Aastrom Nearing Launch of Phase 3 Revive Clinical Trial for Critical Limb Ischemia
Dear Friends of Aastrom,
As you may have noticed, we recently redesigned the Aastrom website to help visitors access more information about our company. We hope this redesign makes it easier to learn about our work, mission and progress. To support the new site, we are also introducing a new blog about Aastrom where we will offer perspectives on important issues associated with our work and industry. I am very pleased to begin this new series with some comments on the disease that has been a primary focus of our work and research at Aastrom for the past several years—critical limb ischemia (CLI). (Learn more about critical limb ischemia or Aastrom’s CLI clinical trials, or watch the Living with CLI video.)
The importance of our CLI program cannot be overstated, as the need for a new treatment to help the millions of people affected by this terrible disease has never been greater.Having just returned from our clinical investigators’ meeting to prepare for the launch of our Phase 3 REVIVE clinical trial, I can attest to their excitement about evaluating our product candidate, ixmyelocel-T, as a potential treatment for people living with CLI who have no other treatment options. We are equally excited about the clinical and commercial potential of ixmyelocel-T following the positive results of our Phase 2b RESTORE-CLI clinical trial, which were presented in November 2011 at the American Heart Association Scientific Sessions.
CLI is a devastating and often fatal disease with few or even no treatment options available for many patients. In people with CLI, an obstruction of the arteries causes a decrease in blood flow to the extremities (hands, feet and legs). CLI is the most severe form of peripheral arterial disease (PAD). Currently, there are more than 10 million people living with PAD in the United States and one million people living with CLI.
In many cases, CLI results in a series of increasingly painful and challenging symptoms that can have a profoundly negative impact on a patient’s quality of life. These include:
- pain or numbness
- shiny, smooth, dry skin in the extremities
- nail thickening
- reduced pulse and blood pressure in the extremities
- development of sores, skin infections or ulcers that will not heal
These symptoms can lead to devastating health consequences, especially if they are not diagnosed early. Patients describe the pain associated with CLI as debilitating, making it impossible for them to complete many of the activities of normal life. People with CLI are often unable to sleep or relax without the use of the most powerful pain medications. In addition, the sores associated with CLI typically do not respond to conventional wound-healing treatments. As these wounds linger and progress, patients often develop gangrene and eventually require amputation—first minor amputations, but often ultimately leading to major amputation of the leg.
While there are many risk factors associated with CLI, the most prominent are a history of smoking, diabetes, obesity and atherosclerosis. Treatment options for earlier stages of CLI can include medications (statins, metformin, etc.), lifestyle changes including efforts to stop smoking, and open and endovascular surgical procedures to try to restore blood flow to the lower extremities.
My Aastrom colleagues and I are committed to finding a treatment for CLI and improving the lives of people afflicted by this devastating disease. Throughout our research we have been fortunate to meet and work with many of the world’s leading experts in vascular surgery and other specialties, as well as many CLI patients and their families, all of whom have helped us better understand the impact of this disease. During the past year, we have also worked closely with the FDA and key medical opinion leaders to develop the protocol for the Phase 3 clinical program we will be launching shortly. The REVIVE clinical trial will be the largest of its kind and an important test and milestone for ixmyelocel-T.
Thank you for visiting our site and taking time to learn more about Aastrom. We look forward to sharing new insights about our company and the patients we are committed to helping in the months and years ahead.