Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome (AutoCell-S2)



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:April 2019
End Date:February 2026
Contact:Sarah Hanson
Email:sarah@regentheranostics.com
Phone:507-272-3835

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Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)

Researchers want to better understand what happens to the heart when the stem cells are
injected directly into the muscle of the right side of the heart during the Stage II
palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS)
or HLHS variant. Researchers want to see if there are changes in the heart's
structure/function following this stem cell-based therapy and compared to children that have
not had cell-based therapy.

This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into
the myocardium of the right ventricle of the heart at the time of Stage II surgical repair
will provide an improvement in cardiac function, reaching growth and developmental
milestones, and quality of life, while also providing a reduction in the cumulative days of
hospitalization following Stage II surgical repair. Long-term improvement in cardiac
function, reaching growth and developmental milestones, reaching Stage III surgical repair
pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of
life will also be determined.

Inclusion Criteria:

- Child that participated in the UCB Collection protocol with autologous UCB-MNC product
that is acceptable for use (treatment arm only).

- Child with HLHS or HLHS variant with single right ventricular dependent CHD having
undergone Stage I surgical repair and Stage II surgical repair.

- Child is < 9 months of age.

Exclusion Criteria:

- History of DMSO reaction for either the child or mother (treatment arm only).

- Parent(s) and/or guardian(s) unwilling to have their child participate or unwilling to
follow the study procedures.

- Child with severe chronic diseases at the discretion of the treating physician.

- Extensive extra-cardiac syndromic features.

- Known history of cancer.

- Child with the following complications of their congenital heart disease:

1. Any condition requiring urgent, or unplanned procedure within 15 days prior to
Stage II surgical repair, unless complete and full cardiac recovery is documented
by site investigator

2. Severe pulmonary hypertension (reported in the medical record as >70% systemic
pressure)

3. Other clinical concerns as documented by a site investigator that would predict
(more likely to happen than not to happen) a risk of severe complications or very
poor outcome during or after Stage II surgical repair.
We found this trial at
6
sites
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Ram Kuma Subramanyan, M.D.
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Joseph W Rossano, M.D.
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: James Jaggers, M.D.
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Minneapolis, Minnesota 55404
Principal Investigator: David M Overman, M.D.
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Minneapolis, MN
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Oklahoma City, Oklahoma 73104
Principal Investigator: Harold M Burkhart, M.D.
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Oklahoma City, OK
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Rochester, Minnesota 55905
Principal Investigator: Frank Cetta, MD
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Rochester, MN
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