William Marston of the UNC Center for Heart and Vascular Care begins Phase 3 Study of Autologous Stem Cells

Dr. Marston's study of autologous stem cells is for the treatment of patients with Critical Limb Ischemia to reduce the need for amputations.

William Marston of the UNC Center for Heart and Vascular Care begins Phase 3 Study of Autologous Stem Cells click to enlarge Dr. William Marston

Dr. William Marston, Medical Director of the UNC Wound Management Center, met with the REVIVE clinical trial steering committee last month as he begins the Phase 3 study of autologous stem cells for the treatment of patients with critical limb ischemia. Aastrom Biosciences is the REVIVE study sponsor.

Critical limb ischemia (CLI) is a severe, chronic cardiovascular disease causing severe obstruction of the arteries, which decreases blood flow to the extremities - specifically the hands, feet and legs. Symptoms include severe pain, skin ulcers, and sores in addition to “rest pain”, which patients often feel at night while lying horizontally. Individuals with peripheral arterial disease (PAD) often have critical limb ischemia, which needs immediate, comprehensive treatment by a vascular specialist or surgeon.

The UNC Center for Heart & Vascular Care is one of the two lead research sites for the clinical trial, along with Dartmouth/Mary Hitchcock Medical Center. According to Aastrom Biosciences, the REVIVE study will “assess the efficacy and safety of ixmyelocel-T in the treatment of no-option patients with critical limb ischemia.” Ixmyelocel-T is a patient-specific, multicellular therapy targeted to address the underlying causes of CLI. As the investigational treatment is an autologous stem cell therapy, bone marrow from the patients is treated with ixmyelocel-T then injected back into the patient. One of the many properties of ixmyelocel-T is tissue remodeling.

As the Division Chief for UNC Vascular Surgery, Dr. Marston is part of the REVIVE steering committee and is working in tandem with Dr. Joseph Fulton, Assistant Professor of Vascular Surgery at UNC and principal investigator for the REVIVE clinical trial. 80 treatment centers have qualified to enroll patients in the Phase 3 trial. 594 patients with CLI will be followed for 18 months. Patients accepted into this study have no option for revascularization, meaning the restoration of blood circulation to their extremities cannot be achieved through surgical means, and they also have existing tissue loss due to CLI. The primary endpoint of the trial will be amputation-free survival at 12 months.

Dr. Marston’s passion for limb preservation and wound care for his patients at UNC is evident through his involvement in the REVIVE trial. “If the treatment is successful," Marston says, "this study may lead to the first FDA approval for a stem cell product to treat cardiovascular disease.” By treating cardiovascular disease at a cellular level, it could lessen the need for future amputations on patients with CLI and other cardiovascular diseases. Joann Belanger, RN and Director of the UNC Wound Center, says, “Dr, Marston is reducing amputations by treating our patients’ chronic wounds using multiple non-surgical techniques.” Tim Mayleben, president and chief executive officer at Aastrom Biosciences says, “We are grateful to our investigators for their commitment to enrolling patients as quickly as possible in this important trial." Patients in the REVIVE study through the UNC Center for Heart & Vascular Care will continue to be treated through the end of 2013.

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