Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081913
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2004-04-26
Brief Title:
Stem Cell Study for Patients With Heart Disease
Sponsor:
Losordo Douglas MD
Organization:
Losordo Douglas MD
Study Overview
Official Title:
Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 if cell therapy with your own cells autologous cells delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain andor your ability to exercise
Detailed Description:
The goal of this study is to determine the safety of various doses of autologous ones own stem cells delivered with a catheter into the regions of the heart with poor blood flow Stem cells are primitive cells produced by bone marrow that can develop into blood cells or other types of cells In addition to determining whether this new approach is safe the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating myocardial ischemia the condition where areas in the heart are lacking enough oxygen and blood flow to keep the heart muscle working well
This is a blinded randomized study to compare a certain type of stem cell called CD34-positive versus a placebo agent normal saline You will have a 31 chance of receiving your CD34-positive stem cells versus the placebo agent normal saline You will not know whether you received the CD34-positive cells or the placebo agent normal saline If you are randomized to receive placebo normal saline you will undergo all of the pre-treatment phases of this study including the stem cell mobilization phase and the apheresis procedure but rather than receiving injections of CD34-positive cells you will receive injections of the placebo agent normal saline There is some research evidence that suggests CD34-positive cells may help develop new blood vessels or improve blood flow when injected directly into the heart muscle
This is a blinded randomized study to compare a certain type of stem cell called CD34-positive versus a placebo agent normal saline You will have a 31 chance of receiving your CD34-positive stem cells versus the placebo agent normal saline You will not know whether you received the CD34-positive cells or the placebo agent normal saline If you are randomized to receive placebo normal saline you will undergo all of the pre-treatment phases of this study including the stem cell mobilization phase and the apheresis procedure but rather than receiving injections of CD34-positive cells you will receive injections of the placebo agent normal saline There is some research evidence that suggests CD34-positive cells may help develop new blood vessels or improve blood flow when injected directly into the heart muscle
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