Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
- Conditions
- Myocardial Infarction
- Interventions
- Drug: PlaceboBiological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
- Registration Number
- NCT01458405
- Lead Sponsor
- Capricor Inc.
- Brief Summary
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 135
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - CAP-1002 Allogeneic Cardiosphere-Derived Cells CAP-1002 Allogeneic Cardiosphere-Derived Cells -
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Any of the Adjudicated Events Within 1-month post-infusion Adjudicated Events reported included: Acute myocarditis; Death due to ventricular tachycardia (VT) or ventricular fibrillation (VF); Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); and Major adverse cardiac event (MACE) (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, left ventricular assist device \[LVAD\] placement or heart transplant).
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 12 Baseline, Month 12 Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of left ventricular (LV) areas from all sections (including those without infarct scar) and multiplying by 100. Percent improvement in infarct size defined by scar as a percent of LV mass was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Baseline, Month 6 and Month 12 LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). LVEF expressed as percentage ejection fraction was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Baseline, Month 6 and Month 12 The regions assessed of the heart were: Anterior, Lateral, Inferior and Septal. Tissue mass recovery in the function of region receiving therapy expressed as percentage improvement was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Change From Baseline in Six-Minute Walk Test at Month 6 and 12 Baseline, Month 6 and Month 12 The six-minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes.
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12 Baseline, Month 6 and Month 12 Health related quality of life is measured using the Minnesota Living with Heart Failure questionnaire (MLHFQ). The MLHFQ is a patient-reported outcome to measure the patient's perceptions of the influence of heart failure on physical and emotional aspects of life. The questionnaire has 21 items to assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and emotional functions. Responses are recorded on six-point Likert scales, ranging from 0 (none) to 5 (very much). Total Scores are summed to a range of 0-105, in which with higher scores indicate worse health-related quality of life.
Number of Participants Experiencing Any of the Adjudicated Events Up to Month 12 post-infusion Adjudicated Events reported included: Acute myocarditis; Death due to VT or VF; Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); MACE (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, LVAD placement or heart transplant); New cardiac tumor formation on MRI imaging; Any hospitalization due to cardiovascular cause; Any inter-current cardiovascular illness or one related to CAP-1002 or placebo infusion, which prolongs hospitalization; New thrombolysis in myocardial infarction (TIMI) flow \<=1; Development of, or an increase in frequency of VT; Development of increased anti-human leukocyte antigen (anti-HLA) antibody levels (mean fluorescence intensity \[MFI\] \>= 1000; 5000) with development of sensitization to HLA antigens specific to CAP-1002 cardiosphere-derived cells donor.
Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12 Baseline, Month 6 and Month 12 LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Percent change in LVEF was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Baseline, Month 6 and Month 12 LVEDV is the amount of blood in the heart's left ventricle just before the heart contracts. LVEDV was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12 Baseline, Month 6 and Month 12 LVEDV is the amount of blood in the heart's left ventricle just before the heart contracts. Percent change in LVEDV was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Baseline, Month 6 and Month 12 LVESV is the amount of blood remaining in the ventricle at the end of systole, after the heart has contracted. LVESV was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12 Baseline, Month 6 and Month 12 LVESV is the amount of blood remaining in the ventricle at the end of systole, after the heart has contracted. Percent change in LVESV was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Baseline, Month 6 and Month 12 Infarct size in grams was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12 Baseline, Month 6 and Month 12 Percent change in infarct size was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Absolute Change From Baseline in Viable Mass at Month 6 and 12 Baseline, Month 6 and Month 12 Viable mass expressed in grams was assessed by magnetic resonance imaging. Myocardial viable mass refers to myocardial cells that are alive after myocardial injury, according to cellular, metabolic and contractile functions. Absolute change was calculated as: post-baseline value-Baseline value.
Percent Change From Baseline in Viable Mass at Month 6 and12 Baseline, Month 6 and Month 12 Percent change in viable mass was assessed by magnetic resonance imaging. Myocardial viable mass refers to myocardial cells that are alive after myocardial injury, according to cellular, metabolic and contractile functions. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12 Baseline, Month 6 and Month 12 The regions assessed of the heart were: Anterior, Lateral, Inferior and Septal. Tissue mass recovery in the function of region receiving therapy expressed as percentage improvement was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12 Baseline, Month 6 and Month 12 The Short Form (36) Health Survey is a 36-item, patient-reported survey of participant health. The SF-36 consists of eight scaled scores (Physical Function, Physical Health, Emotional Problems, Energy/Fatigue, Emotional Well-Being, Social Functioning, Pain Scale and General Health) which are the weighted sums of the questions in their section. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better participant status.
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12 Baseline, Month 6 and Month 12 Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of LV areas from all sections (including those without infarct scar) and multiplying by 100. Improvement in infarct size as a percent of LV mass was assessed by magnetic resonance imaging.
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12 Baseline, Month 6 and Month 12 WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities during the last 7 days. Four scores are derived as percent: Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment. Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity.
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12 Baseline, Month 6 and Month 12 PGA will ask participants to assess how their overall status has changed since prior to receiving the therapy. Possible PGA responses are "0=none", "1=mild", "2=moderate", "and 3=severe". Change from Baseline was calculated as lowest PGA score on scheduled visits minus PGA score at Baseline which resulted in possible ranges from -3 to +3. Decreasing scores indicate improvement.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12 Baseline, Month 6 and Month 12 New York Heart Association (NYHA) Classification: Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Change from Baseline was calculated as lowest NYHA score on scheduled visits minus NYHA score at Baseline which resulted in possible ranges from -3 to +3. Decreasing scores indicate improvement.
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Baseline, Month 6 and Month 12 NT-proBNP was the cardiac biomarkers assessed through serum sample.
Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12 Baseline, Month 6 and Month 12 NT-proBNP was the cardiac biomarkers assessed through serum sample.
Trial Locations
- Locations (32)
SUMMA Health System
🇺🇸Akron, Ohio, United States
University of Florida - Shands Hospital
🇺🇸Gainesville, Florida, United States
Austin Heart
🇺🇸Austin, Texas, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Scripps
🇺🇸La Jolla, California, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Metropolitan Heart and Vascular Institute / Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Swedish Medical Center - Heart and Vascular Research
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Lindner Center for Research and Education at the Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Prairie Heart - St. John's Hospital
🇺🇸Springfield, Illinois, United States
Michigan CardioVascular Institute
🇺🇸Saginaw, Michigan, United States
NC Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Carolinas HealthCare System
🇺🇸Charlotte, North Carolina, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Texas Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States