Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II

Table 4 Dosage in MARSYAS II and toxicological studies

						Maximum doses in toxicological studies
	Concentration [U/ml]	Area dose [U/cm²]	Maximum area dose [U/cm²]	Dose [U/kg b.w.]	Dose [U/kg b.w.]	Dose [U/kg b.w.]	Dose [U/kg b.w.]	Dose [U/kg b.w.]
		Units per 1 cm²	Units per 8 cm²	Minimum dose per 1 cm²	Maximum dose per 8 cm²	Single dose i.v. rats	4 weeks repeated dose i.v. mice	4 week repeated dose s.c. minipigs
Low dose	12.5	6.25	50	0.104	0.833
Medium dose	25.0	12.5	100	0.208	1.667
High dose	50.0	25	200	0.417	3.333	500	500	33.3

Minimum dose/wound treatment, 6.25 U/cm². Maximum dose/wound treatment, 200 U/8 cm²
U Units, b.w. body weight, i.v. intravenous, s.c. subcutaneous

ISSN: 1745-6215