Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128258
Status:
TERMINATED
Last Update Posted:
2018-01-19
First Post:
2005-08-08
Brief Title:
AutologousAllogeneic Progenitor Stem Cell Therapy for Congestive Heart Failure
Sponsor:
Amit Patel N MD
Organization:
Amit Patel N MD
Study Overview
Official Title:
Phase 1 Study AutologousAllogeneic Bone Marrow Progenitor Cell Treatment for Heart Failure
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study no longer at pittsburgh
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being performed to find out more information about the safety and effectiveness of injecting bone marrow progenitor cells BMPCs from ones own hip bone into ones heart muscle The BMPCs are the cells from which the different types of blood and other cells grow
In patients with heart failure the heart muscle does not pump well Over a period of years this continues to get worse until the patient dies of heart failure The investigators are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function however there has been no evidence from actual studies of the cells of the patients hearts to show how this process works It is the investigators plan to inject an eligible participants heart with cells that are from ones own bone marrow during an operation to receive a ventricular assist device VAD or partial artificial heart and then to study the function of the heart while awaiting a heart transplant The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes changes too small to be seen by the unaided eye but large enough to be studied under a microscope at the site where the cells are injected Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study There will also be no delay in receiving a VAD operation while waiting to participate in this study This Phase I study has been cleared by the Food and Drug Administration FDA to enroll and treat patients The Center for Biologics Evaluation and Research Investigational New Drug number IND BB is 12304 A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects
In patients with heart failure the heart muscle does not pump well Over a period of years this continues to get worse until the patient dies of heart failure The investigators are trying to find out if the injection of these BMPCs can make a change in the functioning of these areas of the heart muscle Data from studies around the world have suggested that when patients with heart failure receive these cells by direct injection into their hearts they show signs of recovered heart function however there has been no evidence from actual studies of the cells of the patients hearts to show how this process works It is the investigators plan to inject an eligible participants heart with cells that are from ones own bone marrow during an operation to receive a ventricular assist device VAD or partial artificial heart and then to study the function of the heart while awaiting a heart transplant The investigators will then examine the heart after it has been removed as part of the regular heart transplant operation for any microscopic changes changes too small to be seen by the unaided eye but large enough to be studied under a microscope at the site where the cells are injected Participants will have no change in the chances of receiving a heart transplant by agreeing to participate in this study There will also be no delay in receiving a VAD operation while waiting to participate in this study This Phase I study has been cleared by the Food and Drug Administration FDA to enroll and treat patients The Center for Biologics Evaluation and Research Investigational New Drug number IND BB is 12304 A Phase I trial is a research study using techniques or products in the first-stage or for the first time in human subjects
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