Outcome measurement and follow-up
ABI, tumor necrosis, TNF-α, CLI, pain, Cancer
ADVERSE EVENT, TUMOR NECROSIS, ADVERSE EVENTS, LIMB ISCHEMIA, ULCERS, ULCERATION, CANCER
To assess the safety and effectiveness of P-MSC injections in the enrolled participants, we assessed medical records, electrocardiogram (ECG) results, vital signs (respiration, heart rate, blood pressure, oxygen saturation, and body temperature), blood chemistry, physical examination reports, digital photographs of wounds, and angiography at baseline and at the months follow-up.The primary safety evaluations that followed repeated doses of perinatal tissue MSC transplantation in no-option CLI patients, including tracking and documenting all possible adverse events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 5.0), were the main outcomes of the study.In addition to the usual safety laboratory measures, the levels of a few pro-inflammatory cytokines such as interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α), and interferon-γ (IFN-γ) were assessed to determine the immunological response to P-MSC transplantation (ELISA R&D, USA). Flow cytometry was used to compare the lymphocyte profiles before and after P-MSC administration in terms of CD4, CD8, and CD25 levels.In this study, in addition to investigating the safety of placental mesenchymal stem cell administration, efficacy endpoints were also investigated, including an increase in the ankle-brachial pressure index (ABI), maximal walking distance, vasculogenesis, relief of rest pain, healing of ulceration, and prevention of major amputation in the target limb.The visual analog scale (VAS) was used to evaluate pain, ranging from 0 for the best (totally resolved) to 10 for the most painful condition. Wound healing was evaluated using digital photographs of the ulcers. Objective criteria for limb ischemia included ABI measurements (Clinical trial methodology for intramuscular administration of P-MSC. 