New article presents data on safety of mesenchymal stem cells.
Safety of Mesenchymal Stem Cells for Clinical Application
Key points:
There is no evidence for tumorigenicity of MSCs expanded in vitro.
The authors performed GLP-compliant in vivo toxicity studies using NOD mice,
NOD/SCID mice, guinea pigs, rabbits, and monkey models.
Subcutaneous injection of 10 million culture expanded mesenchymal cells from umbilical cord did not induce tumor formation in both NOD mice and NOD/SCID mice.
Large, 2 million and 10 million cells/kg doses were given to cynomolgus monkeys once per week for six weeks. No significant mesenchymal stem cell-related changes were found in body weights, clinical signs, hematological/biochemical values, organ weights, or histopathological findings.
The cells inhibited tumor growth in mice. “Two injections (two week interval) of different doses of UC-MSCs [umbilical cord-mesenchymal stem cells] resulted in a significant inhibition of K562 tumor growth in the mice bearing leukemic tumors.
No significant MSCs-related changes were found in body weights, clinical signs, hematological/biochemical values, organ weights, or histopathological findings.
Safety of Mesenchymal Stem Cells for Clinical Application
Youwei Wang, 1 Zhi-bo Han, 1 Yong-ping Song, 2 and Zhong Chao Han 1, 2 , *
Abstract
Mesenchymal stem cells (MSCs) hold great promise as therapeutic agents in regenerative medicine and autoimmune diseases, based on their differentiation abilities and immunosuppressive properties. However, the therapeutic applications raise a series of questions about the safety of culture-expanded MSCs for human use. This paper summarized recent findings about safety issues of MSCs, in particular their genetic stability in long-term in vitro expansion, their cryopreservation, banking, and the role of serum in the preparation of MSCs.