Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic 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
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
Treatments tested in this trial
- Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells
- Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells
- Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Joseph C. Wu
Lead sponsor
Stanford University
Sponsor institution
California Institute for Regenerative Medicine (CIRM)
Collaborator
Source ClinicalTrials.gov