MOBILE Study for Patients with Critical Limb Ischemia Caused by Severe Peripheral Arterial Disease

Protocol Title Peripheral Arterial Disease (PAD) - MOBILE Study for Patients with Critical Limb Ischemia Caused by Severe Peripheral Arterial Disease
Summary The MOBILE study is testing a new investigational device called MarrowStim™ PAD Kit. This strategy is designed to improve blood flow in legs with blocked arteries by attempting to treat diseased blood vessels. Because of the location and extent of the blockages in certain individuals, standard treatments such as surgical bypass (insertion of a vein or synthetic graft to redirect blood flow around the blockage) and angioplasty (insertion of a balloon through the artery to open the blockage) will not improve blood flow to the leg, and amputation is the only alternative.

The potential benefits of MarrowStim™ treatment include relief of pain, healing of ischemic ulcers, and limb salvage.

Only those patients meeting the pre-defined approved inclusion/exclusion criteria are eligible for this clinical trial.
Therapeutic Area Peripheral Arterial Disease (PAD)
Age Range 21 to No upper limit
Purpose The purpose of this research is to study the safety and effectiveness of an investigational treatment using a patient's own concentrated bone marrow aspirate in those suffering from severe peripheral arterial disease (PAD). The concentrated bone marrow aspirate is prepared using the MarrowStim™ Concentration Kit.

Concentrated bone marrow aspirate contains mononuclear cells that may have the potential to treat vascular structures. Study participants will receive multiple injections of concentrated bone marrow aspirate harvested from their iliac crest during ischemic limb surgery.
Who is Eligible? To participate you must:
  • be 21 years of age or older
  • been told by a doctor that you have severe blockage in the arteries of one or both of your lower legs
  • women of child-bearing potential must have a negative urine pregnancy test prior to enrolling into the study
Who is Not Eligible? You are not eligible if you:
  • have had a stroke or heart attack within the past 90 days
  • if you are currently pregnant

A study physician will discuss other exclusions with you.

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Trial Interests Allergies/Asthma
Alzheimer's Disease
Arthritis
Cancer
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Low Back Pain
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Restless Legs Syndrome - RLS
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“The concentrated bone marrow aspirate will be injected at several locations along the affected leg in an attempt to improve blood flow.”
“Injection of concentrated bone marrow aspirate prepared by the MarrowStim™ PAD Kit.”

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