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Table 2 Overview of clinical study details

From: Safety and efficacy of cell therapies in pediatric heart disease: a systematic review and meta-analysis

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
  1. HLHS hypoplastic left heart syndrome, SV single ventricle, DCM dilated cardiomyopathy, DNR did not report
  2. aAbsolute cell count
  3. bDose obtained based on additional study cited within paper