title: Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.
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.
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Venkatesh
authors.identifier: 0000-0003-0869-5591
authors.initials: V
authors.lastname: Ponemone
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Saniya
authors.initials: S
authors.lastname: Gupta
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Dalip
authors.initials: D
authors.lastname: Sethi
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Manish
authors.identifier: 0000-0001-9605-1459
authors.initials: M
authors.lastname: Suthar
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Monika
authors.identifier: 0000-0002-9691-5218
authors.initials: M
authors.lastname: Sharma
authors.affiliation: Geisel School of Medicine, Dartmouth-Hitchcock Medical Centre, Lebanon, NH, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.affiliation: TotipotentRX Centre for Cellular Medicine, Subsidiary of Cesca Therapeutics Inc., Gurgaon, India.
authors.forename: Kenneth Lee
authors.initials: KL
authors.lastname: Harris
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India.
authors.forename: Nungshi
authors.initials: N
authors.lastname: Jungla
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India.
authors.forename: Priyadarshini
authors.initials: P
authors.lastname: Arambam
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India.
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Seth
authors.affiliation: Fortis Escorts Heart Institute and Research Centre, New Delhi, India.
authors.forename: Suhail
authors.initials: S
authors.lastname: Bukhari