Actively Recruiting

Phase 1
Age: 21Years - 80Years
All Genders
NCT05068674

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

Led by Joseph C. Wu · Updated on 2025-09-29

18

Participants Needed

1

Research Sites

340 weeks

Total Duration

On this page

Sponsors

J

Joseph C. Wu

Lead Sponsor

C

California Institute for Regenerative Medicine (CIRM)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 21 to under 80 years old.
  • Provide written informed consent.
  • Have chronic ischemic left ventricular dysfunction secondary to myocardial infarction confirmed by imaging.
  • Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
  • Have stable treatment with beta-blockers for at least 3 months.
  • Have stable treatment with ACE inhibitors, ARBs, or ARNIs for at least 1 month or appropriate medical indication if not used.
  • Have left ventricular ejection fraction below 40%.
  • Have Class II or III NYHA heart failure symptoms within 6 months before baseline.
  • Have hospitalization in past 6 months or elevated NT pro-BNP levels.
  • Have an automated implantable cardioverter-defibrillator (AICD) in place.
Not Eligible

You will not qualify if you...

  • Have a baseline glomerular filtration rate below 35 ml/min/1.73 m2.
  • Have serious radiographic contrast allergy.
  • Have prosthetic aortic valve or heart constrictive device.
  • Have aortic stenosis with valve area 1.5 cm2 or less.
  • Have moderate to severe aortic insufficiency graded as 2 or higher.
  • Have life-threatening arrhythmia without a defibrillator or QTc interval over 550 ms.
  • Have had AICD firing in past 60 days.
  • Be eligible for or require coronary artery revascularization.
  • Have hematologic abnormalities (low hematocrit, white blood cells, or platelets) without other cause.
  • Have liver dysfunction with enzymes three times above normal.
  • Have coagulopathy with INR over 1.3 not reversible.
  • Be allergic to penicillin or streptomycin.
  • Be an organ transplant recipient or have history of transplant rejection.
  • Have cancer within past 5 years except certain treated skin or cervical cancers.
  • Have non-cardiac illness limiting lifespan to under 1 year.
  • Be on chronic immunosuppressant therapy.
  • Be positive for HIV, hepatitis B or active hepatitis C.
  • Be participating in another investigational trial within past 30 days.
  • Be pregnant, nursing, or a woman of childbearing potential not using effective birth control.
  • Tested positive for COVID-19 within last 30 days.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stanford Hospital and Clinics

Palo Alto, California, United States, 94305

Actively Recruiting

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Research Team

J

Joseph C. Wu, MD, PhD

CONTACT

E

Evgenios Neofytou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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