Speaker
Description
"Introduction
Critical limb ischemia (CLI) represents the final stage of peripheral arterial disease. Approximately one-third of patients with CLI are not candidates for conventional surgical treatment. Autologous bone marrow mononuclear cells (BM-MNC) and allogenic umbilical cord-derived mesenchymal stem cells (allo-UC-MSCs) have emerged as a promising therapeutic approach for this condition.
In the present work, we compare BM-MNC vs. UC-MSC, evaluating its safety and efficacy profile in comparison with the placebo group in patients with CLI.
Methodology
Fifteen injections of: (i) BM-MNC (7.197x106 ± 2.984 x106 cells/mL each with 2% of autologous serum), (ii) allo-UC-MSCs (1.333 x106 cells/mL each with 5% of human serum albumin serum) or (iii) vehicle (1 mL saline solution with 2% of autologous serum) were administered into the periadventitial arteries. Twenty-four patients in the most severe stages of the disease (category 4 or 5 in Rutherford’s classification and transcutaneous oxygen pressure (tcpO2) below 30 mm Hg were randomized to receive: (i) BM-MNC (n=7), (ii) allo-UC-MSCs (n=7) or (iii) placebo (n=10). The follow-up visits were at months 1, 3, 6 and 12, in order to evaluate the following parameters: (i) Rutherford classification, (ii) tcpO2, (iii) percentage of wound closure, (iv) pain, (v) pain-free walking distance, (vi) revascularization and loss of the limb during follow-up and (vii) the clinical outcome scale (EQ-5D questionnaire).
Results
No adverse events were reported. Patients with CLI that received BM-MNC and allo-UC-MSCs presented an improvement in Rutherford classification, a significant increase in tcpO2 values, clinical changes in the lesion size or its closure in a shorter time, a more noticeable decrease in the pain score, and an increase in the pain-free walking distance from the first-month post-treatment, in comparison with the control group. In addition, the participants treated with BM-MNC and allo-UC-MSCs kept their limbs during the follow-up period and surgery was not required, unlike the control group participants, who had a marked increase in the amputation of the affected limb and even two participants required a revascularization process.
Conclusion
Our cumulative results suggest that BM-MNC and allo-UC-MSCs in patients with CLI lead to significant clinical changes, being more noticeable in a shorter time with allo-UC-MSCs, unlike the control group where the participants increased their classification to a more severe stage of the disease: Rutherford 6. Thus, our pilot is clinically relevant as it highlights the possible use of BM-MNC or allo-UC-MSCs as a novel therapeutic approach to treat CLI, which could be part of its comprehensive management."
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