Concise Review: Workshop Review: Understanding and Assessing the Risks of Stem Cell-Based Therapies

Concise Review : Workshop Review: Understanding and Assessing the Risks of Stem Cell-Based Therapies

The field of stem cell therapeutics is moving ever closer to widespread application in the clinic. However, despite the undoubted potential held by these therapies, the balance between risk and benefit remains difficult to predict. As in any new field, a lack of previous application in man and gaps in the underlying science mean that regulators and investigators continue to look for a balance between minimizing potential risk and ensuring therapies are not needlessly kept from patients. Here, we attempt to identify the important safety issues, assessing the current advances in scientific knowledge and how they may translate to clinical therapeutic strategies in the identification and management of these risks. We also investigate the tools and techniques currently available to researchers during preclinical and clinical development of stem cell products, their utility and limitations, and how these tools may be strategically used in the development of these therapies. We conclude that ensuring safety through cutting-edge science and robust assays, coupled with regular and open discussions between regulators and academic/industrial investigators, is likely to prove the most fruitful route to ensuring the safest possible development of new products.

MEDICIN OCH HÄLSOVETENSKAP Medicinsk bioteknologi Medicinsk bioteknologi hsv//swe
MEDICAL AND HEALTH SCIENCES Medical Biotechnology Medical Biotechnology hsv//eng
Adult stem cells
Autologous stem cell transplantation
Cellular therapy
Stem cell expansion
In vivo tracking
Pluripotent stem cells
Stem cell transplantation
Stem cell

Hammond, Thomas G. (author)
Santeramo, Ilaria (author)
Piella, Agnes Tort (author)
Hopp, Isabel (author)
Zhou, Jing (author)
Baty, Roua (author)
Graziano, Enrique I. (author)
Marco, Bernabe Proto (author)
Caron, Alexis (author)
Sköld, PatrikUppsala universitet,Institutionen för farmaceutisk biovetenskap (author)
Andrews, Peter W. (author)
Baxter, Melissa A. (author)
Hay, David C. (author)
Hamdam, Junnat (author)
Sharpe, Michaela E. (author)
Patel, Sara (author)
Jones, David R. (author)
Reinhardt, Jens (author)
Danen, Erik H. J. (author)
Ben-David, Uri (author)
Stacey, Glyn (author)
Bjorquist, Petter (author)
Piner, Jacqueline (author)
Mills, John (author)
Rowe, Cliff (author)
Pellegrini, Giovanni (author)
Sethu, Swaminathan (author)
Antoine, Daniel J. (author)
Cross, Michael J. (author)
Murray, Patricia (author)
Williams, Dominic P. (author)
Kitteringham, Neil R. (author)
Goldring, Chris E. P. (author)
Park, B. Kevin (author)
Uppsala universitetInstitutionen för farmaceutisk biovetenskap (creator_code:org_t)

In:Stem Cells Translational Medicine: Oxford University Press (OUP)4:4, s. 389-4002157-65642157-6580

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Medical Biotechn ...; and Medical Biotechn ...

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