Aastrom Biosciences ready for stem cell clinical trial for critical limb ischemia
By Tom Henderson
Ann Arbor-based Aastrom Biosciences Inc. (Nasdaq: ASTM) announced Wednesday that based on encouraging results from a Phase 2b clinical study of 46 patients with a condition known as critical limb ischemia, patients will be enrolled in a follow-up Phase 3 study of a stem cell-based therapy known as Restore-CLI.
Critical limb ischemia is the end stage of peripheral arterial disease, and patients with it face a high risk of amputation. Approximately one million patients in the U.S. suffer from the disease, with more than 160,000 amputations each year.
The results showed the therapy was as safe as treatment with a placebo and was more effective in controlling wound size and gangrene and delaying amputation.
?We look forward to presentation of the full data at an appropriate medical meeting,? said CEO and President Tim Mayleben of the Phase 2b results in a press release, ?and initiating the next phase of testing as soon as possible.?
http://www.crainsdetroit.com/article/20100224/GEO01/100229927#
By Tom Henderson
Ann Arbor-based Aastrom Biosciences Inc. (Nasdaq: ASTM) announced Wednesday that based on encouraging results from a Phase 2b clinical study of 46 patients with a condition known as critical limb ischemia, patients will be enrolled in a follow-up Phase 3 study of a stem cell-based therapy known as Restore-CLI.
Critical limb ischemia is the end stage of peripheral arterial disease, and patients with it face a high risk of amputation. Approximately one million patients in the U.S. suffer from the disease, with more than 160,000 amputations each year.
The results showed the therapy was as safe as treatment with a placebo and was more effective in controlling wound size and gangrene and delaying amputation.
?We look forward to presentation of the full data at an appropriate medical meeting,? said CEO and President Tim Mayleben of the Phase 2b results in a press release, ?and initiating the next phase of testing as soon as possible.?
http://www.crainsdetroit.com/article/20100224/GEO01/100229927#