Myocardial InfarctionPhase 1/2ALLSTARNCT01458405
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
A Phase 1/2 study testing CAP-1002 Allogeneic Cardiosphere-Derived Cells in people with Myocardial Infarction, run by Capricor Inc. at 32 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- CAP-1002 Allogeneic Cardiosphere-Derived Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 32 sitesUnited States
- Study dates
- 13 Nov 2012to 28 Feb 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or Creatine phosphokinase MB isoenzyme (CK-MB) >5 times the upper limit of normal. Also at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
- History of percutaneous coronary intervention (PCI), with stent placement resulting in Thrombolysis in Myocardial Infarction (TIMI) flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
- At least one assessment of left ventricular ejection function (LVEF) <=0.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period.
- For participants that fulfill the criteria of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and the most recent test prior to or during the screening period.
- For participants that fulfill the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to or during the screening period.
- Note: participants may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.
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- Left ventricular infarct size of >= 15% of left ventricular mass in the qualifying infarct-related region to be infused as determined by centrally read screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the infarcted regions.
- No further revascularization clinically indicated at the time the participants is assessed for participation in the clinical trial.
- Ability to provide informed consent and follow-up with protocol procedures.
- Age >= 18 years.
Who cannot join
- Participants with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.
- Diagnosed or suspected myocarditis.
- History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
- History of acute coronary syndrome in the 4 weeks prior to study infusion.
- History of previous stem cell therapy.
- History of radiation treatment to the central or left side of thorax.
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- Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic recurrent or persistent pericarditis.
- History of or current treatment with immunosuppressive, anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-vascular endothelial growth factor, or chemotherapeutic agents within 3 months prior to enrollment.
- Prior implantable cardioverter defibrillator (ICD) and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in participants with ICD and/or pacemaker placement.
- Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions are excluded: i. Manufactured before the year 2000, ii. Leads implanted < 6 weeks prior to signing informed consent, iii. Non-transvenous epicardial, abandoned, or no-fixation leads, iv. Subcutaneous ICDs, v. Leadless pacemakers, vi. Any other condition that, in the judgement of device-trained staff, would deem an MRI contraindicated.
- Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded).
- A cardiac resynchronization therapy (CRT) device implanted < 3 months prior to signing informed consent.
- Estimated glomerular filtration rate < 30 mL/min.
- Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days.
- Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
- Current alcohol or drug abuse.
- Pregnant/nursing women and women of child-bearing potential that do not agree to use at least two forms of active and highly reliable method(s) of contraception. Acceptable methods of contraception include contraceptive pills, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide or gel, or an intrauterine device (IUD).
- Human Immunodeficiency Virus (HIV) infection.
- Viral hepatitis.
- Uncontrolled diabetes (HbA1c>9%).
- Abnormal liver function (Serum Glutamic Pyruvic Transaminase/Alanine aminotransferase > 3 times the upper reference range) and/or abnormal hematology (hematocrit < 25%, White Blood Cell < 3000 µl, platelets < 100,000 µl) studies without a reversible, identifiable cause.
- Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats, not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new acute ischemic episode.
- Ventricular fibrillation not associated with a new acute ischemic episode.
- New York Heart Association (NYHA) Class IV congestive heart failure.
- Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
- Any prior transplant.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Known hypersensitivity to bovine products.
- Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the informed consent form.
- Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the participants unsuitable for the study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
SUMMA Health System
Akron, Ohio, 44304
Austin Heart
Austin, Texas, 78756
Cardiology, P.C.
Birmingham, Alabama, 35211
University at Buffalo
Buffalo, New York, 14203
University of Vermont Medical Center
Burlington, Vermont, 05401
Carolinas HealthCare System
Charlotte, North Carolina
Rush University Medical Center
Chicago, Illinois, 60612
Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43201
OhioHealth Research Institute
Columbus, Ohio, 43214
Metropolitan Heart and Vascular Institute / Mercy Hospital
Coon Rapids, Minnesota, 55433
Duke University Hospital
Durham, North Carolina, 27710
University of Florida - Shands Hospital
Gainesville, Florida, 32610
University of Texas Memorial Hermann Hospital
Houston, Texas, 77030
Heart Center Research
Huntsville, Alabama, 35801
Kansas University Medical Center
Kansas City, Kansas, 66160
Scripps
La Jolla, California, 92037
University of Kentucky
Lexington, Kentucky, 40536
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Aurora Research Institute
Milwaukee, Wisconsin, 53233
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Lenox Hill Hospital
New York, New York, 10075
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
The Miriam Hospital
Providence, Rhode Island, 02906
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Michigan CardioVascular Institute
Saginaw, Michigan, 48602
University of Utah
Salt Lake City, Utah, 84132
Swedish Medical Center - Heart and Vascular Research
Seattle, Washington, 98122
University of Washington
Seattle, Washington, 98195
Prairie Heart - St. John's Hospital
Springfield, Illinois, 62712
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction
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.
- Conditions
- Myocardial Infarction
- Being tested
- CAP-1002 Allogeneic Cardiosphere-Derived Cells, Placebo
- Keywords
- Myocardial Infarction, Heart Attack, Stem cell, Left ventricular dysfunction, Congestive heart failure
- Medical subject headings
- Myocardial Infarction, Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP-1002 Allogeneic Cardiosphere-Derived CellsBiological
Single dose, blinded, intracoronary infusion of 25 Million cardiosphere-derived cells
PlaceboDrug
Single, blinded, intracoronary infusion of a placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CAP-1002 Allogeneic Cardiosphere-Derived Cells | Active comparator | Not described Receives: Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Any of the Adjudicated Events
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).
Measured: Within 1-month post-infusion
Percent Change From Baseline in Myocardium Mass Infarct Size at 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%.
Measured: Baseline, Month 12
Secondary outcomes (22)
Number of Participants Experiencing Any of the Adjudicated Events
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.
Measured: Up to Month 12 post-infusion
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 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%.
Measured: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 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%.
Measured: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 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%.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12
Infarct size in grams was assessed by magnetic resonance imaging. Absolute change was calculated as: post-baseline value-Baseline value.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 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%.
Measured: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Viable Mass at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Viable Mass at Month 6 and12
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%.
Measured: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 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%.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Six-Minute Walk Test at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 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.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12
NT-proBNP was the cardiac biomarkers assessed through serum sample.
Measured: Baseline, Month 6 and Month 12
Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12
NT-proBNP was the cardiac biomarkers assessed through serum sample.
Measured: Baseline, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study start13 Nov 2012
- Primary completion3 Jul 2017
- Study completion28 Feb 2019
Why it stopped: On February 28, 2019, Capricor ceased ongoing follow-up activities and terminated the ALLSTAR trial to focus resourcing on its active CAP-1002 program, HOPE-2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capricor Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Frank Litvack, MD, Study director, Capricor Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458405
- Sponsor's protocol ID
- 1002-01
- Other IDs
- RC3HL103356-01
- Acronym
- ALLSTAR
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2011
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ostovaneh MR, Makkar RR, Ambale-Venkatesh B, Ascheim D, Chakravarty T, Henry TD, Kowalchuk G, Aguirre FV, Kereiakes DJ, Povsic TJ, Schatz R, Traverse JH, Pogoda J, Smith RD, Marban L, Marban E, Lima JAC. Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial. Open Heart. 2021 Jul;8(2):e001614. doi: 10.1136/openhrt-2021-001614.
PubMed 34233913Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marban L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marban E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2020 Sep 21;41(36):3451-3458. doi: 10.1093/eurheartj/ehaa541.
PubMed 32749459
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT01458405
- Acronym / sponsor ID
- ALLSTAR / 1002-01
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Heart Attack, Stem cell, Left ventricular dysfunction, Congestive heart failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On February 28, 2019, Capricor ceased ongoing follow-up activities and terminated the ALLSTAR trial to focus resourcing on its active CAP-1002 program, HOPE-2.
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Capricor Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), California Institute for Regenerative Medicine (CIRM)
- Study start
- 13 Nov 2012 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CAP-1002 Allogeneic Cardiosphere-Derived Cells | Active comparator | Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or Creatine phosphokinase MB isoenzyme (CK-MB) >5 times the upper limit of normal. Also at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
- History of percutaneous coronary intervention (PCI), with stent placement resulting in Thrombolysis in Myocardial Infarction (TIMI) flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
- At least one assessment of left ventricular ejection function (LVEF) <=0.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period.
- Note: participants may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.
- Left ventricular infarct size of >= 15% of left ventricular mass in the qualifying infarct-related region to be infused as determined by centrally read screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the infarcted regions.
Key exclusion criteria (30 listed)
- Participants with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.
- Diagnosed or suspected myocarditis.
- History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
- History of acute coronary syndrome in the 4 weeks prior to study infusion.
- History of previous stem cell therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAP-1002 Allogeneic Cardiosphere-Derived CellsSingle dose, blinded, intracoronary infusion of 25 Million cardiosphere-derived cells | Biological | CAP-1002 Allogeneic Cardiosphere-Derived Cells |
| PlaceboSingle, blinded, intracoronary infusion of a placebo solution | Drug | Placebo |
Primary outcome
Number of Participants Experiencing Any of the Adjudicated Events
Time frame: 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
Time frame: 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%.
22 secondary outcomes
Number of Participants Experiencing Any of the Adjudicated Events
Time frame: Up to Month 12 post-infusion
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Viable Mass at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Viable Mass at Month 6 and12
Time frame: Baseline, Month 6 and Month 12
Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Six-Minute Walk Test at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12
Time frame: Baseline, Month 6 and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34233913Ostovaneh MR, Makkar RR, Ambale-Venkatesh B, Ascheim D, Chakravarty T, Henry TD, Kowalchuk G, Aguirre FV, Kereiakes DJ, Povsic TJ, Schatz R, Traverse JH, Pogoda J, Smith RD, Marban L, Marban E, Lima JAC. Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial. Open Heart. 2021 Jul;8(2):e001614. doi: 10.1136/openhrt-2021-001614.
- Derived from this study: PubMed 32749459Makkar RR, Kereiakes DJ, Aguirre F, Kowalchuk G, Chakravarty T, Malliaras K, Francis GS, Povsic TJ, Schatz R, Traverse JH, Pogoda JM, Smith RR, Marban L, Ascheim DD, Ostovaneh MR, Lima JAC, DeMaria A, Marban E, Henry TD. Intracoronary ALLogeneic heart STem cells to Achieve myocardial Regeneration (ALLSTAR): a randomized, placebo-controlled, double-blinded trial. Eur Heart J. 2020 Sep 21;41(36):3451-3458. doi: 10.1093/eurheartj/ehaa541.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Litvack, MD study director
Capricor Inc.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAP-1002 Allogeneic Cardiosphere-Derived Cells in people with Myocardial Infarction, run by Capricor Inc. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Any of the Adjudicated Events (time frame: Within 1-month post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.