Table 2 Specifications for the release of clinical grade BM-MSC for clinical use
From: Stability enhancement of clinical grade multipotent mesenchymal stromal cell-based products
Critical quality attribute | Acceptance criteria |
|---|---|
Viability | ≥ 70% |
Identity | ≥ 95% CD105, CD73, CD90 ≤ 5% CD45 and CD31 ≤ 20% *HLA-DR |
Potency | Osteogenic, chondrogenic and adipogenic potential in vitro |