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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%
Have been treated with appropriate maximal medical therapy for heart failure or postinfarction left ventricular dysfunction. For beta-blockade, the patient must have been on a stable dose of a clinically appropriate beta-blocker for 3 months. For angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical indication precluding use of one or both of these agents, the patient must have been on a stable dose of a clinically appropriate agent for 1 month or within no more than doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

HECTOR Trial 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.Check my eligibility
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.See study design
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.

HECTOR Trial 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 have been on stable heart failure medication for the required time.
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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 scheduled for a heart catheterization procedure within 5 to 10 weeks.
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I have experienced moderate to severe heart failure symptoms in the last 6 months.
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I am between 21 and 79 years old.

HECTOR Trial 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

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

HECTOR 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
63 Previous Clinical Trials
3,136 Total Patients Enrolled

Media Library

Human Embryonic Stem Cell-Derived Cardiomyocyte (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05068674 — Phase 1
Left Ventricular Dysfunction Research Study Groups: Cohort 2, Cohort 3, Cohort 1
Left Ventricular Dysfunction 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria of this clinical experiment extend to individuals aged 70 and above?

"Participants must fall within the 21-80 age range to be eligible for this clinical trial. Simultaneously, 35 and 410 trials are available respectively for those under 18 or over 65 years old."

Answered by AI

Is the recruitment stage of this study still open?

"Affirmative. As per the information listed on clinicaltrials.gov, this research endeavour is actively seeking participants. It was first published in March 22nd 2022 and has since been amended as of September 15th 2022; 18 individuals are required from a single medical site for completion."

Answered by AI

Has the FDA sanctioned Cohort 3 for use in medical treatments?

"An assessment of Cohort 3's safety has been rated 1 due to the scarcity of evidence supporting its efficacy and security as this is an initial phase trial."

Answered by AI

How many subjects are eligible for inclusion in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial is still recruiting participants. Published initially on March 22nd 2022 and modified most recently on September 15th 2022, this research requires 18 volunteers from a single medical centre."

Answered by AI

Who fulfills the criteria necessary to partake in this research?

"The ischemia trial has an age restriction of 21 to 80 and requires 18 volunteers. Those wishing to enrol must meet these requirements in order to be accepted."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford Hospital and Clinics
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Stanford Hospital and Clinics: < 48 hours
~8 spots leftby Oct 2025