1. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.
- Author
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Ponemone, Venkatesh, Gupta, Saniya, Sethi, Dalip, Suthar, Manish, Sharma, Monika, Powell, Richard J., Harris, Kenneth Lee, Jungla, Nungshi, Arambam, Priyadarshini, Kaul, Upendra, Seth, Ashok, and Bukhari, Suhail
- Subjects
PERIPHERAL vascular disease treatment ,ISCHEMIA treatment ,BONE marrow cells ,BLOOD flow ,REVASCULARIZATION (Surgery) ,POINT-of-care testing - 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 (TcPO
2 ), 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. [ABSTRACT FROM AUTHOR]- Published
- 2017
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