Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction

ConditionChronic Ischemic Left Ventricular Dysfunction

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age21-80

SponsorJoseph C. Wu

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells
Drug
50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells
Drug
150M cells delivered in a dose of 15M cells per injection over 10 injections
Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
Drug
300M cells delivered in a dose of 30M per injection over 10 injections

Treatment groups

18 Participants

are divided into 3 treatment groups

Group A: Cohort 1Active comparator 1 intervention

Group B: Cohort 2Active comparator 1 intervention

Group C: Cohort 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs)

The primary endpoints are safety and feasibility. The feasibility of preparing and delivering the study product, as well as collecting cardiac MRI variables in subjects will be assessed.

Time frame

3 Years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joseph C. Wu

Lead sponsor

Stanford University

Sponsor institution

California Institute for Regenerative Medicine (CIRM)

Collaborator

Source ClinicalTrials.gov

Apply now