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Stem Cells International
Volume 2017, Article ID 4137626, 16 pages
https://doi.org/10.1155/2017/4137626
Clinical Study

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System

1TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India
2Geisel School of Medicine, Dartmouth-Hitchcock Medical Centre, Lebanon, NH, USA
3Fortis Escorts Heart Institute and Research Centre, New Delhi, India

Correspondence should be addressed to Venkatesh Ponemone; moc.liamg@enomenop

Received 22 July 2016; Accepted 14 December 2016; Published 17 January 2017

Academic Editor: Thomas Ichim

Copyright © 2017 Venkatesh Ponemone et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.