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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