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Fig. 2 | Trials

Fig. 2

From: Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)

Fig. 2

Cell therapy product flowchart. From GMP laboratory to the patient. MCB, master cell bank; WCB, working cell bank; MSC, mesenchymal stromal cells. Ad-MSC are isolated from the adipose tissue sample and cultured at two passages until reaching a minimum dose of 250 × 106 cells. Characterization of the cells and quality controls are established during the whole process. When a study subject is assigned to active treatment group, the sponsor notifies the assigned WCB laboratory to thaw and culture the cells in one passage. The batch is then packaged, labeled, and sent to the pharmacy service of the intended hospital. Manufacture process has been authorized by the Spanish competent authority (AEMPS), PEI number 15-103 Version 4:7/07/2019.

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Trials

ISSN: 1745-6215