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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05068674 on ClinicalTrials.gov