Study Stopped
Primary endpoint not met, remaining long-term follow-up not needed.
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
MOBILE
MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
2 other identifiers
interventional
153
1 country
25
Brief Summary
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedResults Posted
Study results publicly available
May 28, 2021
CompletedMay 28, 2021
May 1, 2021
6 years
January 14, 2010
January 22, 2021
May 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Major Amputation or Death
Occurrence of major amputation (above the ankle joint) or death.
52 weeks
Secondary Outcomes (2)
Visual Analog Scale (VAS) - Pain
52 weeks
Six-Minute Walk Test
52 weeks
Other Outcomes (1)
Occurrence of Major Amputation or Death
5 years
Study Arms (2)
Concentrated bone marrow aspirate (cBMA)
EXPERIMENTALCollection 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
Placebo control (sham)
SHAM COMPARATORPlacebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
Interventions
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Sham bone marrow aspiration, sham delivery to affected limb
Eligibility Criteria
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) with ABI ≤ 0.6, or TBI ≤ 0.4, or TcPO2 ≤ 50 mm Hg
- 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 on oral or insulin therapy with uncontrolled or untreated proliferative retinopathy (evidence of retinal exam required)
- Poorly controlled diabetes mellitus with HbA1C \> 10% (evidence of HbA1C test required)
- Uncompensated congestive heart failure (New York Heart Association Class IV) 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 normal upper limit)
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (25)
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
University of California-Davis Medical Center
Sacramento, California, 95817, United States
University of Miami
Miami, Florida, 33136, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
UMass Memorial Health Care
Worcester, Massachusetts, 01655, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Nebraska-Western Iowa VA Healthcare System
Omaha, Nebraska, 68105, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Weill Cornell Medical College / New York-Presbyterian Hospital
New York, New York, 10065, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Remington-Davis
Columbus, Ohio, 43215, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia Hospital
Charlottesville, Virginia, 22908, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 21514773BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hillary Overholser
- Organization
- Zimmer Biomet
Study Officials
- PRINCIPAL INVESTIGATOR
Michael P. Murphy, MD
Indiana University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 15, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2016
Study Completion
February 1, 2020
Last Updated
May 28, 2021
Results First Posted
May 28, 2021
Record last verified: 2021-05