Ischemic CardiomyopathyPhase 1RECONSTRUCTNCT01496209
REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts
A Phase 1 study testing Endomyocardial injections of allogeneic Human CSps in people with Ischemic Cardiomyopathy and Chronic Ischemic Cardiomyopathy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy, Chronic Ischemic Cardiomyopathy
- What is being tested?
- Endomyocardial injections of allogeneic Human CSps
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adults with ischemic cardiomyopathy (EF >10 and <40% by functional imaging [ECHO, CT, MRI, contrast ventriculography])
- Symptomatic heart failure of NYHA Class 2 or 3
- History of prior remote (>3 mo) myocardial infarction and/or documented obstructive coronary artery disease with corresponding dysfunctional segments by functional imaging
- Age > 18 years
- Ability to provide informed consent and follow-up with protocol procedures
Who cannot join
- Documented myocardial infarction within 3 months (120 days)
- Known or suspected left ventricular thrombus
- Non-cardiovascular disease with life expectancy of < 3 years
- Absence of significant gadolinium-enhanced scar (>10% of LV mass) at baseline MRIc
- Positive panel-reactive antibodies (PRA)
- Need for further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial. This will be determined by a cardiologist who is not an investigator in the clinical trial. No further revascularization may be indicated by no arteries with significant stenosis, the location, and extent of any stenosis may not be suitable for angioplasty, the distal vessels may not be suitable for placement of bypass grafts, and/or the patient declines angioplasty or bypass surgery.
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- NYHA IV heart failure
- History of aortic stenosis/insufficiency
- Requirement for chronic immunosuppressive therapy
- Participation in an on-going protocol studying an experimental drug or device
- Diagnosis of congenital or genetically-transmitted cardiomyopathy
- Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures
- Pregnancy or child-bearing potential without use of effective contraception. Men intending to "father" children are also excluded.
- Human Immunodeficiency virus infection
- Viral hepatitis
- Uncontrolled diabetes and/or hemoglobin A1C > 8.5%
- Abnormal liver function (SGPT > 3 times the upper reference range) and/or hematology (hematocrit <25%, WBC <3000, Platelets <100,000) studies without a reversible, identifiable cause
- Ventricular tachycardia or fibrillation not associated with an acute ischemic episode
- Canadian Cardiovascular Society Angina Class 3 or 4
- History of cardiac tumor or cardiac tumor demonstrated or suspected on MRI other imaging modality
- Previous stem cell therapy/treatment
- Individuals who are not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.
- Being tested
- Endomyocardial injections of allogeneic Human CSps, Endomyocardial injections of vehicle only.
- Keywords
- Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Disease, Cardiovascular Disease, Chronic Ischemia
- Medical subject headings
- Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomyocardial injections of allogeneic Human CSpsBiological
Also called Biological: Allogeneic Human CSps (or alloCSps)
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
Endomyocardial injections of vehicle only.Biological
NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Sham comparator | Not described Receives: Biological: Endomyocardial injections of vehicle only. |
| Group: Cardiosphere Treatment | Experimental | Biological: Allogeneic Human Cardiospheres (allogeneic CSps or alloCSps), a 3D micro-tissue heart-derived cell therapy product. Subjects will receive 150 million cell-equivalents of alloCSps via endomyocardial injection (10 million per site at 15 peri-infarct sites) Receives: Biological: Endomyocardial injections of allogeneic Human CSps |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJul 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Marban, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Eduardo Marban, MD, PhD, Principal investigator, Cedars-Sinai Medical Center, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496209
- Sponsor's protocol ID
- RECONSTRUCT
- Acronym
- RECONSTRUCT
- Status last verified
- Feb 2014
- First submitted
- 19 Dec 2011
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts
- ClinicalTrials.gov ID
- NCT01496209
- Acronym / sponsor ID
- RECONSTRUCT / RECONSTRUCT
- Keywords
- Infarction, Myocardial Infarction, Ventricular Dysfunction, Left, Heart Disease, Cardiovascular Disease, Chronic Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Sham comparator | Biological: Endomyocardial injections of vehicle only. |
| Group: Cardiosphere Treatment | Experimental | Biological: Endomyocardial injections of allogeneic Human CSpsBiological: Allogeneic Human Cardiospheres (allogeneic CSps or alloCSps), a 3D micro-tissue heart-derived cell therapy product. Subjects will receive 150 million cell-equivalents of alloCSps via endomyocardial injection (10 million per site at 15 peri-infarct sites) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with ischemic cardiomyopathy (EF >10 and <40% by functional imaging [ECHO, CT, MRI, contrast ventriculography])
- Symptomatic heart failure of NYHA Class 2 or 3
- History of prior remote (>3 mo) myocardial infarction and/or documented obstructive coronary artery disease with corresponding dysfunctional segments by functional imaging
- Age > 18 years
- Ability to provide informed consent and follow-up with protocol procedures
Key exclusion criteria (22 listed)
- Documented myocardial infarction within 3 months (120 days)
- Known or suspected left ventricular thrombus
- Non-cardiovascular disease with life expectancy of < 3 years
- Absence of significant gadolinium-enhanced scar (>10% of LV mass) at baseline MRIc
- Positive panel-reactive antibodies (PRA)
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 |
|---|---|---|
| Endomyocardial injections of allogeneic Human CSpsAlso: Biological: Allogeneic Human CSps (or alloCSps)NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps. | Biological | Group: Cardiosphere Treatment |
| Endomyocardial injections of vehicle only.NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo. | Biological | Placebo control |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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.
Eduardo Marban, MD, PhD principal investigator
Cedars-Sinai Medical Center, Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endomyocardial injections of allogeneic Human CSps in people with Ischemic Cardiomyopathy and Chronic Ischemic Cardiomyopathy, run by Cedars-Sinai Medical Center at 1 site 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 5 inclusion and 22 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: withdrawn, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 12 Feb 2014.