Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access

NO_LONGER_AVAILABLE

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia

In brief

This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.

Key facts

Study ID

NCT02474121

Run by

Zimmer Biomet

Last updated by the study team

2020-03-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial disease
• Unsuitable for revascularization
• Minor tissue loss (Rutherford Category 5) or ischemic rest pain (Rutherford Category 4)
• Competent to give consent
• No current malignancy or history of previous malignancy within the last five years, with the exception of adequately treated non-melanoma skin cancer (evidence of standard preventative cancer screenings required)

You may not qualify if…

• Major tissue loss (Rutherford Category 6)
• Diabetics with uncontrolled or untreated proliferative retinopathy
• Poorly controlled diabetes mellitus with HbA1C > 10%
• Uncompensated congestive heart failure and/or other conditions that preclude general anesthesia
• Myocardial infarction or stroke within last 90 days
• Elevated liver function tests (AST or ALT more than twice the upper limit of normal)
• Renal disease (creatinine > 2.5 mg/dl) or chronic hemodialysis
• White blood cell count < 3,000/µL or > 15,000/µL, platelet count < 100,000/µL, or hematocrit < 32%
• Topical growth hormone therapy within last 90 days, or injected growth hormone therapy within last 180 days
• Disease of central nervous system and/or other conditions that impair cognitive function
• Two or more episodes of pulmonary embolus with a documented DVT in index leg or history of DVT in index leg without evidence of clot resolution
• Current infection of index leg
• Pregnant women (negative urine pregnancy test required)
• Lower extremity venous disease with pitting edema in index leg
• Recent history (in the 6 months prior to screening) of bone marrow disease or treatment with any medication or procedure which adversely affects the bone marrow and would prohibit transplantation
• Current osteomyelitis in index leg
• Existing HIV diagnosis
• Organ transplant recipients
• Known terminal disease process with life expectancy less than one year
• Severe concomitant disease(s) or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject
• Major amputation required within 30 days
• Inclusion in any other clinical study that may affect the outcome of this study
• Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac artery and/or common femoral artery of the index leg.

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• The Mount Sinai Hospital — New York, New York, United States
• Weill Cornell Medical College/New York Presbyterian Hospital — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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