official Title:
Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change the sample size due to smaller variance than expected
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 determine effect of cell therapy in patients with severe dilated cardiomyopathy
Detailed Description:
This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group under optimized therapy for dilated cardiomyopathy Secondary endpoints will evaluate the alteration in NYHA functional class mortality rate physical capacity by ergoespirometry life quality Minnesota questionnaire and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group under optimized therapy for dilated cardiomyopathy Secondary endpoints will evaluate the alteration in NYHA functional class mortality rate physical capacity by ergoespirometry life quality Minnesota questionnaire and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant
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