Currently, the use of Mesenchymal Stem Cells (MSCs) for treating various diseases has been approved in many countries, although the specific approval processes vary. For example:
Graft-versus-host disease following bone marrow transplantation is approved for MSC treatment in Canada and Japan.
Crohn's disease is approved for MSC treatment in European countries.
Buerger's disease is approved for MSC treatment in India.
Spinal cord injuries are approved for MSC treatment in Japan.
ALS and osteoarthritis are approved for MSC treatment in South Korea.
However, the research required for drug registration is extremely costly. New drugs often require billions of dollars in investment, making research to support the registration of stem cell therapies increasingly difficult.
Stem cells are living cells and cannot be packaged and sold like ordinary drugs. Mesenchymal stem cells, in particular, require several weeks of culturing to reach therapeutic quantities. They must undergo rigorous testing to ensure they are free of contamination and safe for use. They are often stored frozen in liquid nitrogen until needed and have a limited lifespan once thawed.
Any product that does not meet these criteria cannot be considered a living cell or a mesenchymal stem cell.
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