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New treatment option for Chronic Ischemic Left Ventricular Dysfunction
Official title Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction
ClinicalTrials.gov ID: NCT05068674
What this study is testing
What is Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells?
Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic ischemic left ventricular dysfunction.
Also referred to as Human ESC-CMs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- Be ≥ 21 and \< 80 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an...
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the...
You likely can't join if
- Have a baseline glomerular filtration rate \< 35 ml/min/1.73 m2
- Have a known, serious radiographic contrast allergy.
- Have a prosthetic aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- Have evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or...
See the full eligibility criteria
- Be ≥ 21 and \< 80 years of age.
- Provide written informed consent.
- Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as defined by previous myocardial infarction documented by an imaging study demonstrating coronary artery disease with corresponding...
- Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
- Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate...
- Left ventricular ejection fraction below 40%.
- Class II/III NYHA symptoms of heart failure within the 6 months prior to baseline testing.
- Hospitalization in the past 6 months or NT pro-BNP \> 1200 pg/mL, or \>1600 pg/mL if atrial fibrillation was present.
- Automated implantable cardioverter-defibrillator (AICD) in place.
- Have a baseline glomerular filtration rate \< 35 ml/min/1.73 m2
- Have a known, serious radiographic contrast allergy.
- Have a prosthetic aortic valve or heart constrictive device.
- Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or less).
- Have a documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- Have evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second- or third-degree heart block in the absence of a...
- AICD firing in the past 60 days prior to enrollment.
- Be eligible for or require coronary artery revascularization.
- Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/µl, or platelet values \< 100,000/µl 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...
- Have known allergies to penicillin or streptomycin.
- Be an organ transplant recipient.
- Have a history of organ or cell transplant rejection.
- 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...
- Have a non-cardiac condition that limits lifespan to \< 1 year.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum-positive for HIV, hepatitis BsAg, or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be a female patient who is pregnant, nursing, or have child-bearing potential but is not using effective birth control.
- Tested positive for SARS-CoV-2 within the last 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.