Adipose-derived stromal cells: Their identity and uses in clinical trials, an update

Table 2 The different steps for a clinical trialand cancer cells

Steps of clinical trial	Elements of discussion
Design	Autologous
	Immunocompatibility
	Lag of time between fat sampling and delivery
	Amount of cells
	Allogenic
	Histocompability issue
	If bank, ready to use treatment
	Inclusion criteria
	Too broad: leads to wrong conclusions associated with great variability and independent parameters,
	Too restricted: enrolment difficulties associated with non relevant and inadequate parameters
	Exclusion criteria
	Too broad: enrolment difficulties associated with non relevant and inadequate parameters
	Too restricted: risks of adverse side effects associated with interactions between transplanted cells and undesirable context
	Number of patients: statistically defined
	Objective and well-established criteria of safety and efficacy
	Uni or multicenter analysis
	Standardization of procedures between centers
	Efficiency of enrolment
Sampling	Liposuction:
	Local anesthesia
	Fat depot
	Technique (no ultra-sound)
	Anti-coagulant
Culture	Opened or closed system
	Bovine or human-derived products
	Number of passages
	Quality and Safety control
	Release criteria
Injection	iv
	Poorly invasive but large distribution and mostly trapped in lung
	im or intra tissue
	More invasive
	More restricted localization
	Pressure challenge for adipose-derived stromal cells
Monitoring of the tolerance and the safety	Criteria: pain, wound healing, inflammation, immunology, tumor
	Kinetics for analysis
	Short and long term safety
Monitoring of the results	Objective criteria, standardisation of procedures
Analysis of the results	Adequate statisitic
	Stick to primary and secondary aims