Safety profile
death, hematomas, swelling, fever, toxicity, inflammation, malignancy, amputation, allergies, ulcer
HEMATOMAS, ADVERSE EVENTS, INFLAMMATION, ALLERGIES, EVENTS, ULCER
The trial's primary endpoint was to determine the safety of auto-BM-MNC and allo-WJ-MSC administration; for that, we assessed the number of treatment-related adverse events (AEs) reported for each study group according to the Common Terminology Criteria for AE classification. AEs were defined as (i) local toxicity, including signs of local inflammation (swelling, warmth, impairment of function), worsening of ulcer, new ulcer, or hematomas after the cell administration, (ii) systemic toxicity as fever, allergies, and (iii) other AEs, graded according to the Common Terminology Criteria for AEs, expressed as maximum grade toxicity for tissue.Secondary safety outcomes include any severe AEs post-treatment, defined as events leading to hospitalization, malignancy, amputation, persistent or significant disability, or death.We documented AEs at each visit and described them in terms of incidence, severity, and relatedness with macroscopic changes in the leg.