Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI) (MOBILE)
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ClinicalTrials.gov Identifier: NCT01049919 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 15, 2010
Last Update Posted
: June 23, 2017
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Sponsor:
Zimmer Biomet
Information provided by (Responsible Party):
Zimmer Biomet
Tracking Information | |||||||
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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 |
Time to treatment failure [ Time Frame: 52 weeks ] "Treatment failure" defined as the composite of major amputation of the index limb or death
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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 |
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
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | ||||||
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 ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Zimmer Biomet | ||||||
Study Sponsor ICMJE | Zimmer Biomet | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |