Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Hypoplastic Left Heart Syndrome

In brief

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.

Key facts

Study ID

NCT02398604

Run by

Longeveron Inc.

People needed

5

Starts

2015-04-01

Expected to finish

2019-03-01

Last updated by the study team

2021-07-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with hypoplastic left heart syndrome (all types) requiring BDCPA surgery.

You may not qualify if…

• 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.

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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