How to Design Clinical Trials of Stem Cells and BMAC in Orthopedic Surgery

Pp: 36-50 (15)

* (Excluding Mailing and Handling)

Abstract

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.

Keywords: 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.