Initiation of the trial followed the Diabetes Center's receipt of the licenses and the Investigational Medicinal Product Dossier (IMPD) necessary to manufacture and use cells for clinical trials in compliance with the new European Union directives.

The Bad Oeynhausen study is a collaborative effort between Aastrom and the Diabetes Center. The principal investigator is Prof. Dr. Diethelm Tschöpe, Director of the Diabetes Center. Senior Physician Dr. P. Minartz, Dr. D. Lammers and Dr. rer. nat. B. Stratmann, members of the Diabetes Center, will serve as the Study Management Committee.

The aim of this human study is to evaluate the safety and ability of Aastrom's bone marrow-derived TRCs to regenerate functioning blood vessels in the legs of diabetic patients with limb ischemia. It is intended that the patients may experience relief from clinical problems that are related to a loss of blood circulation, such as: deep "bed-sore type" ulcerated wounds of the feet, pain (or "claudication"), immobility, and infection. Diabetic non-healing, infected ulcers often lead to the amputation of the leg. Successful vascular regeneration may either delay or render such amputation unnecessary. Standard of care treatments offer limited relief and are usually restricted to wound management and antibiotic treatment of the infected ulcers, in combination with surgical interventions such as the implant of stents with vascular by-pass or skin grafting.

"The initiation of this trial is an important step in our business strategy to use our TRC cell products for multiple medical indications. We are extending our clinical evaluations of the ability of these powerful cells to regenerate not only blood and bone but now, vascular tissue," said R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman of Aastrom. "The first phase of this study is intended to establish the safety of our TRCs in this application, and to evaluate their benefit to diabetic patients who have limited therapeutic options, and who may face eventual limb amputation."

It is expected that the first phase of the trial will be completed in approximately 12 months. All patients to be enrolled in the trial have been diagnosed with diabetes mellitus with ischemia-induced chronic tissue ulcers in the lower limbs (known as angiopathic or angioneuropathic diabetic foot syndrome), and are not suitable candidates for operative or interventional revascularization. Diabetics with such severe disease are the most difficult to treat and evaluate.

The design of this study includes control and treatment groups. The effects of TRCs will be compared to those of fresh, native bone marrow (active control), and to standard of care procedures. Two different routes of administration of the cells will be evaluated, with treatment patients receiving either direct injection into the ischemic limb at multiple sites, or a single intra-arterial injection above the affected tissue location. Initially, the trial will enroll 5 patients into each of the groups. The first set of data will be evaluated; based on this data, improvements and amendments to the protocol are expected to be introduced for the remaining patients.

Over the 12 months following treatment, the trial will evaluate whether the TRC treatment results in improved or complete healing of the ulcers, as well as whether amputation can be avoided or delayed. The trial will also monitor the time to relapse if complete wound healing is not attained, and whether the prognosis for patient survival improves, compared to standard of care controls.

Source Aastrom Biosciences, Inc.