CLINICAL TRIAL NEWS

Use of Aastrom Tissue Repair Cell-Based Autologous Bone Marrow Cells in Patients With Peripheral Arterial Disease is a randomized, double-blind placebo-controlled, parallel-assignment study to determine the safety and efficacy of a tissue repair cell-based (TRC) system for treating patients with peripheral arterial disease for critical limb ischemia. The study is currently recruiting. Inclusion criteria include patients of either gender between 18 years and 81 years of age, a diagnosis of critical limb ischemia, infrainguinal occlusive disease without options for revascularization, a life expectancy of at least 2 years, normal organ and marrow function, controlled blood pressure, and established antiplatelet therapy. Exclusion criteria include poorly controlled diabetes mellitus. The treatment group will receive intramuscular injections of Aastrom's TRCs, a proprietary mixture of stem and progenitor cells derived from the patient's own bone marrow. The primary outcome is the absence of major amputation 1 year after treatment. Secondary outcomes include healing of all wounds in the target limb, measurements of wound size and wound, ankle pressure, ankle brachial pressure index, reduced rest pain, and pain-free walking, all 1 year after treatment. The study which is sponsored by Aastrom Biosciences, began in April 2007, and has a total expected enrollment of 120 patients, with an expected completion in April 2009. The ClinicalTrials.gov identifier is NCT00468000.

Intraocular Pressure During Abdominal Aortic Aneurysm Repair is an observational, cross-sectional prospective study to determine the natural history of the effect of aortic infrarenal clamping and unclamping on intraocular pressure during AAA repair. Perioperative blindness is often ascribed to increases in intraocular pressure during spinal and cardiac surgery. The study hypothesis is that intraocular pressure will also increase during aortic cross-clamping in surgical AAA repair and decrease following unclamping. The study is currently recruiting patients. Inclusion criteria include all patients presenting to St. Boniface General Hospital for elective AAA repair requiring an arterial line, central line, and general anesthesia. Patients will be excluded if they have a history of acute or chronic eye disease and if they are vancomycin-resistant enterococci or methicillin-resistant Staphylococcus aureus positive due to infection-control reasons. The study which is sponsored by the University of Manitoba, Winnipeg, Canada, began in March 2007, and has a total expected enrollment of 20 patients, with an expected completion in August 2007. The ClinicalTrials.gov identifier is NCT00450294.