Aastrom, a cellular therapy company in Michigan, has finalized plans for a Phase III clinical study of Ixmyelocel-T as a treatment for Critical Limb Ischemia (CLI). CLI is the most serious form of Peripheral Artery Disease and results in a patient’s blood vessels becoming so blocked that surgeons must amputate the affected limb. The prognosis for patients with CLI is bleak. Aastrom states that CLI results in 160,000 amputations per year in the United States. Twenty-five percent of patients diagnosed with CLI die within 12 months and fewer than 25% live more than four years. Aastrom’s product provides hope to patients who have no other treatment options.
In June of this year the company announced that their Phase II study met safety and efficacy endpoints, which led them to begin planning their Phase III study. Aastrom worked with the Food and Drug Administration (FDA) to create a plan that would hopefully pave the way for them to receive Biologics Licensing Approval if the study is successful. The Phase III study will enroll 594 patients with no other treatment options and existing tissue loss. Patients with tissue loss are most at risk and are five times more likely to need amputation within 12 months. According to Aastrom’s CEO, Tim Mayleben, the study will take two and a half years to complete — 18 months for recruitment and 12 months of follow-up.
Aastrom’s treatment plan consists of harvesting the patient’s bone marrow, “selectively expanding mesenchymal, monocytes, and alternatively activated macrophages while retaining hematopoietic cells,” and finally administering the cells back to the patient. These cells, once introduced back into the patient, promote growth of new blood vessels in the affected limbs. Aastrom is one of the companies furthest along in the development of this type of Cell Therapy. The treatment, if approved, would provide a boost for Cell Therapy applications and continue to strengthen a growing market.