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Holy Cross Hospital Taking Part in Research Study to Evaluate Cell Therapy for Severe Cardiovascular Disease

Researchers using cells from a patient’s own bone marrow to treat critical limb ischemia

Michael Rush M.D. and Charles Tate M.D., at Holy Cross Hospital, have initiated patient enrollment in a national research study using an investigational cell therapy to treat patients with critical limb ischemia (CLI), a severe form of peripheral arterial disease (PAD) that can restrict blood flow to the arms and legs and can often lead to amputation.

In the study, researchers will use cells from a patient’s own bone marrow to develop a cell therapy to treat CLI. In the study, known as the REVIVE Phase 3 Clinical Trial, patients will be treated with placebo or ixmyelocel-T, an investigational regenerative medicine developed by Aastrom Biosciences. Ixmyelocel-T is a patient-specific (autologous) medicine where cells are cultured and expanded from a patient’s bone marrow.

"Up to 40 percent of CLI patients are not candidates for surgery and, if successful, this approach could lead to a new treatment option that can potentially result in a tremendous difference to a patient's quality of life," said Michael Rush MD, principal investigator at the site. 

The physicians at Holy Cross are currently recruiting study participants. The REVIVE study is for patients who have no options for surgical treatment to restore blood flow and are facing an amputation. REVIVE is the largest randomized, double-blind, placebo-controlled study ever conducted in patients with CLI. The primary endpoint of the REVIVE trial is amputation free survival at 12 months.

For more information about the REVIVE study, please visit www.revivecli.com If you are interested in participating in this study please contact Cyndi Toot ARNP at 954-267-6626 or cynthia.toot@holy-cross.com.

About Critical Limb Ischemia (CLI)

Peripheral arterial disease (PAD) is a chronic disease that progressively restricts blood flow in the limbs and can lead to serious medical complications. This disease is often associated with other clinical conditions, including hypertension, cardiovascular disease, hyperlipidemia, diabetes, obesity and stroke. The term critical limb ischemia (CLI) is used to describe patients with chronic ischemia-induced pain (even at rest), ulcers, tissue loss or gangrene in the limbs. CLI is the most severe form of PAD, and is typically the end stage of the disease. Patients suffering from this condition are critically ill, with a high risk of amputation. These patients are extremely limited in their ambulatory capacity and experience constant and chronic ischemia-induced pain, ulcers, tissue loss or gangrene to the limbs, which can lead to amputations. Among CLI patients with no option for revascularization, 20 percent to 40 percent will undergo a major amputation within 6 months to a year of diagnosis.

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