Status:
COMPLETED
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
Lead Sponsor:
Timothy J Nelson, MD, PhD
Collaborating Sponsors:
University of Oklahoma
Children's Hospital of Philadelphia
Conditions:
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children...
Detailed Description
This study is a Phase I trial to determine the safety of autologous mononuclear cells (MNC) derived from umbilical cord blood for intramyocardial delivery into the right ventricle during a planned and...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Individuals with autologous cord blood product that met all cell release criteria (listed on the certificate of analysis from Mayo Clinic Human Cell Therapy Lab) as follows:
- No aerobic or anaerobic bacterial growth after 14 days
- Greater than 70% cell viability pre-freeze
- Total Nucleated Cells (TNC) concentration of 30-42 x 106 cells/mL (pre-freeze)
- Minimum of one (1) vial of cells
- Mononuclear cell percentage of greater than 50%
- Endotoxin result of less than 16 Endotoxin Units (EU)/mL.
- Mother's serology test results are negative for HIV, Hepatitis B, and Hepatitis C.
- Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glenn surgery.
- Ages up to 18 months are eligible if written informed consent can be obtained from both parents (unless one parent is not reasonably available) and/or legal guardians.
- Exclusion Criteria
- Child who's UCB does not meet the specified cell release criteria in Inclusion Criterion #1.
- History of dimethyl sulfoxide (DMSO) reaction for either the child or mother.
- Parent(s)/child unwilling to participate.
- Child with severe chronic diseases, extensive extra-cardiac syndromic features, or history of cancer.
- Child not completing all pre-procedure work-up within 10 days of the Stage II Glenn surgery as listed in section 6 of this protocol AND lack of pre-procedure work-up documented as a safety concern by a site investigator.
- Child who's cells have been compromised after meeting cell release criteria (as defined in Inclusion Criterion #1).
- Child with the following complications of their congenital heart disease:
- Any condition requiring urgent, or unplanned procedure within 15 days prior to Stage II surgical repair
- Severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure)
- 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.
Exclusion
Key Trial Info
Start Date :
May 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01883076
Start Date
May 15 2013
End Date
April 28 2021
Last Update
April 29 2022
Active Locations (6)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States, 55404
4
Mayo Clinic
Rochester, Minnesota, United States, 55905