Table 2 Overview of clinical study details
Author (year) | Study design | Human characteristics | Intervention characteristics | Outcome measures | |||
|---|---|---|---|---|---|---|---|
Study type | Disease | Age | Cell type; source (origin) | Total dose (cells/kg); route; timing of delivery; frequency | Timing of assessment | Ventricular function mode of assessment | |
Burkhart et al. [21] | Case report | HLHS | 4 months | Umbilical cord blood (autologous) | 3.0 × 106; intramyocardial; at time of stage II palliation; once | Baseline and 3 months | Echo |
Burkhart et al. [22] | Phase I | HLHS | 3–6 months | Umbilical cord blood (autologous) | 3.0 × 106; intramyocardial; during stage II palliation; once | Baseline, discharge, 1 month, 3 months, and 6 months | Echo |
Eitoku et al. [23] | Phase I/II | SV | 5–70 months | Cardiac (autologous) | 3.0 × 105; intracoronary; 1-month post-staged palliation; once | Baseline, 3 years | Cardiac MRI |
Ishigami et al. (2014) | Phase I | HLHS | 1.5 years | Cardiac (autologous) | 3.0 × 105; intracoronary; 1-month post-staged palliation; once | Baseline, 3 months, 6 months, 12 months, and 18 months | Echo, cardiac MRI |
Ishigami et al. [24] | Phase II | SV | 1.2–4.2 years | Cardiac (autologous) | 3.0 × 105; intracoronary; 1-month post-staged palliation; once | Baseline, 3 months | Cardiac MRI |
Pincott et al. [25] | Phase I/II | DCM | 1–16 years | Bone marrow (autologous) | 5.4 × 107b; intracoronary; within 1 h of harvest; once | Baseline, 6 moths | Cardiac MRI, Cath |
Qureshi et al. [26] | Case report | HLHS | 25 years | Bone marrow (autologous) | 2.0 × 106; intracoronary; within 3 h of harvest; once | Baseline, 1 month, 3 months, 6 months | Echo |
Rivas et al. [27] | Case report | DCM | 3–4 months | Bone marrow (autologous) | 8.35 × 106a; intracoronary; 2 h post-isolation; once | Baseline, 1 week, 4 weeks, 8 weeks, and 17 weeks | Echo |
Rupp et al. [28] | Case report | HLHS | 11 months | Bone marrow (autologous) | DNR; intracoronary; day of harvest; once | Baseline, 3 months | Echo, cardiac MRI |
Rupp et al. [29] | Phase I/II | DCM | 4 months-16 years | Bone marrow (autologous) | DNR; intracoronary; day of harvest; once | Baseline, 2–3 months, 24–52 months | DNR |
Sano et al. [30] | Phase I | SV | 8 months-3.1 years | Cardiac (autologous) | 3.0 × 105; intracoronary; intraoperative (stage II or III); once | Baseline, 1 year, 2 years post-palliation | Echo |
Tarui et al. [31] | Phase I | HLHS | 1.5 years | Cardiac (autologous) | 3.0 × 105; intracoronary; 1-month post-staged palliation; once | Baseline, 36 months | Cardiac MRI |
Zschirnt et al. [32] | Case report | DCM | DNR | Bone marrow (autologous) | 2.4 × 107; intracoronary; DNR; once | Baseline, 4 months | Cardiac MRI |