- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02474121
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access (MOBILE-CA)
March 26, 2020 updated by: Zimmer Biomet
MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access
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 Overview
Status
No longer available
Intervention / Treatment
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Healthcare System
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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New Jersey
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Teaneck, New Jersey, United States, 07666
- Holy Name Medical Center
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New York
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New York, New York, United States, 10029
- The Mount Sinai Hospital
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New York, New York, United States, 10065
- Weill Cornell Medical College/New York Presbyterian Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Murphy MP, Lawson JH, Rapp BM, Dalsing MC, Klein J, Wilson MG, Hutchins GD, March KL. Autologous bone marrow mononuclear cell therapy is safe and promotes amputation-free survival in patients with critical limb ischemia. J Vasc Surg. 2011 Jun;53(6):1565-74.e1. doi: 10.1016/j.jvs.2011.01.074. Epub 2011 Apr 22.
- Wang SK, Green LA, Gutwein AR, Drucker NA, Babbey CM, Gupta AK, Fajardo A, Motaganahalli RL, Wilson MG, Murphy MP. Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites. J Vasc Surg. 2018 Aug;68(2):560-566. doi: 10.1016/j.jvs.2017.11.088. Epub 2018 Mar 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 15, 2015
First Submitted That Met QC Criteria
June 15, 2015
First Posted (Estimate)
June 17, 2015
Study Record Updates
Last Update Posted (Actual)
March 27, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB-IDE 13996 (CA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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