BIOMAT Database Logo BIOMAT Database Logo

Points to Consider in Designing Mesenchymal Stem Cell-Based Clinical Trials. 2008

Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Mater Medical Research Institute, Brisbane, Queensland, Australia.

SUMMARY: Therapeutic applications of cells are likely to increase greatly in the future. Cell and cell-based gene therapy manufacturing facilities need to be purpose-designed and accredited by their national medicinal regulatory body. Production scientists need to work in close tandem with quality assurance and ethics committees to absolutely ensure the safety of new cellular products. In this review, we consider the need for preclinical safety and efficacy data, tissue source for manufacture of clinical grade human mesenchymal stem cells, aseptic tissue processing, indemnification, and the role of the national medicinal regulatory body in appropriate clinical trial design.

UI MeSH Term Description Entries

Related Publications

Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Translation of stem cell research: points to consider in designing preclinical animal studies.
May 2012, Stem cells translational medicine,
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Points to consider for designing trials in systemic sclerosis patients with arthritic involvement.
September 2017, Rheumatology (Oxford, England),
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Conducting clinical trials in outbreak settings: Points to consider.
February 2016, Clinical trials (London, England),
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Stem cell therapy in stroke: designing clinical trials.
September 2011, Neurochemistry international,
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Muscle involvement in systemic sclerosis: points to consider in clinical trials.
September 2017, Rheumatology (Oxford, England),
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Blinding in pharmaceutical clinical trials: An overview of points to consider.
July 2015, Contemporary clinical trials,
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards.
January 2015, Rheumatology (Oxford, England),
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Designing a diagnostic imaging facility: some points to consider.
April 1981, Hospitals,
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
Points to Consider in Designing and Conducting Juvenile Toxicology Studies.
January 2017, International journal of toxicology,
Gary Brooke, and Tony Rossetti, and Nina Ilic, and Patricia Murray, and Sonia Hancock, and Rebecca Pelekanos, and Kerry Atkinson
EULAR points to consider for conducting clinical trials in systemic lupus erythematosus.
April 2009, Annals of the rheumatic diseases,
Copied contents to your clipboard!