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Stem Cell Therapy

Stem Cell Therapy for Heart Failure (HECTOR Trial)

Phase 1
Recruiting
Research Sponsored by Joseph C. Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular ejection fraction below 40%
Hospitalization in the past 6 months or NT pro-BNP > 1200 pg/mL, or >1600 pg/mL if atrial fibrillation was present
Must not have
Have a non-cardiac condition that limits lifespan to < 1 year
Have evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second- or third-degree heart block in the absence of a functioning pacemaker) or QTc interval > 550 ms on screening ECG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a new cell therapy (hESC-CMs) to see if it can improve survival and heart function in patients who have chronic left ventricular dysfunction due to MI.

Who is the study for?
Adults aged 21-79 with chronic heart failure due to a past heart attack, who can undergo cardiac catheterization and have been on stable heart medication. They must not have severe allergies, organ transplants, life-limiting non-cardiac conditions, significant kidney/liver/blood issues, or be pregnant. Those with recent serious arrhythmias or certain heart devices are excluded.
What is being tested?
The trial is testing three doses (50M, 150M, and 300M cells) of human embryonic stem cell-derived cardiomyocytes (hESC-CMs) for improving survival and heart function in patients with chronic left ventricular dysfunction after a myocardial infarction.
What are the potential side effects?
Potential side effects may include immune reactions due to the introduction of new cells into the body which could lead to inflammation or rejection symptoms. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is reduced.
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I was hospitalized recently or have high NT pro-BNP levels.
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I have heart issues due to a past heart attack, confirmed by an imaging study.
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I am between 21 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a health condition that may limit my life to less than a year.
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I have a serious heart rhythm problem without a pacemaker or defibrillator.
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My blood does not clot properly, and it's not because I'm taking Coumadin.
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I have experienced rejection of a transplanted organ or cells.
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I need or am eligible for a procedure to improve blood flow to my heart.
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My blood tests show low levels of hematocrit, white cells, or platelets without a known cause.
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I have received an organ transplant.
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My heart has a narrowed aortic valve of 1.5 cm2 or less.
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My heart valve condition is moderate to severe, confirmed by an echo test.
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My liver enzymes are more than three times the normal limit.
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I am on long-term medication to suppress my immune system.
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I am pregnant, nursing, or could become pregnant and am not using birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Cohort 2Active Control1 Intervention
Medium dose (150M cells)
Group II: Cohort 3Active Control1 Intervention
High dose (300M cells)
Group III: Cohort 1Active Control1 Intervention
Low dose (50M cells)

Find a Location

Who is running the clinical trial?

Joseph C. WuLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,340 Total Patients Enrolled

Media Library

Human Embryonic Stem Cell-Derived Cardiomyocyte (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05068674 — Phase 1
Heart Failure Research Study Groups: Cohort 2, Cohort 3, Cohort 1
Heart Failure Clinical Trial 2023: Human Embryonic Stem Cell-Derived Cardiomyocyte Highlights & Side Effects. Trial Name: NCT05068674 — Phase 1
Human Embryonic Stem Cell-Derived Cardiomyocyte (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05068674 — Phase 1
~4 spots leftby Oct 2025
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