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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : April 3, 2020
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Sponsor:
Zimmer Biomet
Information provided by (Responsible Party):
Zimmer Biomet
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease | Device: Bone marrow concentration device Procedure: Placebo procedure (sham) | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 152 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD) |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | June 2016 |
| Estimated Study Completion Date : | September 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Peripheral Arterial Disease
| Arm | Intervention/treatment |
|---|---|
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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
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Device: Bone marrow concentration device
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Other Names:
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Sham Comparator: Placebo control (sham)
Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
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Procedure: Placebo procedure (sham)
Sham bone marrow aspiration, sham delivery to affected limb |
Primary Outcome Measures :
- Time to treatment failure [ Time Frame: 52 weeks ]"Treatment failure" defined as the composite of major amputation of the index limb or death
Secondary Outcome Measures :
- 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
Other Outcome Measures:
- 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
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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): NCT01049919
Locations
Show 25 study locations
Sponsors and Collaborators
Zimmer Biomet
Investigators
| Principal Investigator: | Michael P. Murphy, MD | Indiana University School of Medicine |
Publications:
| Responsible Party: | Zimmer Biomet |
| ClinicalTrials.gov Identifier: | NCT01049919 |
| Other Study ID Numbers: |
BB-IDE 13996 BBIO.CR.CT002 ( Other Identifier: Biomet ) |
| First Posted: | January 15, 2010 Key Record Dates |
| Last Update Posted: | April 3, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 |
Keywords provided by Zimmer Biomet:
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Peripheral Arterial Disease Peripheral Vascular Disease Stem Cells Cell Therapy Critical Limb Ischemia CLI |
PAD PVD Angiogenesis Limb Salvage Amputation Leg Pain |
Additional relevant MeSH terms:
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Vascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Ischemia Pathologic Processes |
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |