Table 2 Data collection elements

Study characteristics

Study title, author, date of publication, journal published, country of publication, randomization process

Study population (animal model)

Animal type, age, gender, strain, and weight, presence of co-morbid illnesses

Model of inflammation and method of induction

Acute or chronic, direct or indirect infection, chemical-induced injury, ischemia-reperfusion, surgically induced model, details of model induction process

Intervention and comparison

International Society for Cellular Therapy criteria, MSC tissue source, MSC characteristics (including method of sorting), time and route of MSC administration, description of preparation and suspension of MSCs and controls (including medium used for cells, duration of culture, passage number, concentration/amount of MSCs used), vehicle used for delivery, storage conditions, cryopreservation methods (duration of cryopreservation, method used to cryopreserved MSCs, and concentration of MSCs during cryopreservation, and medium used to cryopreserve and whether any additives were used), post-thaw washing procedure and time to use in experiment, time from disease induction to MSC administration, MSC viability, surface marker expression

Co-interventions

Antibiotics, cytokines, cultured medium, membrane/scaffold system employed

Potency

MSC secretome and release assay, MSC effect on various cells, and PBMC proliferation co-culture assay

Surrogate markers of efficacy

Preclinical outcomes that are relevant as per the model of inflammation employed and fall within the two domains of organ dysfunction and protein expression and secretion: examples include arterial oxygenation, lung compliance, neovascularization, epithelialization, wound contraction rate, arthritic index, histological lung injury, etc.

Other

Presence of a priori sample size calculation.

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