Chronic Ischemic Left Ventricular DysfunctionPhase 1/2TAC-HFT-IINCT02503280
The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial.
A Phase 1/2 study testing Autologous hMSCs, Autologous Human C-Kit CSCs II and Biosense Webster MyoStar NOGA Injection Catheter System in people with Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction, run by Joshua M Hare at 1 site in United States.
Trial summary
Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Chronic Ischemic Left Ventricular Dysfunction, Myocardial Infarction
- What is being tested?
- Autologous hMSCs, Autologous Human C-Kit CSCs II and Biosense Webster MyoStar NOGA Injection Catheter System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Mar 2032
- Phase
- Phase 1/2
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, a patient MUST:
- Be ≥ 21 and < 90 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by the following: Screening MRI must show an area of akinesis, dyskinesis, or severe hypokinesis associated with evidence of myocardial scarring based on delayed hyperenhancement following gadolinium infusion.
- Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensin-converting enzyme inhibition, the patient must have been on a stable dose of a clinically appropriate agent for 1 month.
- Be a candidate for cardiac catheterization.
- Have an ejection fraction ≤ 50% by gated blood pool scan, two-dimensional echocardiogram, cardiac MRI, or left ventriculogram within the prior six months and not in the setting of a recent ischemic event.
Who cannot join
- In order to participate in this study, a patient MUST NOT:
- Have a baseline glomerular filtration rate < 50 ml/min1.73m2.
- Have a known, serious radiographic contrast allergy.
- Have a mechanical aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as ≥ +2 equivalent to an orifice area of 1.5cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
Show all 23Show fewer
- Require coronary artery revascularization. Patients who require or undergo revascularization procedures should undergo these procedures a minimum of 3 months in advance of treatment within this study. In addition, patients who develop a need for revascularization following enrollment will be submitted for this therapy without delay.
- Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval > 550 ms on screening ECG.
- AICD firing in the past 60 days prior to the procedure.
- Have unstable angina within 2 weeks of the planned procedure.
- Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation.
- Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Have a coagulopathy = (INR > 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment
- Have known allergies to penicillin or streptomycin.
- Have a contra-indication to performance of an MRI scan.
- Be an organ transplant recipient.
- Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum positive for HIV, hepatitis BsAg or hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the Combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board.
Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.
Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.
Read the detailed description
A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase.
Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization.
- Being tested
- Autologous hMSCs, Autologous Human C-Kit CSCs II, Placebo, Biosense Webster MyoStar NOGA Injection Catheter System
- Keywords
- Cardiovascular, Secondary
- Medical subject headings
- Myocardial Infarction, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hMSCsDrug
Also called Autologous Human Mesenchymal Stem Cells (hMSCs)
Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10^8 (200 million) hMSCs.
Autologous Human C-Kit CSCs IIDrug
Also called Autologous Human C-Kit Cardiac Stem Cells (CSCs) II
Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10^8 (199 million) hMSCs and 1 million C-Kit hCSCs.
PlaceboDrug
Placebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]).
Biosense Webster MyoStar NOGA Injection Catheter SystemDevice
Also called NOGA
Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
| Study group | Role | What they receive |
|---|---|---|
| Group A - Autologous hMSCs | Experimental | Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10^8 (200 million) hMSCs. The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. Receives: Drug: Autologous hMSCs; Device: Biosense Webster MyoStar NOGA Injection Catheter System |
| Group B - Autologous Human C-Kit CSCs II | Experimental | Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10^8 (199 million) hMSCs and 1 million C-Kit hCSCs.The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. Receives: Drug: Autologous Human C-Kit CSCs II; Device: Biosense Webster MyoStar NOGA Injection Catheter System |
| Placebo | Placebo comparator | Placebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]).The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. Receives: Drug: Placebo; Device: Biosense Webster MyoStar NOGA Injection Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any treatment emergent serious adverse events (TE-SAEs)
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or atrial fibrillation.
Measured: One Month post-catheterization
Secondary outcomes (22)
Treatment Emergent adverse event rates
Rate of adverse events occurring ad
Measured: At 6 Month and 12 Month visit
Ectopic tissue formation
Ectopic tissue formation (as identified from MRI scans of the chest, abdomen, \& pelvis).
Measured: At 6 Month and 12 Month visit
48-hour ambulatory electrocardiogram (ECG) recordings.
Electrocardiogram (ECG) recordings measured over 48 Hours
Measured: At 6 Month and 12 Month visit
Hematology value changes post-catheterization
Hematology value changes will be observed at the 6 month and 12 month visit post-catheterization.
Measured: At 6 Month and 12 Month visit
Urinalysis results changes post-catheterization
Urinalysis results changes will be observed at the 6 month and 12 month visit post-catheterization.
Measured: At 6 Month and 12 Month visit
Clinical chemistry values post-catheterization
Clinical chemistry value changes will be observed at the 6 month and 12 month visit post-catheterization.
Measured: At 6 Month and 12 Month visit
Pulmonary function
Pulmonary function - forced expiratory volume in 1 second (FEV1) results.
Measured: At 6 Month and 12 Month visit
Serial troponin I values
Serial troponin I values (every 12 hours for first 48 hours post-cardiac catheterization).
Measured: Every 12 hours for the first 48 hours post-cardiac catheterization
Creatine kinase-MB (CK-MB) value changes post-catheterization
CK-MB values (every 12 hours for first 48 hours post-cardiac catheterization).
Measured: Every 12 hours for first 48 hours post-cardiac catheterization
Post-cardiac catheterization echocardiogram.
Echocardiogram performed after cardiac catheterization
Measured: Day 1 Post Echocardiogram
Magnetic resonance imaging (MRI) measures of infarct scar size (ISS)
Document Infarct Scar Size (ISS) via Magnetic Resonance imaging (MRI)
Measured: At 6 Month and 12 Month visit
Echocardiographic measures of infarct scar size (ISS)
Document Infarct Scar Size (ISS) via echocardiographic procedure
Measured: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Left Regional Ventricular Function
Document Left Regional Ventricular Function via Magnetic Resonance imaging (MRI)
Measured: At 6 Month and 12 Month visit
Echocardiographic measures of Left Regional Ventricular Function
Document Left Regional Ventricular Function via echocardiographic procedure
Measured: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Global Ventricular Function
Document Global Ventricular Function via Magnetic Resonance imaging (MRI)
Measured: At 6 Month and 12 Month visit
Echocardiographic measures of Global Ventricular Function
Document Global Ventricular Function via echocardiographic procedure
Measured: At 6 Month and 12 Month visit
Tissue perfusion measured by MRI.
Measure Tissue Perfusion via Magnetic Resonance imaging (MRI)
Measured: At 6 Month and 12 Month visit
Peak oxygen consumption (Peak VO2) (by treadmill determination).
Peak VO2 Oxygen Consumption determined by utilizing treadmill
Measured: At 6 Month and 12 Month visit
Six-minute walk test.
Evaluate Functional Capacity via the Six Minute Walk Test
Measured: At 6 Month and 12 Month visit
New York Heart Association (NYHA) functional class.
Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Measured: At 6 Month and 12 Month visit
Minnesota Living with Heart Failure (MLHF) questionnaire.
Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire
Measured: At 6 Month and 12 Month visit
Incidence of Major Adverse Cardiac Events (MACE)
Incidence of Major Adverse Cardiac Events (MACE), defined as the composite incidence of (1) death, (2) hospitalization for worsening HF, or (3) non-fatal recurrent MI.
Measured: At 6 Month and 12 Month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start1 Mar 2025 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2032 (estimated)
Why it stopped: Study has never enrolled any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic Left Ventricular DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua M Hare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua M Hare, University of Miami
- Investigators
- Joshua M Hare, MD, Principal investigator, ISCI / University of Miami Miller School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503280
- Sponsor's protocol ID
- 20120203
- Acronym
- TAC-HFT-II
- Status last verified
- Oct 2020
- First submitted
- 4 May 2015
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the Combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT02503280
- Acronym / sponsor ID
- TAC-HFT-II / 20120203
- Keywords
- Cardiovascular, Secondary
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has never enrolled any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joshua M HareUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 20 Jul 2015 (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.
Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board.
Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline.
Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.
Detailed description
A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.
A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase.
Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Autologous hMSCs | Experimental | Drug: Autologous hMSCs, Device: Biosense Webster MyoStar NOGA Injection Catheter SystemAutologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10^8 (200 million) hMSCs. The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. |
| Group B - Autologous Human C-Kit CSCs II | Experimental | Drug: Autologous Human C-Kit CSCs II, Device: Biosense Webster MyoStar NOGA Injection Catheter SystemAutologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10^8 (199 million) hMSCs and 1 million C-Kit hCSCs.The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. |
| Placebo | Placebo comparator | Drug: Placebo, Device: Biosense Webster MyoStar NOGA Injection Catheter SystemPlacebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]).The Biosense Webster MyoStar NOGA Injection Catheter System will be used in the delivery of the study drug. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, a patient MUST:
Key exclusion criteria (23 listed)
- In order to participate in this study, a patient MUST NOT:
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 |
|---|---|---|
| Autologous hMSCsAlso: Autologous Human Mesenchymal Stem Cells (hMSCs)Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10^8 (200 million) hMSCs. | Drug | Group A - Autologous hMSCs |
| Autologous Human C-Kit CSCs IIAlso: Autologous Human C-Kit Cardiac Stem Cells (CSCs) IIAutologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10^8 (199 million) hMSCs and 1 million C-Kit hCSCs. | Drug | Group B - Autologous Human C-Kit CSCs II |
| PlaceboPlacebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]). | Drug | Placebo |
| Biosense Webster MyoStar NOGA Injection Catheter SystemAlso: NOGABiosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug | Device | Group A - Autologous hMSCs, Group B - Autologous Human C-Kit CSCs II, Placebo |
Primary outcome
Incidence of any treatment emergent serious adverse events (TE-SAEs)
Time frame: One Month post-catheterization
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or atrial fibrillation.
22 secondary outcomes
Treatment Emergent adverse event rates
Time frame: At 6 Month and 12 Month visit
Ectopic tissue formation
Time frame: At 6 Month and 12 Month visit
48-hour ambulatory electrocardiogram (ECG) recordings.
Time frame: At 6 Month and 12 Month visit
Hematology value changes post-catheterization
Time frame: At 6 Month and 12 Month visit
Urinalysis results changes post-catheterization
Time frame: At 6 Month and 12 Month visit
Clinical chemistry values post-catheterization
Time frame: At 6 Month and 12 Month visit
Pulmonary function
Time frame: At 6 Month and 12 Month visit
Serial troponin I values
Time frame: Every 12 hours for the first 48 hours post-cardiac catheterization
Creatine kinase-MB (CK-MB) value changes post-catheterization
Time frame: Every 12 hours for first 48 hours post-cardiac catheterization
Post-cardiac catheterization echocardiogram.
Time frame: Day 1 Post Echocardiogram
Magnetic resonance imaging (MRI) measures of infarct scar size (ISS)
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of infarct scar size (ISS)
Time frame: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Left Regional Ventricular Function
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of Left Regional Ventricular Function
Time frame: At 6 Month and 12 Month visit
Magnetic resonance imaging (MRI) of Global Ventricular Function
Time frame: At 6 Month and 12 Month visit
Echocardiographic measures of Global Ventricular Function
Time frame: At 6 Month and 12 Month visit
Tissue perfusion measured by MRI.
Time frame: At 6 Month and 12 Month visit
Peak oxygen consumption (Peak VO2) (by treadmill determination).
Time frame: At 6 Month and 12 Month visit
Six-minute walk test.
Time frame: At 6 Month and 12 Month visit
New York Heart Association (NYHA) functional class.
Time frame: At 6 Month and 12 Month visit
Minnesota Living with Heart Failure (MLHF) questionnaire.
Time frame: At 6 Month and 12 Month visit
Incidence of Major Adverse Cardiac Events (MACE)
Time frame: At 6 Month and 12 Month visit
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 22 Oct 2020.
- Interdisciplinary Stem Cell Institute at the University of Miami Miller School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Ischemic Left Ventricular Dysfunction
Not yet recruiting
Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruiting
A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure
Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction
Active, not recruitingPhase 3
Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19
COVID-19 Associated Cardiac Involvement, Remodeling, Left Ventricle
RecruitingPhase 1
Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction
Chronic Ischemic Left Ventricular Dysfunction
Recruiting
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Heart Failure, Left Bundle-Branch Block
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.
Joshua M Hare, MD principal investigator
ISCI / University of Miami Miller School of Medicine
1 site 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 Autologous hMSCs, Autologous Human C-Kit CSCs II and Biosense Webster MyoStar NOGA Injection Catheter System in people with Chronic Ischemic Left Ventricular Dysfunction and Myocardial Infarction, run by Joshua M Hare 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 7 inclusion and 23 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 22 Oct 2020. 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 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?
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.
What does the primary outcome measure?
Incidence of any treatment emergent serious adverse events (TE-SAEs) (time frame: One Month post-catheterization). It is what the study was designed to measure, not a finding.
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 22 Oct 2020.