Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00747708
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2008-09-04
Brief Title:
Bone Marrow Derived Adult Stem Cells for Chronic Heart Failure
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
Randomised Control Trial to Compare the Effects of G-CSF and Autologous Bone Marrow Progenitor Cells Infusion on the Quality of Life and Left Ventricular Function in Patients With Heart Failure Secondary to Ischaemic Heart Disease
Status:
COMPLETED
Status Verified Date:
2013-10
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:
REGEN-IHD
Brief Summary:
The purpose of this study is to determine whether adult bone marrow derived stemprogenitor cells improve cardiac function and symptoms in patients with heart failure and to establish the optimal method of delivery of these cells
Study hypotheses
Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34 positive cell counts
Cardiac function and symptoms will improve in patients in whom the peripheral CD34 counts increase in response to G-CSF administration
Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
Study hypotheses
Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34 positive cell counts
Cardiac function and symptoms will improve in patients in whom the peripheral CD34 counts increase in response to G-CSF administration
Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
Detailed Description:
The study involves three arms that compare the method of autologous bone marrow cel administration in patients with chronic heart failure Each arm has a comparative group that contains either saline injection peripheral arm that injects GCSF alone or serum the two interventional arms-intracoronary and intramyocardial injection
The protocol on the advice of the ethics committee is divided into a 58 patients pilot study followed by recruitment into the intramyocardial arm 30 patients randomised 11 cells in serum vs serum alone and then recruitment into the intracoronary and peripheral arms 30 patients randomised 11 cells in serum vs serum alone in each arm
The study has been powered around the use of advanced imaging to measure within group changes in ejection fraction at 12 months as the primary end point
The protocol on the advice of the ethics committee is divided into a 58 patients pilot study followed by recruitment into the intramyocardial arm 30 patients randomised 11 cells in serum vs serum alone and then recruitment into the intracoronary and peripheral arms 30 patients randomised 11 cells in serum vs serum alone in each arm
The study has been powered around the use of advanced imaging to measure within group changes in ejection fraction at 12 months as the primary end point
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-002706-27 EudraCT | None | None | None |