The peripheral blood mononuclear cells versus purified CD34+ cells transplantation in patients with angiitis-induced critical limb ischemia trial: 5-year outcomes and return to work analysis—a randomized single-blinded non-inferiority trial

Table 1 Safety Outcomes of All Patients through 60 months based on worst-case scenarios

	PBMNCs group (n = 25)	PCCs group (n = 25)	P value
Mobilization-related adverse events^*, n (%)	5 (20.0)	7 (28.0)	0.508
Pain at injection site, n (%)	14 (56.0)	2 (8.0)	< 0.001
Elevation of leukocyte counts > 3 days after transplantation, n (%)	1 (4.0)	2 (8.0)	0.552
All-cause mortality, n (%)	0 (0.0)	3 (12.0)^†	0.074
Cardiovascular events, n (%)	0 (0.0)	1 (4.0)	0.312
Cerebrovascular events, n (%)	0 (0.0)	2 (8.0)	0.149
Pathological retinal angiogenesis, n (%)	0 (0)	0 (0.0)	1.000

The data presented are the numbers (%)
PBMNCs, peripheral blood mononuclear cells; PCCs, purified CD34⁺ cells
*Mobilization-related adverse events included slight fevers, transient headaches, back pains, and pruritus
^†A lost patient was calculated based on worst-case scenarios

ISSN: 1757-6512