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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 belowSelect...
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:Select...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that may limit my life to less than a year.I have a serious heart rhythm problem without a pacemaker or defibrillator.I have experienced rejection of a transplanted organ or cells.I need or am eligible for a procedure to improve blood flow to my heart.My blood tests show low levels of hematocrit, white cells, or platelets without a known cause.You have had an AICD (implantable defibrillator) activation within the last 60 days before joining the study.I have received an organ transplant.My heart's pumping ability is reduced.My heart has a narrowed aortic valve of 1.5 cm2 or less.You have tested positive for HIV, hepatitis B, or hepatitis C in your blood.You have a prosthetic aortic valve or a heart constriction device.Your kidneys are not filtering blood well, and the rate is less than 35 ml per minute per 1.73 square meters of body surface area.My heart valve condition is moderate to severe, confirmed by an echo test.My blood does not clot properly, and it's not because I'm taking Coumadin.I have been on stable heart failure medication for the required time.I was hospitalized recently or have high NT pro-BNP levels.My liver enzymes are more than three times the normal limit.I have been cancer-free for 5 years, except for certain skin or cervical cancers.I am on long-term medication to suppress my immune system.I have heart issues due to a past heart attack, confirmed by an imaging study.I am scheduled for a heart catheterization procedure within 5 to 10 weeks.I have experienced moderate to severe heart failure symptoms in the last 6 months.You have a device called an automated implantable cardioverter-defibrillator (AICD) implanted in your body.I am pregnant, nursing, or could become pregnant and am not using birth control.I am between 21 and 79 years old.You are allergic to penicillin or streptomycin.You have a serious allergy to contrast dye used in imaging tests.You have tested positive for COVID-19 in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 3
- Group 3: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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