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Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System
Joint Authors
Gupta, Saniya
Ponemone, Venkatesh
Sethi, Dalip
Suthar, Manish
Sharma, Monika
Powell, Richard J.
Harris, Kenneth Lee
Jungla, Nungshi
Arambam, Priyadarshini
Kaul, Upendra
Seth, Ashok
Bukhari, Suhail
Source
Issue
Vol. 2017, Issue 2017 (31 Dec. 2017), pp.1-16, 16 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2017-01-17
Country of Publication
Egypt
No. of Pages
16
Abstract EN
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.
American Psychological Association (APA)
Ponemone, Venkatesh& Gupta, Saniya& Sethi, Dalip& Suthar, Manish& Sharma, Monika& Powell, Richard J.…[et al.]. 2017. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System. Stem Cells International،Vol. 2017, no. 2017, pp.1-16.
https://search.emarefa.net/detail/BIM-1201519
Modern Language Association (MLA)
Ponemone, Venkatesh…[et al.]. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System. Stem Cells International No. 2017 (2017), pp.1-16.
https://search.emarefa.net/detail/BIM-1201519
American Medical Association (AMA)
Ponemone, Venkatesh& Gupta, Saniya& Sethi, Dalip& Suthar, Manish& Sharma, Monika& Powell, Richard J.…[et al.]. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System. Stem Cells International. 2017. Vol. 2017, no. 2017, pp.1-16.
https://search.emarefa.net/detail/BIM-1201519
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1201519