FDA approves pivotal IDE trial to evaluate autologous adult stem cells to treat patients with non-reconstructable critical limb ischaemia


Harvest Technologies announced on 22 March 2011 that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the USA using the company’s proprietary Bone Marrow Aspiration Concentrate (BMAC) system to treat patients with non-reconstructable critical limb ischaemia. The company anticipates that enrolment should begin early in the second quarter of this year.

“The patients enrolled in this study are at high risk for limb loss and death and have no usual treatment options with bypass or catheter-based techniques. Although the 48 patient randomised, double blinded, pilot trial (RCT) was aimed at determining the safety of this approach and not powered for efficacy, as will be the pivotal trial, the data suggested that there are benefits in terms of limb salvage, pain relief, and quality of life,” said Mark D Iafrati, chief of Vascular Surgery, Tufts Medical Center, Boston, USA, and principal investigator of the trial. “If the pivotal study confirms these findings this would be a dramatic affirmation of the role of autologous cellular therapy in critical limb ischaemia. BMAC therapy is so much faster, less invasive, and less expensive than traditional vascular interventions, that if proven efficacious will certainly result in an immediate change in the standard of care for patients with end stage peripheral vascular disease.” 


 “We are very privileged to work with the leading medical centres across the USA helping document what may be a significant treatment option for this extremely sick, no treatment option, patient population. The results generated from the company’s 48 patient FDA Safety and Pilot study and the results of the company’s additional BMAC studies in Europe and Asia, treating over 300 end-stage critical limb ischaemia patients, have all been extremely encouraging.


The Harvest BMAC system is a simple to use 15 minute point-of-care process that has been used in the treatment of approximately 50,000 patients to date. The system concentrates the cellular composition of the patient’s bone marrow, which contains the patient’s own stem cells. The BMAC System’s point-of-care approach, ease of use and its ability to deliver a cellular composition at an affordable price will be a major key in establishing this technique as a standard of care after the Company has received its FDA approval,” stated Gary Tureski, President Harvest Technologies.