UnknownPhase 1/2

Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)

United States10 participantsStarted 2018-02-21

Plain-language summary

This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections

Who can participate

Age range1 Day – 1 Year

SexALL

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Exclusion criteria

✕. Significant coronary artery sinusoids.
✕. Requirement for mechanical circulatory support prior to BDCPA surgery.
✕. Underlying evidence of arrhythmia requiring anti-arrhythmia therapy.
✕. Need for concomitant surgery for aortic coarctation or tricuspid valve repair.
✕. HLHS and restrictive or intact atrial septum.
✕. Undergoing the Stage I (Norwood) procedure that does not have HLHS.
✕. Serum positivity for: HIV; hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV).
✕. Parent/guardian that is unwilling or unable to comply with necessary follow-up.

What they're measuring

Safety: To evaluate the safety and feasibility of intramyocardial injection of LMSCs during the Stage II (BDCPA) operation for HLHS via incidence of Treatment-Emergent Serious Adverse Events.

Timeframe: Evaluated through 1 year post-treatment.

Trial details

NCT IDNCT03525418

SponsorLongeveron Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

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