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iPSC-CL for Congenital Heart Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are currently struggling with alcohol or drug abuse, which could prevent you from getting a heart transplant.I have had cancer in the past.You have depression that is not being managed or controlled.I understand the study and can give my consent.I cannot have anesthesia due to health reasons.You were not able to get a heart transplant because of social reasons.My heart pumps well but still fails.My BMI is over 30, indicating obesity.I am currently being treated for an infection.I have a heart condition where I was born with only one ventricle.You have tested positive for HIV, Hepatitis B, Hepatitis C, or Syphilis.Your heart's QTc measurement is more than 500 milliseconds.My kidney disease is at stage III or more advanced.You are not suitable for wearing a LifeVest defibrillator.I have had heart rhythm problems that needed treatment.I have a history of liver cirrhosis.My diabetes is not well-managed.I cannot take amiodarone for the next 3 months.I am on the US heart transplant list but may not receive a heart in time.You have a support system that helps you attend all required tests and procedures for the study, and helps you follow the study requirements for a long time.I have been on the best standard treatment for my condition for at least 3 months.You have had a heart transplant in the past.I am between 18 and 40 years old.Your doctor expects you to live for 1 to 1.5 more years when you have the skin biopsy.You have been told you cannot get a heart transplant at a recognized US hospital.You have a history of not following the rules or instructions.I do not have my own iPSC-CL available for treatment.I have a history of heart artery disease.My heart failure is caused by another health condition like amyloidosis.I cannot have someone with me 24/7 for the first 3 weeks after treatment.I have severe heart failure with poor heart pumping function.You are currently using or planning to use a mechanical device as a long-term treatment.
- Group 1: Treated
- Group 2: Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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