Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)

• Sponsor: Texas Heart Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00314366
• Collaborator: CHI St. Luke's Health, Texas (Other), Aldagen (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 210
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. After a bone marrow procedure, the special cells are separated and then injected back into the heart around the area of damage with a special guidance and injection system.

Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be consented to the study and extensive baseline testing will be completed at St. Luke's Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has his/her own bone marrow harvested and later injected, if randomized to receive active treatment. The day after the bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4, and months 3 and 6, and at one year unless there is a crossover and then he/she begins baseline again at 6 months and follow-up for one more year. Follow-up testing, including quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Biological: Stem Cell Therapy; Other: Control (plasma)	Phase 1

Detailed Description

This is a phase I, double blind trial to evaluate the use of Aldehyde Dehydrogenase-Bright (ALDHbr) in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous bone marrow cells in patients with end-stage ischemic heart disease is safe, can provide neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study is to assess the safety of the ALDHbr cell injections. The efficacy will be based upon treadmill MVO2. A maximum of 60 patients will be enrolled in the study. At the end of 6 months, after the required testing has been completed, the patients will be told whether they were in the control group or not. The patients in the control group will be given the option to crossover and actually receive stem cell injection. At the time of crossover, which then becomes the baseline, patients will begin the follow-up with all testing including clinic visits for one year for a total of 18 months follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase IB Randomized Controlled Double-Blind Trial of Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells Under Electromechanical Guidance for Therapeutic Angiogenesis
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stem Cell Therapy Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.	Biological: Stem Cell Therapy; Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.; Other Names: NOGA Myostar catheter
Placebo Comparator: Control Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months.	Other: Control (plasma); Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.

Outcome Measures

Primary Outcome Measures

1. Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events [Baseline and 6 months]

   Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).

Secondary Outcome Measures

1. New York Heart Association (NYHA) Classification [Baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)

2. Canadian Cardiovascular (CCS) Angina Score [Baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)

3. Echocardiography (EF)Percent (%) [Baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.

4. Left Ventricular End-Systolic Volume (LVESV) (ml) [baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.

5. Left Ventricular End-Diastolic Volume (LVEDV) [baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.

6. Echocardiography Wall Motion Score Index (WMSI) [baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.

7. Myocardial Oxygen Consumption (MVO2) [baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.

8. Echocardiography (EF) Percent (%) [baseline and 6 months]

   Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.

9. Total Severity Score (Stress) [baseline and 6 months]

   For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling. Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.

10. Total Severity Score (Rest) [baseline and 6 months]

    For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest. Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.

11. Total Severity Score (Reversible) [baseline and 6 months]

    For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress. Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF) symptoms

• Ejection fraction less than or equal to 45%

• Reversible perfusion defect on single photon emission computed tomography (SPECT)

• Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or intervention (stent)

• Able to walk on treadmill

• Hemodynamically stable

Exclusion Criteria:

• Age less than 18 or greater than 70

• Atrial fibrillation

• Severe valve disease

• History of cancer in last 5 years

• HIV positive; hepatitis B or C positive.

• Left ventricular wall thickness less than 8 mm

• Recent heart attack within the last 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Heart Institute/Baylor St. Luke's Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Texas Heart Institute
• CHI St. Luke's Health, Texas
• Aldagen

Investigators

• Principal Investigator: Emerson Perin, MD, PhD, Texas Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The link is to Texas Heart Institute's Stem Cell Department home page.

Publications

• Perin EC, Silva GV, Zheng Y, Gahremanpour A, Canales J, Patel D, Fernandes MR, Keller LH, Quan X, Coulter SA, Moore WH, Herlihy JP, Willerson JT. Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure. Am Heart J. 2012 Mar;163(3):415-21, 421.e1. doi: 10.1016/j.ahj.2011.11.020. Epub 2012 Feb 10.

• Responsible Party: Emerson Perin, MD, PhD, Director Clinical Research for Cardiovascular Medicine and Stem Cell Center, Texas Heart Institute
• ClinicalTrials.gov Identifier: NCT00314366
• Other Study ID Numbers: UT-H-GEN-05-0599
• First Posted: Apr 13, 2006
• Last Update Posted: May 18, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Emerson Perin, MD, PhD, Director Clinical Research for Cardiovascular Medicine and Stem Cell Center, Texas Heart Institute: stem cell; autologous; ischemia
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Period Title: Overall Study
STARTED	11	10
COMPLETED	10	10
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Stem Cell Therapy	Control	Total
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Age	58.2 (6.1)	57.8 (5.5)	58.0 (5.8)
Sex: Female, Male (Count of Participants)
Female	1 10%	2 20%	3 15%
Male	9 90%	8 80%	17 85%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events
Description	Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The data was analyzed for all participants in control and treated groups.

Arm/Group Title	Control	Stem Cell Therapy
Arm/Group Description	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Measure Participants	10	10
Number treated	10 100%	10 100%
atrial arrhythmia	0 0%	2 20%
EMM realted ventricular tachycardia	2 20%	0 0%
EMM related ventricular fibrillation	1 10%	0 0%
cerebrovascular event	1 10%	0 0%
angina exacerbation	1 10%	5 50%
myocardial infarction (NSTEMI)	0 0%	1 10%
intracardiac thrombus	0 0%	1 10%

2. Secondary Outcome

Title	New York Heart Association (NYHA) Classification
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
NYHA baseline	2.5 (0.5)	2.6 (0.5)
NYHA 6 months	2.3 (0.5)	2.1 (0.3)

3. Secondary Outcome

Title	Canadian Cardiovascular (CCS) Angina Score
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
CCS baseline	2.5 (0.5)	2.5 (0.5)
CCS 6 months	2.0 (0.0)	2.0 (0.5)

4. Secondary Outcome

Title	Echocardiography (EF)Percent (%)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
baseline	36.1 (10.9)	32.1 (10.6)
6 months	36.0 (11.3)	34.0 (9.3)

5. Secondary Outcome

Title	Left Ventricular End-Systolic Volume (LVESV) (ml)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	9
LVESV baseline	93.2 (46.1)	94.9 (59.8)
LVESV 6 months	85.9 (46.2)	94.7 (62.2)

6. Secondary Outcome

Title	Left Ventricular End-Diastolic Volume (LVEDV)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
LVDEV baseline	138.3 (43.0)	132.7 (65.2)
LVDED 6 months	127.2 (51.3)	131.3 (67.4)

7. Secondary Outcome

Title	Echocardiography Wall Motion Score Index (WMSI)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
WMSI baseline	1.91 (0.51)	2.13 (0.38)
WMSI 6 months	1.90 (0.57)	2.06 (0.41)

8. Secondary Outcome

Title	Myocardial Oxygen Consumption (MVO2)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

data from 9 stem cell patients at 6 months, 10 at baseline

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	9
MVO2 baseline	15.5 (6.3)	14.1 (4.8)
MVO2 6 months	17.7 (4.1)	14.6 (6.7)

9. Secondary Outcome

Title	Echocardiography (EF) Percent (%)
Description	Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	8	7
EF (%) baseline	38.0 (17.5)	41.9 (11.8)
EF (%) 6 months	40.4 (15.8)	42.2 (7.6)

10. Secondary Outcome

Title	Total Severity Score (Stress)
Description	For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling. Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
Stress Severity Score (stress) baseline	798.2 (528.7)	1007.6 (352.4)
Stress Severity Score (stress) 6 months	785.9 (554.6)	1132 (588.5)

11. Secondary Outcome

Title	Total Severity Score (Rest)
Description	For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest. Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
Total Severity Score (rest) baseline	542.8 (440.7)	812.4 (304.5)
Total Severity Score (rest) 6 months	594.6 (488.9)	828 (396.9)

12. Secondary Outcome

Title	Total Severity Score (Reversible)
Description	For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress. Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined.
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stem Cell Therapy	Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Measure Participants	10	10
Total Severity Score (reversible) baseline	72.6 (95.2)	46.5 (48.5)
Total Severity Score (reversible) 6 months	22.9 (39.2)	87.3 (60.2)

Adverse Events

Time Frame	Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Arm/Group Title	Stem Cell Therapy		Control
Arm/Group Description	Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.		Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
All Cause Mortality
	Stem Cell Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stem Cell Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/10 (100%)		10/10 (100%)
Cardiac disorders
non-ST elevation MI/acute non-ST elevation MI	1/10 (10%)	1	2/10 (20%)	2
ventricular tachycardia /ventricular tachycardia (ICD shocks)/ ventricular arrhythmia	2/10 (20%)	2	2/10 (20%)	2
new stenotic lesion in SVG to RCA	1/10 (10%)	1	0/10 (0%)	0
acute congestive heart failure	0/10 (0%)	0	1/10 (10%)	1
inappropriate AICD function	1/10 (10%)	1	0/10 (0%)	0
hypotension	0/10 (0%)	0	1/10 (10%)	1
ideoventricular rhythm	0/10 (0%)	0	1/10 (10%)	1
ischemic cardiomyopathy	0/10 (0%)	0	1/10 (10%)	1
Eye disorders
bilateral eye cataracts	1/10 (10%)	1	0/10 (0%)	0
left eye macular edema	1/10 (10%)	1	0/10 (0%)	0
Gastrointestinal disorders
cholelithiasis	0/10 (0%)	0	1/10 (10%)	1
General disorders
lightheadness or dizziness	2/10 (20%)	2	0/10 (0%)	0
dehydration	0/10 (0%)	0	1/10 (10%)	1
fever of unknown origin	0/10 (0%)	0	1/10 (10%)	1
Infections and infestations
hospitalization for sinusitis	0/10 (0%)	0	1/10 (10%)	1
Injury, poisoning and procedural complications
postoperative hematoma	1/10 (10%)	1	0/10 (0%)	0
Fentanyl overdose	1/10 (10%)	1	0/10 (0%)	0
mild bleeding at right groin cath site	1/10 (10%)	1	0/10 (0%)	0
Nervous system disorders
intracerebral hemorrhage/ ischemic stroke/ embolic stroke	1/10 (10%)	1	2/10 (20%)	2
Respiratory, thoracic and mediastinal disorders
increased shortness of breath	1/10 (10%)	1	1/10 (10%)	1
community acquired pneumonia	1/10 (10%)	1	0/10 (0%)	0
Vascular disorders
increased claudication	1/10 (10%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Stem Cell Therapy		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/10 (100%)		10/10 (100%)
Blood and lymphatic system disorders
decreased platelet count	0/10 (0%)	0	1/10 (10%)	1
anemia	1/10 (10%)	1	0/10 (0%)	0
Cardiac disorders
second degree AV block, type 2	1/10 (10%)	1	0/10 (0%)	0
irregular heart rhythm	0/10 (0%)	0	1/10 (10%)	1
left ventricular thrombus	0/10 (0%)	0	1/10 (10%)	1
hypotension	2/10 (20%)	3	3/10 (30%)	4
increased troponin level	1/10 (10%)	1	0/10 (0%)	0
increased cardiac chest pain	4/10 (40%)	4	1/10 (10%)	1
atrial fibrillation	1/10 (10%)	1	0/10 (0%)	0
exacerbation of congestive heart failure	0/10 (0%)	0	4/10 (40%)	4
heart racing	0/10 (0%)	0	2/10 (20%)	2
hypertension elevation	1/10 (10%)	1	0/10 (0%)	0
new onset of atrial fibrillation	1/10 (10%)	1	0/10 (0%)	0
increased CPK	0/10 (0%)	0	1/10 (10%)	1
chest pain- nonspecific	0/10 (0%)	0	1/10 (10%)	1
possible apical thrombus	0/10 (0%)	0	1/10 (10%)	1
episode of atypical cardiac chest pain	1/10 (10%)	2	0/10 (0%)	0
left ventricular apical thrombus	1/10 (10%)	1	0/10 (0%)	0
sustained ventricular tachycardia	0/10 (0%)	0	1/10 (10%)	1
diaphoresis	0/10 (0%)	0	1/10 (10%)	1
short periods of atrial fibrillation	1/10 (10%)	1	0/10 (0%)	0
Ear and labyrinth disorders
labyrinthitis	0/10 (0%)	0	1/10 (10%)	1
increased hearing loss	0/10 (0%)	0	1/10 (10%)	1
Endocrine disorders
elevated blood glucose	0/10 (0%)	0	1/10 (10%)	2
low testosterone level	0/10 (0%)	0	1/10 (10%)	1
Eye disorders
photophobia	0/10 (0%)	0	1/10 (10%)	1
Gastrointestinal disorders
stomach flu	1/10 (10%)	1	0/10 (0%)	0
vomiting	1/10 (10%)	1	0/10 (0%)	0
diarrhea	2/10 (20%)	2	0/10 (0%)	0
rectal polyp	1/10 (10%)	1	0/10 (0%)	0
worsening constipation	0/10 (0%)	0	1/10 (10%)	1
epigastric pain	0/10 (0%)	0	1/10 (10%)	1
General disorders
fatigue	3/10 (30%)	4	5/10 (50%)	7
cold symptoms	0/10 (0%)	0	1/10 (10%)	1
nasal discharge	1/10 (10%)	1	0/10 (0%)	0
productive cough	1/10 (10%)	1	0/10 (0%)	0
fever	2/10 (20%)	2	2/10 (20%)	2
obstructive sleep apnea	0/10 (0%)	0	1/10 (10%)	1
headache	2/10 (20%)	2	1/10 (10%)	1
TIA symptoms	0/10 (0%)	0	1/10 (10%)	1
cough	1/10 (10%)	1	0/10 (0%)	0
drowsiness	1/10 (10%)	1	0/10 (0%)	0
nausea	1/10 (10%)	1	2/10 (20%)	3
syncope	1/10 (10%)	1	0/10 (0%)	0
weight loss	1/10 (10%)	1	1/10 (10%)	1
bleeding from bone marrow site	0/10 (0%)	0	1/10 (10%)	1
vertigo	0/10 (0%)	0	1/10 (10%)	1
intermittent right frontal headache	0/10 (0%)	0	1/10 (10%)	1
dehydration	0/10 (0%)	0	1/10 (10%)	1
dizziness, lightheadedness	2/10 (20%)	2	4/10 (40%)	4
weight gain	1/10 (10%)	1	0/10 (0%)	0
abnormal sleep pattern	0/10 (0%)	0	1/10 (10%)	1
nasal congestion	0/10 (0%)	0	2/10 (20%)	3
athlete's foot	0/10 (0%)	0	1/10 (10%)	1
lower extremity edema	0/10 (0%)	0	2/10 (20%)	3
bodyache	0/10 (0%)	0	1/10 (10%)	1
chills	0/10 (0%)	0	1/10 (10%)	1
poison oak exposure	0/10 (0%)	0	1/10 (10%)	1
rash	0/10 (0%)	0	1/10 (10%)	1
Bells Palsey	0/10 (0%)	0	1/10 (10%)	1
rash to neck and upper chest	0/10 (0%)	0	1/10 (10%)	1
rash from Holter	0/10 (0%)	0	1/10 (10%)	1
nose bleed	0/10 (0%)	0	1/10 (10%)	1
tooth decay	0/10 (0%)	0	1/10 (10%)	1
difficulty maintaining sleep	1/10 (10%)	1	0/10 (0%)	0
forgetfullness	1/10 (10%)	1	0/10 (0%)	0
mild headache after 6 min walk	1/10 (10%)	1	0/10 (0%)	0
bruised forehead due to fall	1/10 (10%)	1	0/10 (0%)	0
minor burns (from Halter electrodes)	0/10 (0%)	0	1/10 (10%)	1
flu-like syndrome	0/10 (0%)	0	1/10 (10%)	1
cold feet	1/10 (10%)	1	0/10 (0%)	0
facial numbness	1/10 (10%)	1	0/10 (0%)	0
numbness in extremity	1/10 (10%)	1	0/10 (0%)	0
Hepatobiliary disorders
increased liver function tests	0/10 (0%)	0	1/10 (10%)	1
Immune system disorders
leukocytosis	1/10 (10%)	1	0/10 (0%)	0
Infections and infestations
sinus infection	5/10 (50%)	6	3/10 (30%)	3
strep throat	1/10 (10%)	1	0/10 (0%)	0
viral syndrome	1/10 (10%)	1	0/10 (0%)	0
Herpes Simplex	0/10 (0%)	0	1/10 (10%)	1
influenza	1/10 (10%)	1	1/10 (10%)	1
tooth infection	0/10 (0%)	0	1/10 (10%)	1
infection of right index finger	1/10 (10%)	1	0/10 (0%)	0
Injury, poisoning and procedural complications
pain at bone marrow harvest site	0/10 (0%)	0	1/10 (10%)	1
Metabolism and nutrition disorders
hypoglycemic	0/10 (0%)	0	1/10 (10%)	1
fluctuating glucose	0/10 (0%)	0	1/10 (10%)	1
hyponatremia	0/10 (0%)	0	1/10 (10%)	2
hypokalemia	0/10 (0%)	0	2/10 (20%)	2
symptomatic volume depletion	1/10 (10%)	1	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
cervial neck pain	2/10 (20%)	2	0/10 (0%)	0
bilateral knee pain	0/10 (0%)	0	1/10 (10%)	1
pain in left arm	1/10 (10%)	1	0/10 (0%)	0
left leg cramps	1/10 (10%)	1	0/10 (0%)	0
left chest pain	1/10 (10%)	1	0/10 (0%)	0
bone spurs in neck and spine	1/10 (10%)	1	0/10 (0%)	0
chipped bone fragment in neck	1/10 (10%)	1	0/10 (0%)	0
bulging disk at lower back	0/10 (0%)	0	1/10 (10%)	1
injured miniscus	0/10 (0%)	0	1/10 (10%)	1
bilateral thigh pain	1/10 (10%)	1	0/10 (0%)	0
soreness in feet	1/10 (10%)	1	0/10 (0%)	0
left foot fracture	0/10 (0%)	0	1/10 (10%)	1
sore left arm	0/10 (0%)	0	1/10 (10%)	1
sore left knee	0/10 (0%)	0	1/10 (10%)	1
back tightness	0/10 (0%)	0	1/10 (10%)	1
increase of chronic back pain	0/10 (0%)	0	1/10 (10%)	1
shoulder pain	0/10 (0%)	0	1/10 (10%)	1
bilateral hyperreflexia	0/10 (0%)	0	1/10 (10%)	1
Psychiatric disorders
altered mental status	1/10 (10%)	1	0/10 (0%)	0
anxiety	0/10 (0%)	0	2/10 (20%)	2
increased forgetfulness	0/10 (0%)	0	1/10 (10%)	1
psychological stress	1/10 (10%)	1	0/10 (0%)	0
Renal and urinary disorders
acute renal failure	1/10 (10%)	1	0/10 (0%)	0
urinary tract infection	0/10 (0%)	0	1/10 (10%)	1
elevated blood urea nitrogen (BUN)	0/10 (0%)	0	1/10 (10%)	1
elevated creatinine level	0/10 (0%)	0	1/10 (10%)	1
exacerbation of preexisting disease- kidney stones	0/10 (0%)	0	1/10 (10%)	1
renal insufficiency	0/10 (0%)	0	1/10 (10%)	1
large right renal cyst	1/10 (10%)	1	0/10 (0%)	0
Reproductive system and breast disorders
atrophic vaginitis	0/10 (0%)	0	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
acute bronchitis	1/10 (10%)	1	0/10 (0%)	0
upper respiratory infection	2/10 (20%)	3	1/10 (10%)	1
increased shortness of breath	2/10 (20%)	3	1/10 (10%)	1
non-productive cough	0/10 (0%)	0	1/10 (10%)	1
chest congestion	0/10 (0%)	0	1/10 (10%)	1
emphysema	1/10 (10%)	1	0/10 (0%)	0
Vascular disorders
plantar fascitis	0/10 (0%)	0	2/10 (20%)	2

Limitations/Caveats

The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.