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Stem Cell Therapy

iPSC-CL for Congenital Heart Disease

Phase 1
Recruiting
Research Sponsored by HeartWorks, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be able to understand and provide informed consent
Univentricular congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial aims to test if lab-grown heart cells, made from stem cells, are safe and feasible to use to treat people with congenital heart disease. Participants must agree to testing and monitoring before and after product administration, and lifelong follow-up.

Who is the study for?
This trial is for adults aged 18-40 with single ventricle congenital heart disease, class IV heart failure, and an ejection fraction below 40%. They must have maximized all treatments, be ineligible or waiting for a heart transplant, possibly on mechanical support, and able to consent. Exclusions include substance abuse, active infections, uncontrolled depression or other conditions that could risk safety or compliance.Check my eligibility
What is being tested?
The trial tests the safety of lab-grown heart cells (iPSC-CL) in those with congenital heart disease. Participants will receive these cells and undergo monitoring before and after treatment to assess safety and feasibility. The study includes lifelong follow-up comparing treated subjects against untreated ones from the same pool.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with stem cell therapy such as immune reactions, infection risks due to immunosuppression if used, potential for abnormal tissue growth or arrhythmias given the cardiac nature of the cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can give my consent.
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I have a heart condition where I was born with only one ventricle.
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I am on the US heart transplant list but may not receive a heart in time.
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I have been on the best standard treatment for my condition for at least 3 months.
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I am between 18 and 40 years old.
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I have severe heart failure with poor heart pumping function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Feasibility
Short term safety
Secondary outcome measures
Cardiac High Sensitivity Troponin T
Long term safety
NT-pro-BNP
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatedExperimental Treatment1 Intervention
Subjects in Treated arm will receive one dose of Investigational Product. Within this arm are three dose levels. Dose level selection will be determined by product availability subjects have available product and when they can be treated. Dose levels will escalate in order of treatment date.
Group II: ControlActive Control1 Intervention
Subjects who enroll but do not receive Investigational Product will be placed in the control arm.

Find a Location

Who is running the clinical trial?

HeartWorks, Inc.Lead Sponsor
Timothy J Nelson, M.D., Ph.D.Study DirectorHeartWorks, Inc.
2 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

iPSC-CL (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05647213 — Phase 1
Single Ventricle Heart Research Study Groups: Treated, Control
Single Ventricle Heart Clinical Trial 2023: iPSC-CL Highlights & Side Effects. Trial Name: NCT05647213 — Phase 1
iPSC-CL (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647213 — Phase 1

Frequently Asked Questions

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

Does this trial permit the enrollment of participants aged 45 and above?

"This research requires that individuals are between 18 and 40 years old. 121 studies call for minors while 916 seek to include elders in the study."

Answered by AI

What adverse effects may arise from Treated usage?

"Our evaluation of Treated's safety has yielded a score of 1 due to the limited evidence available from this Phase 1 trial."

Answered by AI

Are participants being recruited for this research endeavor?

"As per the information published on clinicaltrials.gov, this medical trial has opened enrollment and is actively seeking participants. This research was initially made available to the public on February 3rd 2023 with its most recent update occurring six days later."

Answered by AI

Who qualifies to participate in this research trial?

"This research is seeking 50 volunteers with single ventricle hearts who are between 18 and 40 years old. In order to qualify, the Principal Investigator must determine that they meet the criteria at least 9 months after skin punch biopsy procedure has been performed."

Answered by AI

What objectives does this research endeavor hope to realize?

"The goal of this evaluation, which will span a 3 month duration, is to observe the feasibility of its intervention. Specific outcomes include changes in tumor marker levels (PSA (males only), CA 125, CEA, CA 19-9, alpha fetoprotein (AFP), CA 195 and Alpha Subunit HCG) at 3 months post treatment and annually afterwards; PRA levels at both 3 and 12 months after delivery; as well as cardiac high sensitivity troponin T at three hours plus or minus thirty minutes following delivery and one month post surgery compared to the control group."

Answered by AI

How many individuals are currently receiving treatment as part of this experiment?

"Affirmative. According to clinicaltrials.gov, this research trial is presently enrolling participants and was initially published on March 2nd 2023 with its last update taking place a week later. A total of 50 patients are required from one medical facility."

Answered by AI
~31 spots leftby Feb 2026