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Table 4 Elements of external validity

From: Efficacy and safety of regenerative cell therapy for pulmonary arterial hypertension in animal models: a preclinical systematic review protocol

Category Specific items
Strain e.g., Sprague-Dawley versus Fischer 344
Species Rat, mouse, dog, pig, etc.
Age Age in weeks, body weight
Gender Male versus female versus mix of genders used
Model of PAH MCT, CH, or SUHx
Severity of PAH RVSP or mPAP in control group
Cell preservation Fresh versus fresh from previously cryopreserved versus thawed cryopreserved product
Tissue source of regenerative cell product Bone marrow versus peripheral blood versus cord blood
Timing of cell administration following induction of PAH Early (<2 weeks) versus late (≥2 weeks) intervention
Follow-up duration Primary outcome assessed at 1, 2, 3, and 4+ weeks after intervention
Route of cell administration Intravenous versus intratracheal versus intraperitoneal versus intramuscular
Dose of cells e.g., 1 × 106 cells
Type of control PBS versus normal saline versus fibroblasts versus heat-killed cells
Cell modification Yes versus No
Number of participating study centers Single versus multi-center