Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Study Details
Study Description
Brief Summary
This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells 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 visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. The efficacy will be assessed on the basis of the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group (stem cell therapy). Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bone marrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stem Cell Therapy Subject is randomized to receive Stem Cell Therapy (intramyocardial injection of stem cells) via NOGA mapping. |
Device: Intramyocardial Injection of stem cells via NOGA Mapping
Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol.
Other Names:
|
| Other: Control, then Stem Cell Therapy Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
Other: Control, then Stem Cell Therapy
Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety of Autologous-bone-marrow Injections [up to 2 weeks post-procedure, 3 months and 6 months]
Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) 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
- Canadian Cardiovascular (CCS) Angina Score [baseline, 3 months 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)
- New York Heart Association (NYHA)Classification [baseline, 3 months 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)
- Myocardial Oxygen Consumption (MVO2) [baseline, 3 months 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.
- Echocardiography (EF)Percent (%) [baseline, 3 months 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.
- Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) [baseline and 3 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.
- Echocardiography Wall Motion Score Index (WMSI) [baseline and 3 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. 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.
- Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) [baseline, 3 months and 6 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.
- Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) [baseline and 6 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard.
- Left Ventricular End-Diastolic Volume (LVEDV) [baseline, 3 months 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.
- Left Ventricular End-Systolic Volume (LVESV) (ml) [baseline, 3 months 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.
- Endocardial Unipolar Voltages (UPV) [baseline and 6 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.
- Linear Local Shortening (LLS) [baseline and 6 months]
Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
LVEF less than 45%
-
Functional class III or IV angina
-
At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
-
there are additional inc. criteria
Exclusion Criteria:
-
AGe <18 or >70 years of age
-
Constant atrial fibrillation
-
Left ventricular (LV) thrombus
-
History of malignancy in the last 5 years
-
LV wall thickness of < 8 mm at the target site
-
there are additional exclusion criteria
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
Investigators
- Principal Investigator: Emerson Perin, MD,PhD., Texas Heart Institute/Baylor St Luke's Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- HSC-MS-04-141
Study Results
Participant Flow
| Recruitment Details | Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Period Title: Overall Study | ||
| STARTED | 10 | 20 |
| COMPLETED | 9 | 20 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy | Total |
|---|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. | Total of all reporting groups |
| Overall Participants | 10 | 20 | 30 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
10
100%
|
14
70%
|
24
80%
|
| >=65 years |
0
0%
|
6
30%
|
6
20%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.3
(8.6)
|
60.5
(6.4)
|
60.0
(8.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
30%
|
5
25%
|
8
26.7%
|
| Male |
7
70%
|
15
75%
|
22
73.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
20
100%
|
30
100%
|
Outcome Measures
| Title | Safety of Autologous-bone-marrow Injections |
|---|---|
| Description | Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) 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 | up to 2 weeks post-procedure, 3 months and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events which occurred in all participants. |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| post-procedural transient left bundle branch block |
1
10%
|
1
5%
|
| Post-procedure pericardial effusion (nonsignifiant |
0
0%
|
1
5%
|
| Post-procedure transient fever |
1
10%
|
0
0%
|
| Fever (6 months) |
2
20%
|
0
0%
|
| Sustained ventricular arrhythmias (6 months) |
0
0%
|
0
0%
|
| Discharge implantable cardiac defibrillator (6 mo) |
0
0%
|
1
5%
|
| Exacerbation of congestive heart failure (6 mo) |
1
10%
|
2
10%
|
| Myocardial infarction (6 months) |
0
0%
|
0
0%
|
| Death (6 months) |
0
0%
|
0
0%
|
| 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, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| CCS baseline |
3
(0.3)
|
3
(0.2)
|
| CCS 3 months |
2.2
(0.3)
|
2.1
(0.2)
|
| CCS 6 months |
2.6
(0.3)
|
1.8
(0.2)
|
| 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, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| NYHA Baseline |
2.6
(0.3)
|
2.3
(0.2)
|
| NYHA 3 months |
1.9
(0.3)
|
2
(0.2)
|
| NYHA 6 months |
2.4
(0.3)
|
1.8
(0.2)
|
| 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, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| MVO2 (ml/kg per min) baseline |
14.8
(0.8)
|
14.7
(0.6)
|
| MVO2 (ml/kg per min) 3 months |
15.7
(0.8)
|
15.5
(0.6)
|
| MVO2 (ml/kg per min) 6 months |
15.6
(0.9)
|
15.8
(0.6)
|
| 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, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| Echocardiography EF (%) baseline |
39
(9.1)
|
37
(10.6)
|
| Echocardiography EF (%) 3 months |
41
(5.4)
|
38
(5.4)
|
| Echocardiography EF (%) 6 months |
42
(5.4)
|
40
(5.4)
|
| Title | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25. |
| Time Frame | baseline and 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The data was analyzed for all participants in control and treated groups. |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| VE/VCO2 baseline |
29.8
(8)
|
32.7
(6)
|
| VE/VCO2 3 months |
32.8
(5)
|
31.8
(7)
|
| Title | Echocardiography Wall Motion Score Index (WMSI) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. 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 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The data was analyzed for all participants in control and treated groups. |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| Wall Motion Score Index (WMSI) baseline |
1.7
(0.5)
|
1.7
(0.5)
|
| Wall Motion Score Index (WMSI) 3 months |
1.6
(0.4)
|
1.7
(0.6)
|
| Title | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction. |
| Time Frame | baseline, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| SPECT LVEF (%) baseline |
43
(10.4)
|
41.5
(11.2)
|
| SPECT LVEF (%) 3 months |
46.8
(9.5)
|
43.2
(11.1)
|
| SPECT LVEF (%) 6 months |
47.8
(7.5)
|
44
(13.4)
|
| Title | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard. |
| 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| Angiography LVEF (%) baseline |
40
(3.2)
|
37.5
(8.2)
|
| Angiography LVEF (%) 6 months |
40.9
(8.5)
|
42
(14.4)
|
| 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, 3 months and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| LVEDV (ml) baseline |
132.2
(43.6)
|
133.2
(53.6)
|
| LVEDV (ml) 3 months |
125.7
(46.3)
|
123.9
(58.2)
|
| LVEDV (ml) 6 months |
120.0
(30.9)
|
123.9
(39.7)
|
| 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, 3 months 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| LVESV (ml) baseline |
81.7
(40.7)
|
92.9
(50.5)
|
| LVESV (ml) 3 months |
74.4
(37)
|
83.2
(43.2)
|
| LVESV (ml) 6 months |
71.8
(27.2)
|
74
(29.5)
|
| Title | Endocardial Unipolar Voltages (UPV) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV. |
| 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, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| UPV (mV) baseline |
10.2
(4.3)
|
10.5
(5.1)
|
| UPV (mV) 6 months |
10.1
(4.8)
|
10.8
(5.4)
|
| Title | Linear Local Shortening (LLS) |
|---|---|
| Description | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction. |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy |
|---|---|---|
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Measure Participants | 10 | 20 |
| LLS (%) baseline |
12.1
(6.8)
|
10.5
(7.3)
|
| LLS (%) 6 months |
9.1
(6.4)
|
10.8
(6.8)
|
Adverse Events
| Time Frame | Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Control, Then Stem Cell Therapy | Stem Cell Therapy | ||
| Arm/Group Description | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. | ||
All Cause Mortality |
||||
| Control, Then Stem Cell Therapy | Stem Cell Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Control, Then Stem Cell Therapy | Stem Cell Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/10 (70%) | 11/20 (55%) | ||
| Cardiac disorders | ||||
| Chest pain and slightly elevated Troponin I | 0/10 (0%) | 0 | 1/20 (5%) | 2 |
| Elevated troponin,chestpain and fever with episode of cellulitis | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Hospitalized for chest pain | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Hospitalized for heart failure at one year | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Myocardial infarction | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Placement of AICD | 2/10 (20%) | 2 | 1/20 (5%) | 1 |
| Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Replacement of AICD | 1/10 (10%) | 1 | 2/20 (10%) | 2 |
| Restenosis without symptoms at 6 months, received stent | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| Troponin I elevation in presence of new onset Atrial fibrillation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| bronchitis, decompensated heart failure | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| decompensated heart failure | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| elevated Troponin T in presence of bacteremia | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| supraventricular tachycardia ablation | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| unstable angina and stent | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| urosepsis and chest pain | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| ventricular tachycardia during 6 month F/Ucath requiring cardioversion | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| Infections and infestations | ||||
| False positive culture on processed stem cells at day 5 | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Staph aureus septicemia (left sternoclavicular area) leg | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| back pain | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Nervous system disorders | ||||
| Confusion/disorientation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Renal and urinary disorders | ||||
| Urosepsis | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pulmonary edema within 24 hrs of treatment | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| Upper respiratory infection | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Control, Then Stem Cell Therapy | Stem Cell Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/10 (90%) | 18/20 (90%) | ||
| Blood and lymphatic system disorders | ||||
| anemia | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| bloody nose | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| decrease in platelets/ hematocrit | 2/10 (20%) | 3 | 0/20 (0%) | 0 |
| edema, extremity not specified | 1/10 (10%) | 2 | 4/20 (20%) | 7 |
| edema, upper extremities | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| gout, increased symptoms | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| scrotal edema/ erythema | 0/10 (0%) | 0 | 1/20 (5%) | 2 |
| swelling/ edema lower extremities | 2/10 (20%) | 2 | 10/20 (50%) | 17 |
| swelling/ edema upper extremity | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Cardiac disorders | ||||
| changes in cardiac enzymes (CK-MB,BNP,CRP, troponin) | 1/10 (10%) | 1 | 5/20 (25%) | 9 |
| changes in heart rate | 2/10 (20%) | 3 | 3/20 (15%) | 4 |
| chest pain/ increased chest pain | 4/10 (40%) | 6 | 16/20 (80%) | 23 |
| electrocardiogram changes | 0/10 (0%) | 0 | 4/20 (20%) | 17 |
| heart failure | 0/10 (0%) | 0 | 2/20 (10%) | 4 |
| heart palpitations | 2/10 (20%) | 2 | 2/20 (10%) | 2 |
| hypertension | 0/10 (0%) | 0 | 6/20 (30%) | 6 |
| hypotension | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| myocardial infaction, non-ST elevation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| pleuritic chest pain | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| shortness of breath, lying down | 1/10 (10%) | 1 | 1/20 (5%) | 1 |
| Endocrine disorders | ||||
| diabetes uncontrolled | 0/10 (0%) | 0 | 1/20 (5%) | 3 |
| hyperglycermia | 1/10 (10%) | 1 | 2/20 (10%) | 3 |
| hypoglycemia | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| Eye disorders | ||||
| abnormalities/ pain eye | 1/10 (10%) | 1 | 1/20 (5%) | 1 |
| blurred vision | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| eyes sensitive to light | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| Gastrointestinal disorders | ||||
| abdominal bloating | 1/10 (10%) | 1 | 2/20 (10%) | 2 |
| constipation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| cramping | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| diarrhea | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| digestive problems | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| gastroespohageal reflux | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| heartburn | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| nausea | 2/10 (20%) | 2 | 1/20 (5%) | 1 |
| General disorders | ||||
| ICD firing | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| abnormality on MRI scan | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| albumin, increase | 1/10 (10%) | 2 | 0/20 (0%) | 0 |
| cold/ congestion | 2/10 (20%) | 2 | 5/20 (25%) | 7 |
| diaphoresis | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| disorientation | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| dizziness/ light-headedness | 3/10 (30%) | 3 | 5/20 (25%) | 8 |
| fall/ balance problems | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| fatigue/ weakness | 2/10 (20%) | 2 | 7/20 (35%) | 11 |
| fever | 3/10 (30%) | 3 | 2/20 (10%) | 3 |
| gum bleeding | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| headache | 4/10 (40%) | 4 | 4/20 (20%) | 4 |
| hematoma at catheter site | 3/10 (30%) | 4 | 3/20 (15%) | 5 |
| insomnia/ sleep disorders | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| sinus congestion/ compliant | 2/10 (20%) | 2 | 2/20 (10%) | 6 |
| soreness/ brusing | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| spider bite | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| weight gain | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| Infections and infestations | ||||
| abcess tooth | 1/10 (10%) | 1 | 1/20 (5%) | 1 |
| carbuncles on body | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| cellulitis | 0/10 (0%) | 0 | 2/20 (10%) | 3 |
| chills | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| influenza/ flu-like symptoms | 2/10 (20%) | 2 | 1/20 (5%) | 1 |
| lesion right foot | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| shingles | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| upper respiratory infection | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| virus | 1/10 (10%) | 1 | 1/20 (5%) | 1 |
| white blood count, elevated | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| abcess left sternovascular joint | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| back/ hip pain | 4/10 (40%) | 4 | 9/20 (45%) | 16 |
| bone fracture | 2/10 (20%) | 2 | 0/20 (0%) | 0 |
| bone pain, extremities | 1/10 (10%) | 4 | 3/20 (15%) | 4 |
| carpel tunnel release | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| muscle pain/pull | 0/10 (0%) | 0 | 3/20 (15%) | 3 |
| numbness/ tingling in extremities | 1/10 (10%) | 1 | 4/20 (20%) | 9 |
| sciatica | 0/10 (0%) | 0 | 1/20 (5%) | 2 |
| shoulder pain | 1/10 (10%) | 2 | 4/20 (20%) | 4 |
| tremors | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Nervous system disorders | ||||
| slurred speech/ dysphasia | 0/10 (0%) | 0 | 2/20 (10%) | 2 |
| Psychiatric disorders | ||||
| anxiety | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| depression | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| Renal and urinary disorders | ||||
| changes in renal enzymes (BUN, creatinine, chloride) | 1/10 (10%) | 1 | 2/20 (10%) | 2 |
| renal insufficiency/ urinary problems | 1/10 (10%) | 3 | 0/20 (0%) | 0 |
| urinary tract infection | 1/10 (10%) | 1 | 1/20 (5%) | 2 |
| urinary/ bladder problems | 1/10 (10%) | 1 | 1/20 (5%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||
| bronchitis | 2/10 (20%) | 2 | 3/20 (15%) | 3 |
| chronic obtructive pulmonary disease, increased symptoms | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| cough | 3/10 (30%) | 3 | 3/20 (15%) | 5 |
| crackles/ wheezes in lungs | 1/10 (10%) | 1 | 3/20 (15%) | 6 |
| probable obstructive sleep apnea | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| pulmonary edema | 1/10 (10%) | 1 | 1/20 (5%) | 1 |
| shortness of breath/ increased shortness of breath/ difficulty breathing | 4/10 (40%) | 6 | 7/20 (35%) | 9 |
| Skin and subcutaneous tissue disorders | ||||
| itching | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| petechia | 1/10 (10%) | 1 | 0/20 (0%) | 0 |
| psoriasis | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
| skin flushing | 0/10 (0%) | 0 | 1/20 (5%) | 1 |
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Emerson C. Perin, M.D., Ph.D. |
|---|---|
| Organization | Texas Heart Institute |
| Phone | 832-355-9405 |
| eperin@texasheart.org |
- HSC-MS-04-141