A Meta-Analysis of Randomized Controlled Trials on Therapeutic Efficacy and Safety of Autologous Cell Therapy for Atherosclerosis Obliterans – DocWire…

J Vasc Surg. 2021 Nov 14:S0741-5214(21)02437-X. doi: 10.1016/j.jvs.2021.10.051. Online ahead of print.

ABSTRACT

BACKGROUND: Atherosclerosis obliterans (ASO) is a chronic occlusive arterial disease and the most common type of peripheral arterial disease. Current treatment options like medication and vascularization have limited effects for no-option patients, and stem cell therapy is considered a viable option although its application and efficacy have not been standardized. The objective of this review was to assess the safety and efficacy of autologous stem cell therapy in patients with ASO.

METHODS: We performed a literature search of published RCTs for ASO patients receiving stem cell therapy without a revascularization option. PubMed, Embase, and the Cochrane Library were searched. This study was conducted by a pair of authors independently and audited by a third author. Data were synthesized with a random-effect model.

RESULTS: 630 patients in 12 RCTs were included. The results showed that cell therapy significantly improved total amputation (RR: 0.64, p = 0.004, 95% CI: [0.47, 0.87]), major amputation (RR: 0.69, p = 0.02, 95% CI: [0.50, 0.94]), ankle-brachial index (ABI) (MD = 0.08, p = 0.004, 95% CI: [0.02, 0.13]), transcutaneous oxygen tension (TcO2) (MD = 11.52, p = 0.004, 95% CI: [3.60, 19.43]) and rest pain score (MD = -0.64, p = 0.007, 95% CI: [-1.10, -0.17]) compared to placebo or standard care. However, current studies showed cell therapy was not superior to placebo or standard care in all-cause death (RR: 0.75, p = 0.34, 95% CI: [0.41, 1.36]) and ulcer size (MD = -8.85, p = 0.39, CI: [-29.05,11.36]).

LIMITATION: The number of trials included was limited. Moreover, most trials were designed for no-option patients and thus the results should be applied with caution to other PAD patients.

CONCLUSION: ASO patients can benefit from autologous cell therapy in limb salvage, limb blood perfusion, and rest pain alleviation.

PMID:34788653 | DOI:10.1016/j.jvs.2021.10.051

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A Meta-Analysis of Randomized Controlled Trials on Therapeutic Efficacy and Safety of Autologous Cell Therapy for Atherosclerosis Obliterans - DocWire...