Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia

Table 1 Functional and clinical endpoints in MSC therapy of critical limb ischemia (CLI) trials

SAFETY	Adverse events (AEs)		Death
			MACEs
			Anemia
			Bleeding
			Pain
			Fever
			Infection
			Transient allergic reactions
			Injection-induced rhabdomyolysis
			Kidney injury
			Gangrene
			Proliferative retinopathy
			Unregulated Angiogenesis: Arterio-Venous (A-V) Malformations and Retinopathy
			GVHD
			Cancer
	Immunogenicity		Plasma cytokine levels (TNF-a, IL-6, and IL-1b)
			Lymphocyte profile (CD4, CD8 and CD25)
EFFICCY	Functional endpoints	Subjective perfusion endpoints	Ischemia severity according to Rutherford or Fontaine
			Ulcer healing
			Pain score
			Quality of life (SF-36 or VascuQoL)
			Exercise treadmill test (PWD)
		Objective perfusion endpoints	ABI, TcpO2, TBI
		Objective perfusion endpoints	Angiography
	Clinical endpoints	Death rate
		Amputation rate
		Major amputation of the index leg
		Amputation-free survival
		Time to death or amputation of the index leg

ABI ankle-brachial index, AEs adverse events, GVHD graft-versus-host disease, MACEs major adverse cardiovascular events, MWD maximal walking distance, PWD pain-free walking distance, TBI toe-brachial index, TcPO₂ transcutaneous oxygen pressure

ISSN: 1757-6512