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Table 1 Drug products manufactured from ABCB5+ MSCs for use as investigational medicinal products in clinical trials

From: Process data of allogeneic ex vivo-expanded ABCB5+ mesenchymal stromal cells for human use: off-the-shelf GMP-manufactured donor-independent ATMP

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)
  1. HRG Ringer’s lactate solution containing human serum albumin and glucose, MSC mesenchymal stromal cell
  2. aNumber of injection sites = 2/3 × lower leg length (defined as distance in cm between the popliteal space and the lateral malleolus). Injections are given according to a standardized injection site scheme with horizontal and vertical spacing between the injection sites of 3 cm
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Stem Cell Research & Therapy

ISSN: 1757-6512