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Trial record 1 of 1 for:    02474121
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Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access (MOBILE-CA)

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ClinicalTrials.gov Identifier: NCT02474121
Recruitment Status : Available
First Posted : June 17, 2015
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Peripheral Vascular Diseases Critical Limb Ischemia Device: Bone marrow concentration device

Detailed Description:
This is a continued access enrollment intended for subjects with critical limb ischemia (CLI) that are unsuitable for revascularization. The investigational treatment utilizes autologous concentrated bone marrow aspirate (cBMA) at the point of care. The bone marrow aspirate is obtained from the subject's hip, concentrated with a bone marrow concentration device, and delivered intramuscularly to the affected limb. Subjects meeting the inclusion/exclusion criteria will be treated with the MarrowStim™ PAD Kit and followed for a total of five years. Information on subject outcomes, such as the occurrence of amputation and death, as well as measurements of rest pain, blood flow (ankle-brachial index, toe-brachial index), and quality of life will be collected. Safety information (via adverse event reporting) will also be collected.

Study Type : Expanded Access
Official Title: MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Bone marrow concentration device
    Collection of autologous bone marrow aspirate and point-of-care concentration using the bone marrow concentration device, followed by intramuscular injection of concentrated bone marrow aspirate (cBMA) into the affected limb
    Other Names:
    • MarrowStim™ PAD Kit
    • Bone Marrow Concentrate
    • Bone Marrow Mononuclear Cells

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474121

Contact: Ally Lawrence 574-372-6787 ally.lawrence@zimmerbiomet.com

United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Contact: Sandi Brock    501-257-6906    brocksandraj@uams.edu   
Principal Investigator: Mohammed Moursi, MD         
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Contact: Shan Liu    404-605-4098    Shan.Liu@piedmont.org   
Principal Investigator: Charles Ross, MD         
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Contact: Kristen Wanczyk    317-988-9548    keevans@iu.edu   
Principal Investigator: Michael Murphy, MD         
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Contact: Erica Tangney    617-636-8404    etangney@tuftsmedicalcenter.org   
Principal Investigator: Mark Iafrati, MD         
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Contact: Marion Cyriac, MD    201-530-7967    m-cyriac@mail.holyname.org   
Principal Investigator: John Rundback, MD         
United States, New York
The Mount Sinai Hospital
New York, New York, United States, 10029
Contact: Anusha Jayaram    212-241-8250    anusha.jayaram@mountsinai.org   
Principal Investigator: Ageliki Vouyouka, MD         
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States, 10065
Contact: Ruchita Mehta    646-962-8440    rum2006@med.cornell.edu   
Principal Investigator: Peter Connolly, MD         
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Larissa Schaaf, RN    216-444-5937    schaafl@ccf.org   
Principal Investigator: Rebecca Kelso, MD         
United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Contact: Jennifer Carrick    412-360-3653    jennifer.carrick@va.gov   
Principal Investigator: Edith Tzeng, MD         
United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Contact: Bevin Lopez    713-441-6537    balopez@houstonmethodist.org   
Principal Investigator: Eric Peden, MD         
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Contact: Robyn McKenzie    434-982-1058    rrm5f@virginia.edu   
Principal Investigator: Aditya Sharma, MD         
Sponsors and Collaborators
Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02474121     History of Changes
Other Study ID Numbers: BB-IDE 13996 (CA)
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases