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Table 4 Dosage in MARSYAS II and toxicological studies

From: 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

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