Long Term Results of Stem Cell Therapy in Patients with Peripheral Arterial Disease (PAD)

Abstract

Peripheral Arterial Disease (PAD) is still a challenging condition affecting millions of people and leading to amputation or death. In patients with non reconstructable disease or failed revascularization, stem cell therapy (SCT) could help in promoting angiogenesis and limb salvage. However, there is limited data about the long-term benefits of SCT in such patients. Aim of this study is to evaluate the long-term survival and clinical outcomes in PAD patients who underwent stem cell therapy. All patients who underwent stem cell therapy using intramuscular injections of autologous bone-marrow mononuclear cells (BM-MNCs) for the treatment of PAD between January 2011 and November 2020 were include in the study. Electronic medical records (EMRs) and Telephonic phone follow up was used to get baseline clinical characteristics and follow up data. Out of 3627 PAD patient, 41 patients underwent stem cell therapy procedure between January 2011 to November 2020. Mean age was 48 years (range, 21 to 75 years) and 37 patients (90.24%) were males. The median follow-up period was 4.66 years (range, 6 months – 9.9 years). Indication for SCT was rest pain, gangrene or non-healing ulcer due to either non reconstructable disease or failed revascularization. All patients were given antiplatelets and statin therapy. Out of 41 PAD patients, 7 patients were lost to follow up. In the remaining, 34 patients, 29 (70.73%) patients were alive, and 5 patients were dead. Overall, 10 (24.39%) patients underwent ipsilateral amputation and 4 patients had persistent claudication pain. In the remaining patients’ ulcers healed and has no residual pain. Amputation free survival was 75.61%. The benefits of Autologous BM-MNCs stem cell therapy are sustained even in the long term with overall survival rate was 85.29% and the amputation free survival was 75.61% and should be considered for all CLI patients irrespective of age.