Product | Clinical trial | Product characteristics | |||||||
---|---|---|---|---|---|---|---|---|---|
Name | Number of batches produced (total: 85) | ClinicalTrials.gov identifier | Indication | Application route | Cell dose per application | Composition | Total live cell count | Container | Pack size |
allo-APZ2-CVU | 30 | NCT03257098 | Chronic venous ulcer | topical | 1 × 106 cells/cm2 wound surface | 1 × 107 ABCB5+ MSCs in 1 ml HRG | dependent on wound size (max. 100 × 106) | 1-ml syringe | 1–10 syringes (dependent on wound size) |
allo-APZ2-DFU | 26 | NCT03267784 | Diabetic foot ulcer | topical | 2 × 106 cells/cm2 wound surface | 1 × 107 ABCB5+ MSCs in 1 ml HRG | 1-ml syringe | 1–10 syringes (dependent on wound size) | |
allo-APZ2-EB | 23 | NCT03529877 | Epidermolysis bullosa (recessive dystrophic) | intravenous | 2 × 106 cells/kg body weight | 1 × 107 ABCB5+ MSCs in 1 ml HRG | dependent on body weight | 10-ml syringe | 1–2 syringes (dependent on body weight) |
allo-APZ2-ACLF | 3 | NCT03860155 | Acute-on-chronic liver failure | intravenous | 1 × 107 ABCB5+ MSCs in 1 ml HRG | dependent on body weight | 10-ml syringe | 1–2 syringes (dependent on body weight) | |
allo-APZ2-PAOD | 3 | NCT03339973 | Peripheral artery disease | intramuscular | 7.5 × 106 cells per injection site (20–30 injection sites, depending on leg length)a | 1 × 107 ABCB5+ MSCs in 1 ml HRG | 150 × 106–225 × 106, dependent on leg length | 1-ml syringe | 20–30 syringes (number equal to the number of injection sites) |