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Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)

Primary Objective

This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation.

Study category: Heart and Blood Conditions

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Description

Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery.

Details
Age

Child

Eligibility

Subjects less than 9 months of age with HLHS or HLHS variant who are scheduled to undergo Stage II surgical palliation (Glenn surgery)

Detailed Eligibility: 1. Child that participated in the UCB Collection protocol with autologous UCB-MNC product that is acceptable for use (treatment arm only). 2. Child with HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and Stage II surgical repair. 3. Child is < 9 months of age.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Scope

National

Location

Childrens Hospital Colorado

Principal Investigator
James Jaggers

James Jaggers

Study ID

Protocol Number: 18-2012

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