Stem cells injected into damaged hearts: a new hope?
NCT ID NCT05068674
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether injecting lab-grown heart cells (made from human embryonic stem cells) can safely improve heart function in 18 adults with chronic heart damage from a past heart attack. Participants receive one of three doses via a catheter, and researchers monitor safety and heart imaging for up to a year. The goal is to find a safe dose, not yet to cure the condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 areas of akinesis, dyskinesis, or severe hypokinesis. * 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 beta-blocker for 3 months. For angiotensinconverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical indication precluding use of one or both of these agents, the patient must have been on a stable dose of a clinically appropriate agent for 1 month or within no more than doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months. * 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. Exclusion Criteria: * 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 functioning pacemaker) or QTc interval \> 550 ms on screening ECG. * 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 from Coumadin will be excluded from enrollment. * 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 carcinoma. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford Hospital and Clinics
RECRUITINGPalo Alto, California, 94305, United States