Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI) (MOBILE)

Tracking Information
First Submitted Date ICMJE	January 14, 2010
First Posted Date ICMJE	January 15, 2010
Last Update Posted Date	June 23, 2017
Study Start Date ICMJE	June 2010
Actual Primary Completion Date	June 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 27, 2010)	Time to treatment failure [ Time Frame: 52 weeks ]; "Treatment failure" defined as the composite of major amputation of the index limb or death
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01049919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 27, 2010)	Perfusion and quality of life measurements [ Time Frame: Throughout 52 week follow-up ]; ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, minor amputations, time to major amputation of the index limb, time to death
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE; (submitted: May 12, 2014)	Long-term treatment failure [ Time Frame: 5 years ]Evaluations of long-term amputation-free survival will be assessed for a period of 5 years.; Long-term perfusion and quality of life measurements [ Time Frame: 3 years ]ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, SF-36, wound assessment, minor amputations, time to major amputation of the index limb, time to death
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
Official Title ICMJE	MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
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).
Detailed Description	This is a prospective, randomized, double-blind, placebo controlled, multicenter trial 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 randomized to receive either the investigational treatment (cBMA) or a placebo control (sham treatment).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Critical Limb Ischemia; Peripheral Arterial Disease; Peripheral Vascular Disease
Intervention ICMJE	Device: Bone marrow concentration device Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb Other Names: Bone marrow concentrate Bone marrow mononuclear cells MarrowStim; Procedure: Placebo procedure (sham) Sham bone marrow aspiration, sham delivery to affected limb
Study Arms	Experimental: Concentrated bone marrow aspirate (cBMA) 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 Intervention: Device: Bone marrow concentration device; Sham Comparator: Placebo control (sham) Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb Intervention: Procedure: Placebo procedure (sham)
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Estimated Enrollment ICMJE; (submitted: September 27, 2010)	152
Original Enrollment ICMJE	Not Provided
Estimated Study Completion Date	May 2020
Actual Primary Completion Date	June 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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) 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) Exclusion Criteria: 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; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01049919
Other Study ID Numbers ICMJE	BB-IDE 13996; BBIO.CR.CT002 ( Other Identifier: Biomet )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: Yes Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Zimmer Biomet
Study Sponsor ICMJE	Zimmer Biomet
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine
PRS Account	Zimmer Biomet
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP