Intraoperative Adjunctive Stem Cell Treatment in Patients with Critical Limb Ischemia Using a Novel Point-of-Care Device
published online 06 November 2009.
Introduction
In a prospective trial we tested whether adjunctive intraoperative stem cell treatment in patients with critical limb ischemia (CLI) can be performed safely in combination with bypass surgery and/or interventional treatment. The end point of our study was the safety and integrity of a novel point-of-care system used in patients with CLI.
Methods
We included only patients with CLI and tissue loss according to Rutherford categories 4-6. The Harvest Bone Marrow Aspirate Concentrate System consists of an automated, microprocessor-controlled dedicated centrifuge with decanting capability and the accessory BMAC Pack for processing a patient's bone marrow aspirate (BMA). The centrifuge is portable and enables BMA to be rapidly processed in the operating room to provide an autologous concentrate of nucleated cells for immediate injection. The surgeon aspirated 120 ml BMA from the iliac crest.
Results
Eight consecutive patients were treated according to the study protocol. The mean follow-up period was 9.2 months (range 2-18). Stem cells were always injected during the final revascularization attempt. One minor amputation and two major amputations were required. In five of eight patients there was a discrete increase in the ankle-brachial index post–stem cell treatment. The dose of stem cells after centrifugation was 17.2 (range 13.8-54.2)×10E6 CD34-positive cells and 7.8 (range 1.8-35.9)×10E6 CD133-positive cells. The injected dose of VEGFR-2-coexpressing stem cells was 0.5-5.7×10E4.
Conclusion
We were able to show that the buffy coat preparation using a point-of-care system is a simple and fast method to enrich stem cells from BMAs. This automated system gives high recovery rates and good reproducibility.
1Department of Vascular Surgery and Endovascular Therapy, Augusta Hospital and Catholic Clinics, Düsseldorf, Germany
2Stem Cell Department of Red Cross Blood Service West, Düsseldorf, Germany
3Department of Vascular Surgery, Carmel Medical Center, Haifa, Israel
Correspondence to: Ralf Kolvenbach, MD, PhD, Department of Vascular Surgery and Endovascular Therapy, Augusta Hospital and Catholic Clinics, Düsseldorf, Germany
ABSTRACT