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

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ClinicalTrials.gov Identifier: NCT00314366
Recruitment Status : Active, not recruiting
First Posted : April 13, 2006
Results First Posted : November 23, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
CHI St. Luke's Health, Texas
Aldagen
Information provided by (Responsible Party):
Emerson Perin, MD, PhD, Texas Heart Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Biological: Stem Cell Therapy
Other: Control (plasma)
Enrollment 21
Recruitment Details Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.
Pre-assignment Details  
Arm/Group Title Stem Cell Therapy Control
Hide 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
Reason Not Completed
not treated due to patient medical condi             1             0
Arm/Group Title Stem Cell Therapy Control Total
Hide 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 Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 10 participants 10 participants 20 participants
58.2  (6.1) 57.8  (5.5) 58.0  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
1
  10.0%
2
  20.0%
3
  15.0%
Male
9
  90.0%
8
  80.0%
17
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events
Hide 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
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Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control Stem Cell Therapy
Hide 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.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
Number treated 10 10
atrial arrhythmia 0 2
EMM realted ventricular tachycardia 2 0
EMM related ventricular fibrillation 1 0
cerebrovascular event 1 0
angina exacerbation 1 5
myocardial infarction (NSTEMI) 0 1
intracardiac thrombus 0 1
2.Secondary Outcome
Title New York Heart Association (NYHA) Classification
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: NYHA Functional class
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
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 (%)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of blood
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: ml
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ml
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
data from 9 stem cell patients at 6 months, 10 at baseline
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
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 (%)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: percentage of blood
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Therapy Control
Hide 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.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Therapy Control
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stem Cell Therapy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)    
Cardiac disorders     
non-ST elevation MI/acute non-ST elevation MI   1/10 (10.00%)  1 2/10 (20.00%)  2
ventricular tachycardia /ventricular tachycardia (ICD shocks)/ ventricular arrhythmia   2/10 (20.00%)  2 2/10 (20.00%)  2
new stenotic lesion in SVG to RCA   1/10 (10.00%)  1 0/10 (0.00%)  0
acute congestive heart failure   0/10 (0.00%)  0 1/10 (10.00%)  1
inappropriate AICD function   1/10 (10.00%)  1 0/10 (0.00%)  0
hypotension   0/10 (0.00%)  0 1/10 (10.00%)  1
ideoventricular rhythm   0/10 (0.00%)  0 1/10 (10.00%)  1
ischemic cardiomyopathy   0/10 (0.00%)  0 1/10 (10.00%)  1
Eye disorders     
bilateral eye cataracts   1/10 (10.00%)  1 0/10 (0.00%)  0
left eye macular edema   1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders     
cholelithiasis   0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders     
lightheadness or dizziness *  2/10 (20.00%)  2 0/10 (0.00%)  0
dehydration   0/10 (0.00%)  0 1/10 (10.00%)  1
fever of unknown origin   0/10 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations     
hospitalization for sinusitis   0/10 (0.00%)  0 1/10 (10.00%)  1
Injury, poisoning and procedural complications     
postoperative hematoma   1/10 (10.00%)  1 0/10 (0.00%)  0
Fentanyl overdose   1/10 (10.00%)  1 0/10 (0.00%)  0
mild bleeding at right groin cath site *  1/10 (10.00%)  1 0/10 (0.00%)  0
Nervous system disorders     
intracerebral hemorrhage/ ischemic stroke/ embolic stroke   1/10 (10.00%)  1 2/10 (20.00%)  2
Respiratory, thoracic and mediastinal disorders     
increased shortness of breath *  1/10 (10.00%)  1 1/10 (10.00%)  1
community acquired pneumonia   1/10 (10.00%)  1 0/10 (0.00%)  0
Vascular disorders     
increased claudication *  1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Stem Cell Therapy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
decreased platelet count   0/10 (0.00%)  0 1/10 (10.00%)  1
anemia   1/10 (10.00%)  1 0/10 (0.00%)  0
Cardiac disorders     
second degree AV block, type 2   1/10 (10.00%)  1 0/10 (0.00%)  0
irregular heart rhythm *  0/10 (0.00%)  0 1/10 (10.00%)  1
left ventricular thrombus   0/10 (0.00%)  0 1/10 (10.00%)  1
hypotension   2/10 (20.00%)  3 3/10 (30.00%)  4
increased troponin level   1/10 (10.00%)  1 0/10 (0.00%)  0
increased cardiac chest pain *  4/10 (40.00%)  4 1/10 (10.00%)  1
atrial fibrillation *  1/10 (10.00%)  1 0/10 (0.00%)  0
exacerbation of congestive heart failure *  0/10 (0.00%)  0 4/10 (40.00%)  4
heart racing *  0/10 (0.00%)  0 2/10 (20.00%)  2
hypertension elevation   1/10 (10.00%)  1 0/10 (0.00%)  0
new onset of atrial fibrillation *  1/10 (10.00%)  1 0/10 (0.00%)  0
increased CPK   0/10 (0.00%)  0 1/10 (10.00%)  1
chest pain- nonspecific *  0/10 (0.00%)  0 1/10 (10.00%)  1
possible apical thrombus *  0/10 (0.00%)  0 1/10 (10.00%)  1
episode of atypical cardiac chest pain *  1/10 (10.00%)  2 0/10 (0.00%)  0
left ventricular apical thrombus *  1/10 (10.00%)  1 0/10 (0.00%)  0
sustained ventricular tachycardia *  0/10 (0.00%)  0 1/10 (10.00%)  1
diaphoresis *  0/10 (0.00%)  0 1/10 (10.00%)  1
short periods of atrial fibrillation *  1/10 (10.00%)  1 0/10 (0.00%)  0
Ear and labyrinth disorders     
labyrinthitis *  0/10 (0.00%)  0 1/10 (10.00%)  1
increased hearing loss *  0/10 (0.00%)  0 1/10 (10.00%)  1
Endocrine disorders     
elevated blood glucose   0/10 (0.00%)  0 1/10 (10.00%)  2
low testosterone level   0/10 (0.00%)  0 1/10 (10.00%)  1
Eye disorders     
photophobia *  0/10 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders     
stomach flu *  1/10 (10.00%)  1 0/10 (0.00%)  0
vomiting *  1/10 (10.00%)  1 0/10 (0.00%)  0
diarrhea *  2/10 (20.00%)  2 0/10 (0.00%)  0
rectal polyp *  1/10 (10.00%)  1 0/10 (0.00%)  0
worsening constipation *  0/10 (0.00%)  0 1/10 (10.00%)  1
epigastric pain *  0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders     
fatigue *  3/10 (30.00%)  4 5/10 (50.00%)  7
cold symptoms *  0/10 (0.00%)  0 1/10 (10.00%)  1
nasal discharge *  1/10 (10.00%)  1 0/10 (0.00%)  0
productive cough *  1/10 (10.00%)  1 0/10 (0.00%)  0
fever   2/10 (20.00%)  2 2/10 (20.00%)  2
obstructive sleep apnea *  0/10 (0.00%)  0 1/10 (10.00%)  1
headache *  2/10 (20.00%)  2 1/10 (10.00%)  1
TIA symptoms *  0/10 (0.00%)  0 1/10 (10.00%)  1
cough *  1/10 (10.00%)  1 0/10 (0.00%)  0
drowsiness *  1/10 (10.00%)  1 0/10 (0.00%)  0
nausea *  1/10 (10.00%)  1 2/10 (20.00%)  3
syncope *  1/10 (10.00%)  1 0/10 (0.00%)  0
weight loss *  1/10 (10.00%)  1 1/10 (10.00%)  1
bleeding from bone marrow site *  0/10 (0.00%)  0 1/10 (10.00%)  1
vertigo *  0/10 (0.00%)  0 1/10 (10.00%)  1
intermittent right frontal headache *  0/10 (0.00%)  0 1/10 (10.00%)  1
dehydration *  0/10 (0.00%)  0 1/10 (10.00%)  1
dizziness, lightheadedness *  2/10 (20.00%)  2 4/10 (40.00%)  4
weight gain *  1/10 (10.00%)  1 0/10 (0.00%)  0
abnormal sleep pattern *  0/10 (0.00%)  0 1/10 (10.00%)  1
nasal congestion *  0/10 (0.00%)  0 2/10 (20.00%)  3
athlete's foot *  0/10 (0.00%)  0 1/10 (10.00%)  1
lower extremity edema *  0/10 (0.00%)  0 2/10 (20.00%)  3
bodyache *  0/10 (0.00%)  0 1/10 (10.00%)  1
chills *  0/10 (0.00%)  0 1/10 (10.00%)  1
poison oak exposure *  0/10 (0.00%)  0 1/10 (10.00%)  1
rash *  0/10 (0.00%)  0 1/10 (10.00%)  1
Bells Palsey *  0/10 (0.00%)  0 1/10 (10.00%)  1
rash to neck and upper chest *  0/10 (0.00%)  0 1/10 (10.00%)  1
rash from Holter *  0/10 (0.00%)  0 1/10 (10.00%)  1
nose bleed *  0/10 (0.00%)  0 1/10 (10.00%)  1
tooth decay *  0/10 (0.00%)  0 1/10 (10.00%)  1
difficulty maintaining sleep *  1/10 (10.00%)  1 0/10 (0.00%)  0
forgetfullness *  1/10 (10.00%)  1 0/10 (0.00%)  0
mild headache after 6 min walk *  1/10 (10.00%)  1 0/10 (0.00%)  0
bruised forehead due to fall *  1/10 (10.00%)  1 0/10 (0.00%)  0
minor burns (from Halter electrodes) *  0/10 (0.00%)  0 1/10 (10.00%)  1
flu-like syndrome *  0/10 (0.00%)  0 1/10 (10.00%)  1
cold feet *  1/10 (10.00%)  1 0/10 (0.00%)  0
facial numbness *  1/10 (10.00%)  1 0/10 (0.00%)  0
numbness in extremity *  1/10 (10.00%)  1 0/10 (0.00%)  0
Hepatobiliary disorders     
increased liver function tests *  0/10 (0.00%)  0 1/10 (10.00%)  1
Immune system disorders     
leukocytosis *  1/10 (10.00%)  1 0/10 (0.00%)  0
Infections and infestations     
sinus infection *  5/10 (50.00%)  6 3/10 (30.00%)  3
strep throat *  1/10 (10.00%)  1 0/10 (0.00%)  0
viral syndrome *  1/10 (10.00%)  1 0/10 (0.00%)  0
Herpes Simplex *  0/10 (0.00%)  0 1/10 (10.00%)  1
influenza *  1/10 (10.00%)  1 1/10 (10.00%)  1
tooth infection *  0/10 (0.00%)  0 1/10 (10.00%)  1
infection of right index finger *  1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications     
pain at bone marrow harvest site *  0/10 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders     
hypoglycemic *  0/10 (0.00%)  0 1/10 (10.00%)  1
fluctuating glucose   0/10 (0.00%)  0 1/10 (10.00%)  1
hyponatremia   0/10 (0.00%)  0 1/10 (10.00%)  2
hypokalemia   0/10 (0.00%)  0 2/10 (20.00%)  2
symptomatic volume depletion *  1/10 (10.00%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders     
cervial neck pain *  2/10 (20.00%)  2 0/10 (0.00%)  0
bilateral knee pain *  0/10 (0.00%)  0 1/10 (10.00%)  1
pain in left arm *  1/10 (10.00%)  1 0/10 (0.00%)  0
left leg cramps *  1/10 (10.00%)  1 0/10 (0.00%)  0
left chest pain *  1/10 (10.00%)  1 0/10 (0.00%)  0
bone spurs in neck and spine *  1/10 (10.00%)  1 0/10 (0.00%)  0
chipped bone fragment in neck *  1/10 (10.00%)  1 0/10 (0.00%)  0
bulging disk at lower back *  0/10 (0.00%)  0 1/10 (10.00%)  1
injured miniscus *  0/10 (0.00%)  0 1/10 (10.00%)  1
bilateral thigh pain *  1/10 (10.00%)  1 0/10 (0.00%)  0
soreness in feet *  1/10 (10.00%)  1 0/10 (0.00%)  0
left foot fracture *  0/10 (0.00%)  0 1/10 (10.00%)  1
sore left arm *  0/10 (0.00%)  0 1/10 (10.00%)  1
sore left knee *  0/10 (0.00%)  0 1/10 (10.00%)  1
back tightness *  0/10 (0.00%)  0 1/10 (10.00%)  1
increase of chronic back pain *  0/10 (0.00%)  0 1/10 (10.00%)  1
shoulder pain *  0/10 (0.00%)  0 1/10 (10.00%)  1
bilateral hyperreflexia *  0/10 (0.00%)  0 1/10 (10.00%)  1
Psychiatric disorders     
altered mental status   1/10 (10.00%)  1 0/10 (0.00%)  0
anxiety *  0/10 (0.00%)  0 2/10 (20.00%)  2
increased forgetfulness *  0/10 (0.00%)  0 1/10 (10.00%)  1
psychological stress *  1/10 (10.00%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
acute renal failure   1/10 (10.00%)  1 0/10 (0.00%)  0
urinary tract infection *  0/10 (0.00%)  0 1/10 (10.00%)  1
elevated blood urea nitrogen (BUN) *  0/10 (0.00%)  0 1/10 (10.00%)  1
elevated creatinine level *  0/10 (0.00%)  0 1/10 (10.00%)  1
exacerbation of preexisting disease- kidney stones *  0/10 (0.00%)  0 1/10 (10.00%)  1
renal insufficiency *  0/10 (0.00%)  0 1/10 (10.00%)  1
large right renal cyst *  1/10 (10.00%)  1 0/10 (0.00%)  0
Reproductive system and breast disorders     
atrophic vaginitis *  0/10 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
acute bronchitis   1/10 (10.00%)  1 0/10 (0.00%)  0
upper respiratory infection *  2/10 (20.00%)  3 1/10 (10.00%)  1
increased shortness of breath *  2/10 (20.00%)  3 1/10 (10.00%)  1
non-productive cough *  0/10 (0.00%)  0 1/10 (10.00%)  1
chest congestion *  0/10 (0.00%)  0 1/10 (10.00%)  1
emphysema *  1/10 (10.00%)  1 0/10 (0.00%)  0
Vascular disorders     
plantar fascitis *  0/10 (0.00%)  0 2/10 (20.00%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emerson C. Perin, M.D., Ph.D.
Organization: Texas Heart Institute
Phone: 832-355-9405
Responsible Party: Emerson Perin, MD, PhD, Texas Heart Institute
ClinicalTrials.gov Identifier: NCT00314366     History of Changes
Other Study ID Numbers: UT-H-GEN-05-0599
First Submitted: April 10, 2006
First Posted: April 13, 2006
Results First Submitted: June 5, 2015
Results First Posted: November 23, 2015
Last Update Posted: October 9, 2018