A Phase I Study of Human Cord Blood-Derived Mesenchymal Stem Cell Therapy in Patients with Peripheral Arterial Occlusive Disease

摘要

Approach In this open-label, single-center, prospective phase I trial, eight male patients (median age: 52 years; range: 31 to 77 years) with peripheral arterial occlusive disease (POAD) who were considered ineligible for further revascularization to improve CLI were enrolled. CLIs defined as category 3, 4, 5 or 6 on the Rutherford scale were included. Patients less than 18 years of age or with a history of leg bypass graft and/ or angioplasty within the past two months, prior gene or cell therapy for limb ischemia, unstable cardiovascular disease, autoimmune conditions and anaphylactic shock or allergy were excluded. Patients with malignant disease or with abnormal lab findings with respect to WBCs, platelets, hemoglobin Ale, creatinine and/or alanine transaminase (ALT) were also excluded.