FDA Clears Bone Marrow Injection Trial for Critical Limb Ischemia
February 1, 2011 – The U.S. Food and Drug Administration has approved a Phase I clinical trial to test a new technology for treating critical limb ischemia (CLI). The Investigational Device Exemption (IDE) allows Arteriocyte to test its Magellan MAR01 technology.
The technology uses concentrated marrow injections to improve perfusion in ischemic tissue in affected limbs of CLI patients who are not eligible for revascularization surgery.
It combines a rapid bedside tissue concentration device and sterile surgical disposables that produce platelet rich plasma from blood and bone marrow aspirations in approximately 15 minutes. The technology enables the rapid "closed system" concentration of aspirated bone marrow, yielding an injectable tissue rich in platelets, hematopoietic stem cells and mesenchymal stem cells, commonly viewed as key components in tissue repair. The company is developing it for use as a clinical treatment for CLI, and plans to initiate additional clinical trials evaluating the system in other applications during 2011.
Patient enrollment for the phase I safety study will begin immediately at The Ohio State University Medical Center (as the first clinical site), under the direction of Michael Go, M.D., assistant professor of surgery in the division of vascular diseases and surgery.
"This clinical trial represents a unique opportunity to evaluate a novel biologic treatment for 'no-option' CLI patients and reinforces Ohio State Medical Center's leadership role in the clinical evaluation of these important technologies to improve the delivery of care for our patients," he said.
CLI is caused by a severe blockage of peripheral arteries that significantly impairs blood flow to the extremities, causing chronic tissue degeneration and necrosis. It is estimated that 150,000 individuals lose a limb due to this disease each year.
"We're thrilled to have the green light to initiate this next important step in the clinical development program for the Magellan MAR01 technology,” said Don Brown, Arteriocyte CEO. It represents yet another achievement in our public-private partnership with Ohio's Third Frontier Program, and their support of our development of Magellan based cellular therapies for the treatment of cardiovascular and critical limb ischemia patients."
For more information: www.arteriocyte.com