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

Description

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.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Device: Bone marrow concentration device

Specialties

  • Cardiology: Vascular Medicine
  • Internal Medicine: Vascular Medicine

MeSH Terms

  • Atherosclerosis
  • Ischemia
  • Vascular Diseases

Study ID

Biomet, Inc. -- BB-IDE 13996 (CA)

Status

Available

Trial ID

NCT02474121

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Biomet, Inc.

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Holy Name Medical Center - Teaneck, New Jersey 45.7 miles None None None
Tufts Medical Center - Boston, Massachusetts 137.7 miles None None None
VA Pittsburgh Healthcare System - Pittsburgh, Pennsylvania 355.7 miles None None None
Piedmont Hospital - Atlanta, Georgia 798.5 miles None None None
Central Arkansas Veterans Healthcare System - Little Rock, Arkansas 1,131.5 miles None None None
Houston Methodist Hospital - Houston, Texas 1,475.7 miles None None None

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