Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syn… (NCT01883076) | Clinical Trial Compass
CompletedPhase 1
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
United States30 participantsStarted 2013-05-15
Plain-language 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 undergoing a scheduled Glenn surgical procedure.
The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.
Who can participate
Age range18 Months
SexALL
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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.
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.
What they're measuring
1
Incidence of all-cause mortality
Timeframe: Within 2 years following cell therapy treatment
2
Incidence of new and worsening adverse cardiac events
Timeframe: Within 2 years following cell therapy treatment
3
Percentage of subjects whose cells meet all cell release criteria
Timeframe: Up to 2 years
4
Percentage of subjects enrolled who undergo cell therapy treatment
✕. 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