Assessing risk factors in stem cell therapies

by Alexey Bersenev on May 2, 2011 · 0 comments

in cell product, reviews

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It is extremely important to know and assess the risks of stem cell-based therapies. It is important for cell product developers, for physicians and their patients. Even if we can not exclude all of risks, we should able to make right decision for each patient based on risk/benefit ratio. Because cell therapy is relatively new field of medicine, risks assessment for it still in development. Today I’m sharing a review about risk factors in stem cell therapies.

The risk profile of stem cell based medicinal products depends on many risk factors, which include the type of stem cells, their differentiation status and proliferation capacity, the route of administration, the intended location, in vitro culture and/or other manipulation steps, irreversibility of treatment, need/possibility for concurrent tissue regeneration in case of irreversible tissue loss, and long-term survival of engrafted cells. Together these factors determine the risk profile associated with a stem cell based medicinal product. The identified risks (i.e. risks identified in clinical experience) or potential/theoretical risks (i.e. risks observed in animal studies) include tumour formation, unwanted immune responses and the transmission of adventitious agents.

This is a very good and unique review on the subject. Highly recommended!

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