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Table 5 Elements of construct validity and external validity

From: Efficacy and safety of mesenchymal stromal cells in preclinical models of acute lung injury: a systematic review protocol

Category

Specific items

Death

True death versus surrogate endpoints

Animal species

Mouse, rat, sheep, pig, other

Strain

Example for mice: BALB/c versus C57Bl/6

Animal age

Mature adult versus middle-aged versus older adult for each species (for example mouse 3 to 10 months, 10 to 18 months, 18 to 24 months)

Gender

Male versus female versus mix of genders used

Model of acute lung injury

See Table 2

Presence of co-morbidities

Yes versus no

Severity of lung injury

Lung injury score

MSC preparation

Fresh versus fresh from previously cryopreserved versus thawed cryopreserved product

Timing of MSC administration following induction of acute lung injury

0 to 1 hours versus 1 to 6 hours versus >6 hours

Route of MSC administration

Intravenous versus intratracheal versus intraperitoneal versus intramuscular

Type of control

PBS versus normal saline versus fibroblasts versus heat-killed MSCs

Use of co-interventions

Resuscitation fluids: yes versus no Use of antibiotics in infectious models: yes versus no

Mechanical ventilation

Yes versus no

Number of participating study centers

Single versus multi-center

  1. MSC, mesenchymal stromal cell; PBS, phosphate buffered saline.