How to Design Clinical Trials of Stem Cells and BMAC in Orthopedic Surgery
Pp. 36-50 (15)
Ahmed S. Negida, Salma Y. Fala, Mohamed A. Imam and Bassem T. Elhassan
Stem cells research is considered as one of the most promising technics
recently. In orthopedic, the use of stem cells therapy on humans is still challenging. As
a result of the novelty of these technics, the researchers need a guideline to highlight
the key issues in the clinical practice of stem cells research to protect the wellbeing,
safety and rights of the research subjects. Moreover, several methodological and ethical
issues are still questionable regarding stem cells trials in humans as: (1) avoiding
expertise Bias; (2) selecting appropriate participants; and (3) determining a reliable
therapeutic end point. So, in this chapter we will highlight the key points on how to run
a clinical trial and how to overcome the methodological challenges in the research of
stem cells regarding orthopedic surgery.
Bone Marrow Aspirate Concentrate (BMAC), Clinical trials, Clinical
trial design, Expanded stem cells, Expertise Bias, Informed consent, Medical
research, MSCs, Randomised Clinical trials, Sample size.
Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, 44519 Egypt.