Aastrom Biosciences, Inc. has announced that the first critical limb ischemia (CLI) patient was treated at the Malcom Randall Veterans Affairs (VA) Medical Center in Gainesville, FL.
The Company is evaluating its Vascular Repair Cell (VRC) product in a U.S. Phase IIb clinical trial to treat patients suffering from CLI, the most severe form of peripheral arterial disease (PAD).
Approximately 900,000 people suffer from CLI, which leads to 100,000 major amputations per year in the U.S. CLI patients endure chronic ischemia-induced pain (even at rest), ulcers, tissue loss or gangrene in the limbs, and represent the end stage for PAD patients.
"Current surgical or endovascular techniques for limb revascularizations are often limited by anatomic constraints in patients with CLI. These patients suffer from rest pain and frequently have no other options for revascularization. Typically we see these patients over the course of several years. They come to us with severe pain, and on evaluation typically have long segments of their arteries blocked so that it is impossible for us to reestablish blood flow by any conventional means," commented Scott A. Berceli, M.D., Ph.D., Principal Investigator at the VA Medical Center.
Berceli continued, "Unfortunately, these patients often go on to develop gangrene of the toes, requiring successive amputation surgery. Due to inadequate perfusion, the wounds from these surgeries often do not heal, leading to a vicious cycle of repeat amputations with wound healing complications.
"The ability to improve blood flow to the limbs in patients such as this through vascular tissue regeneration provides the next generation of therapeutic options, and VRCs stand at the forefront of these approaches."
Aastrom's VRCs are based on the Company's Tissue Repair Cell Technology, which enables patient-specific stem cell products for multiple regenerative medicine applications. Aastrom manufactures VRCs for vascular tissue regeneration in an automated, GMP (Good Manufacturing Practices) process.
"Our VRCs are composed of stem and progenitor cells that we believe are required for tissue regeneration in the human body. A normal dose of VRCs contains significantly more of these key cells than can normally be harvested from a patient," stated Elmar R. Burchardt, M.D., Ph.D., Vice President, Medical Affairs of Aastrom.
"These large numbers of stem and progenitor cells may be extremely important when treating critical limb ischemia patients with severely impaired blood flow that can affect the majority of their lower leg."
In addition to the VA Medical Center in Gainesville, FL, four other sites have been initiated and trained, including: Southern Illinois University School of Medicine, Springfield, IL; St. Joseph Mercy Hospital, Ann Arbor, MI; Michigan Vascular Research Center, Flint, MI; and, Vanderbilt University Medical Center, Nashville, TN. Aastrom will update its website as other clinical sites are initiated and trained.