TerminatedPhase 1

Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

Stopped: Study was closed due to Sponsor switched to Longeveron. New Identifier is NTC03525418

United States5 participantsStarted 2015-04

Plain-language summary

This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.

Who can participate

Age range

30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with hypoplastic left heart syndrome (all types) requiring BDCPA surgery. Exclusion Criteria: * Have HLHS and restrictive or intact atrial septum. * Be undergoing the Norwood procedure that do not have HLHS. * Have significant coronary artery sinusoids. * Require mechanical circulatory support prior to surgery. * Have an underlying evidence of arrhythmia requiring anti-arrhythmia therapy. * Parent or guardian unwilling or unable to comply with necessary follow-up(s) * Be serum positive for HIV, hepatitis BsAg (B Surface Antigen) or viremic hepatitis C. * Be unsuitable for inclusion in the study, in the opinion of the investigator. * Need for concomitant surgery for aortic coarctation or tricuspid valve repair.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Monitor major adverse cardiac events

Timeframe: 1 month after injection

Trial details

NCT IDNCT02398604

SponsorLongeveron Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03

View on ClinicalTrials.gov More Hypoplastic Left Heart Syndrome trials

Who can participate

Age range

30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.