Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction
NCT05068674 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-09-29
Summary
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).
Conditions
- Chronic Ischemic Left Ventricular Dysfunction
Interventions
- DRUG
-
Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells
50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
- DRUG
-
Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells
150M cells delivered in a dose of 15M cells per injection over 10 injections
- DRUG
-
Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells
300M cells delivered in a dose of 30M per injection over 10 injections
Sponsors & Collaborators
-
California Institute for Regenerative Medicine (CIRM)
collaborator OTHER -
Joseph C. Wu
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-22
- Primary Completion
- 2028-10-31
- Completion
- 2028-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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