Patient recruitment and study design
arterial occlusion, diabetus mellitus, CLI, toxicity, diabetic foot, thromboangiitis
ARTERIAL OCCLUSION, DISEASE, HYPERCHOLESTEROLEMIA, DIABETIC FOOT, THROMBOANGIITIS, BUERGER DISEASE, TAO
Individuals with CLI who participated in the inpatient and outpatient vascular surgery services at Taleghani Hospital, whose primary treating vascular surgeons determined that they were not eligible for surgical or endovascular intervention but were considered suitable candidates, were offered to participate in this trial. Nine patients with CLI were included in the trial: two with diabetic foot and seven with TAO (Table Demographic and baseline disease conditionHC: Hypercholesterolemia; ESH: ex smoke habit; BD: Buerger disease; AS: active smoker; DM: diabetus mellitus; TAO: thromboangiitis obliteransThe enrolled CLI patients had complete arterial occlusion without run-off of the lower extremities, as verified by conventional diagnostic angiography. Table Eligibility criteria for patients enrolled in the studyBased on the trial entrance order, eligible patients were randomized into one of the two P-MSC dosing cohorts. A 3 + 3 dose escalation approach was adopted, with three–six patients in each P-MSC dose cohort: 20 × 10A DLT was described in this study as a grade 2 toxicity or any grade 3 toxicity expected to be attributable to P-MSC administration that did not resolve during the 14 days. The highest P-MSC dosage for which the prevalence of DLTs was less than or equal to one case was regarded as the MTD. If two or more subjects developed a DLT during the 14 days of administration, the MTD was considered to have been exceeded.