drugset / Trial / NCT01883076
Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
Phase 1
Completed
30 enrolled
Timothy J Nelson, MD, PhD
Children's Hospital Colorado · collabChildren's Hospital Los Angeles · collabChildren's Hospital of Philadelphia · collabChildren's Hospitals and Clinics of Minnesota · collabMayo Clinic · collabUniversity of Oklahoma · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-05-15
- Primary completion
- 2021-04-28
- Completion
- 2021-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | umbilical cord blood derived mononuclear cells | Cell therapy | 3 cells/kg | Other |