Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474461
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2007-05-15
Brief Title:
Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy SCIPIO
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Myocardial Regeneration Using Cardiac Stem Cells Harvested From Right Atrial Appendages in Patients With Ischemic Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2017-04
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:
SCIPIO
Brief Summary:
The purpose of this study is to investigate the safety of intracoronary cardiac stem cells CSCs therapy in humans Currently there is no effective intervention to regenerate regrow dead heart muscle after a heart attack
The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types According to our hypothesis CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status
The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types According to our hypothesis CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status
Detailed Description:
This will be a randomized open-label study involving 20 patients and 20 controls This study will be done as a collaborative project between Brigham Womens Hospital and The University of Louisville This study is a phase I trial assessing the safety and feasibility of intracoronary autologous CSC harvested from the right atrial appendage RAA transplantation in patients with ischemic cardiomyopathy The study will be conducted in two stages Stage A in which the investigators will obtain an initial assessment of safety and feasibility and stage B in which the investigators will adopt a block randomization strategy that will enable us to assess the feasibility of conducting a subsequent randomized phase II trials While the investigators also hope to have an estimate of efficacy this focus will be the specific aim of future phase II trials All patients who are undergoing on-pump CABG will be screened twice The initial screening will be done to determine the preliminary eligibility before-CABG screening of patients for the study If the patients satisfy the preliminary eligibility criteria stated below the right atrial appendage which is routinely resected during all on-pump bypass surgeries will be collected and processed Thereafter the CSCs will be cultured and expanded from the RAA The second screening will occur an average of 4 1 months after CABG surgery and will utilize a LVEF of 40 assessed by cardiac MRI andor the disk summation method or Simpsons method using echocardiography for final enrollment
The preliminary eligibility criteria will utilize an EF 40 measured by any of the following cardiac imaging tests performed within 2 weeks prior to screening echocardiography gated SPECT andor LV angiography
A maximum of 60 patients who satisfy the preliminary eligibility criteria will be enrolled in the preliminary phase of the study ie will have RAA tissue harvestedculturedexpanded Of these 60 patients a maximum of 20 will be enrolled in the final phase of the study ie will undergo CSC injections and subsequent follow-up
In this open-label study a maximum of 20 patients will eventually receive intracoronary CSC transplantation These patients will have nonviable myocardiumscar from prior MI and will undergo CABG for ICM
Enrollment of patients will be done in two stages Stage A and stage B
In stage A 9 consecutive patients will be enrolled in the treatment arm followed by 4 consecutive patients in the control arm Stage A will enable us to perform an initial assessment of whether the process of harvesting processing and administering cardiac stem cells is associated with commonfrequent short-term adverse effects
In stage B patients will be randomized to the treated and control arms using a 23 ratio with a block size of 5 with a final variable block As a result the total number of both treated and control patients will be 20 each More specifically 11 treated and 16 control patients will make up stage B To ensure that randomization can be done at the time of final enrollment right atrial tissue will be harvested and cardiac stem cells will be grown from all patients who meet the enrollment criteria at the time of initial enrollment If a patient is then randomized to the control arm hisher cells will be discarded
Patients who satisfy the preliminary eligibility criteria will be enrolled and revascularized within few days 2 weeks of enrollment
Patients will receive venous andor arterial grafts as needed during CABG surgery Nonviable myocardial segments will also be revascularized in order to enable subsequent intracoronary delivery of CSCs into the scarred region
During on-pump CABG surgery patients will undergo resection of part of the RAA at the cannulation site this is done routinely during CABG surgery Resected RAA tissue 1 g will be collected intra-operatively and handled as described in the preparation section
Cardiac catheterization coronary angiography for intracoronary injection of CSCs will be performed 4 1 month after CABG surgery
Worldwide more than 500 patients have received intracoronary infusions of stem cells derived from the bone marrow and peripheral blood None of these patients have had any adverse events as a result of these infusions
The overall objective of this project is to determine whether intracoronary delivery of CSCs can regenerate non-viable myocardial segments in patients with ICM CSCs will be harvested from right atrial appendages RAAs of patients with ICM during surgical revascularization cultured and expanded in vitro and then transplanted back into the same patient
The specific aims are
1 To determine the feasibility of harvesting CSCs from RAAs of patients undergoing surgical revascularization culturing and expanding them in vitro and injecting them into patients via the intracoronary route
2 To determine the safety of intracoronary infusion of CSCs
In addition to these safety data we hope to obtain initial evidence that CSC administration results in clinical improvement
The preliminary eligibility criteria will utilize an EF 40 measured by any of the following cardiac imaging tests performed within 2 weeks prior to screening echocardiography gated SPECT andor LV angiography
A maximum of 60 patients who satisfy the preliminary eligibility criteria will be enrolled in the preliminary phase of the study ie will have RAA tissue harvestedculturedexpanded Of these 60 patients a maximum of 20 will be enrolled in the final phase of the study ie will undergo CSC injections and subsequent follow-up
In this open-label study a maximum of 20 patients will eventually receive intracoronary CSC transplantation These patients will have nonviable myocardiumscar from prior MI and will undergo CABG for ICM
Enrollment of patients will be done in two stages Stage A and stage B
In stage A 9 consecutive patients will be enrolled in the treatment arm followed by 4 consecutive patients in the control arm Stage A will enable us to perform an initial assessment of whether the process of harvesting processing and administering cardiac stem cells is associated with commonfrequent short-term adverse effects
In stage B patients will be randomized to the treated and control arms using a 23 ratio with a block size of 5 with a final variable block As a result the total number of both treated and control patients will be 20 each More specifically 11 treated and 16 control patients will make up stage B To ensure that randomization can be done at the time of final enrollment right atrial tissue will be harvested and cardiac stem cells will be grown from all patients who meet the enrollment criteria at the time of initial enrollment If a patient is then randomized to the control arm hisher cells will be discarded
Patients who satisfy the preliminary eligibility criteria will be enrolled and revascularized within few days 2 weeks of enrollment
Patients will receive venous andor arterial grafts as needed during CABG surgery Nonviable myocardial segments will also be revascularized in order to enable subsequent intracoronary delivery of CSCs into the scarred region
During on-pump CABG surgery patients will undergo resection of part of the RAA at the cannulation site this is done routinely during CABG surgery Resected RAA tissue 1 g will be collected intra-operatively and handled as described in the preparation section
Cardiac catheterization coronary angiography for intracoronary injection of CSCs will be performed 4 1 month after CABG surgery
Worldwide more than 500 patients have received intracoronary infusions of stem cells derived from the bone marrow and peripheral blood None of these patients have had any adverse events as a result of these infusions
The overall objective of this project is to determine whether intracoronary delivery of CSCs can regenerate non-viable myocardial segments in patients with ICM CSCs will be harvested from right atrial appendages RAAs of patients with ICM during surgical revascularization cultured and expanded in vitro and then transplanted back into the same patient
The specific aims are
1 To determine the feasibility of harvesting CSCs from RAAs of patients undergoing surgical revascularization culturing and expanding them in vitro and injecting them into patients via the intracoronary route
2 To determine the safety of intracoronary infusion of CSCs
In addition to these safety data we hope to obtain initial evidence that CSC administration results in clinical improvement
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