Culture-expanded mesenchymal stromal cell (MSC)-like cells derived from marrow, adipose tissue or umbilical cord from either autologous or random donor sources are being studied in clinical trials across numerous regulatory jurisdictions worldwide (Figure 1). The ailments targeted with this cell pharmaceutical platform fall roughly within two categories: immune/inflammatory and tissue repair/ restoration. Across this spectrum of cell product and clinical indications, the interests of translational scientists and regulators intersect in best defining criteria for release and potency. The fairly well-established notions of sterility and cell viability (typically at least 70%) as release criteria are well accepted. The consensus onmarkers for identity of MSC-like cells is also reasonably well-defined. Thus, the minimum tripartite components of release criteria for cellular products in early-phase clinical trials—identity, viability and sterility—raise little practical controversy.
The challenge of defining mesenchymal stromal cell potency assays and their potential use as release criteria
KRAMPERA, Mauro
2015-01-01
Abstract
Culture-expanded mesenchymal stromal cell (MSC)-like cells derived from marrow, adipose tissue or umbilical cord from either autologous or random donor sources are being studied in clinical trials across numerous regulatory jurisdictions worldwide (Figure 1). The ailments targeted with this cell pharmaceutical platform fall roughly within two categories: immune/inflammatory and tissue repair/ restoration. Across this spectrum of cell product and clinical indications, the interests of translational scientists and regulators intersect in best defining criteria for release and potency. The fairly well-established notions of sterility and cell viability (typically at least 70%) as release criteria are well accepted. The consensus onmarkers for identity of MSC-like cells is also reasonably well-defined. Thus, the minimum tripartite components of release criteria for cellular products in early-phase clinical trials—identity, viability and sterility—raise little practical controversy.File | Dimensione | Formato | |
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