Table 4 Elements of external validity
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 |