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Table 2 Investigational Medicinal Product (IMP) specification

From: A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia

Description Specifications
Morphology Cells are fibroblastic and spindle shaped in active growing condition.
Cells are intact and round in shape after the trypsin action
Cell count 180 to 220 million cells per bag
Viability > 85%
Cell phenotype CD 73 > 80% CD 34 < 5%
CD105 > 80% CD 45 < 5%
CD 90 > 80% CD 133 < 5%
CD 166 > 80% CD 14 < 5%
CD19 < 5%
HLA-DR < 5%
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