Peripheral Arterial Disease Clinical Trial
Official title:
Use of Ixmyelocel-T (Formerly TRC Autologous Bone Marrow Cells) in Patients With Peripheral Arterial Disease to Treat Critical Limb Ischemia
This study is designed to evaluate the safety and efficacy of autologous Vascular Repair
Cells (VRC) for patients with peripheral arterial disease as a treatment for critical limb
ischemia.
The double-blind study is expected to enroll 150 patients, randomized into two patient
groups. The treatment group will receive intramuscular (IM) injections of the VRCs into the
affected limb; the control group will receive intramuscular injections with an electrolyte
solution (without cells). Both groups will receive the standard of care appropriate for their
medical condition.
The study will assess the safety and ability of Aastrom TRC autologous bone marrow cells to
restore peripheral blood flow affected by critical limb ischemia.
Peripheral arterial disease (PAD), also known as Peripheral Vascular Disease (PVD), occurs
when peripheral arteries are damaged by arterial hypertension and/or by the formation of
atherosclerotic plaques. PAD is a chronic disease that progressively constricts arterial
circulation of limbs. The term critical limb ischemia (CLI) is used for all patients with
chronic ischemia rest pain, ulcers, or gangrene in limbs attributable to objectively proven
PAD. These sequelae represent the end stage of PAD. PAD is associated with several other
clinical conditions, i.e. hypertension, cardiovascular disease, hyperlipidemia, diabetes,
tobacco use, obesity and stroke.
The double-blind study is expected to enroll 150 patients, randomized into two patient
groups. The treatment group will receive intramuscular injections of the TRC product into the
affected limb; the control group will receive intramuscular injections with an electrolyte
solution (without cells). Both groups will receive the standard of care appropriate for their
medical condition.
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