Critical Limb IschemiaMOBILENCT01049919
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
A study testing Bone marrow concentration device in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Zimmer Biomet at 25 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- What is being tested?
- Bone marrow concentration device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 25 sitesUnited States
- Study dates
- Jun 2010to Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 23Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Tufts Medical Center
Boston, Massachusetts, 02111
University of Virginia Hospital
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic
Cleveland, Ohio, 44195
Remington-Davis
Columbus, Ohio, 43215
Spectrum Health
Grand Rapids, Michigan, 49503
The Methodist Hospital
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Saint Luke's Hospital
Kansas City, Missouri, 64111
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
University of Louisville
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
The Mount Sinai Hospital
New York, New York, 10029
Weill Cornell Medical College / New York-Presbyterian Hospital
New York, New York, 10065
Nebraska-Western Iowa VA Healthcare System
Omaha, Nebraska, 68105
Temple University Hospital
Philadelphia, Pennsylvania, 19140
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
University of California-Davis Medical Center
Sacramento, California, 95817
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Holy Name Medical Center
Teaneck, New Jersey, 07666
UMass Memorial Health Care
Worcester, Massachusetts, 01655
About this study
Official title: MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
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).
Read the 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).
- Being tested
- Bone marrow concentration device, Placebo procedure (sham)
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease, CLI, PAD, PVD, Angiogenesis, Stem Cells, Cell Therapy, Limb Salvage, Amputation, Leg Pain
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow concentration deviceDevice
Also called Bone marrow concentrate, Bone marrow mononuclear cells, MarrowStim
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Placebo procedure (sham)Procedure or surgery
Sham bone marrow aspiration, sham delivery to affected limb
| Study group | Role | What they receive |
|---|---|---|
| Concentrated bone marrow aspirate (cBMA) | Experimental | 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 Receives: Device: Bone marrow concentration device |
| Placebo control (sham) | Sham comparator | Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb Receives: Procedure: Placebo procedure (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Major Amputation or Death
Occurrence of major amputation (above the ankle joint) or death.
Measured: 52 weeks
Secondary outcomes (2)
Visual Analog Scale (VAS) - Pain
Pain reported at the 52-week follow-up visit as assessed on the visual analog scale (VAS). Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance from the beginning of the line is measured and reported in centimeters (cm), with 0 representing no pain and 10 representing the worst possible pain.
Measured: 52 weeks
Six-Minute Walk Test
Measurement (in meters) of the total distance a participant is able to walk in 6 minutes. Since ability to walk is related to the condition of the affected limb, this measure is tied to limb pain and function. If a participant had multiple limbs included in the study, each limb was evaluated separately. Only one limb could be included in the study at a time.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2016
- Study completionFeb 2020
Why it stopped: Primary endpoint not met, remaining long-term follow-up not needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael P. Murphy, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049919
- Sponsor's protocol ID
- BB-IDE 13996
- Other IDs
- BBIO.CR.CT002
- Acronym
- MOBILE
- Status last verified
- May 2021
- First submitted
- 14 Jan 2010
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 21514773
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT01049919
- Acronym / sponsor ID
- MOBILE / BB-IDE 13996
- Keywords
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease, CLI, PAD, PVD, Angiogenesis, Stem Cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint not met, remaining long-term follow-up not needed.
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated bone marrow aspirate (cBMA) | Experimental | Device: Bone marrow concentration deviceCollection 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 comparator | Procedure: Placebo procedure (sham)Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow concentration deviceAlso: Bone marrow concentrate, Bone marrow mononuclear cells, MarrowStimConcentration of autologous bone marrow aspirate for intramuscular delivery to affected limb | Device | Concentrated bone marrow aspirate (cBMA) |
| Placebo procedure (sham)Sham bone marrow aspiration, sham delivery to affected limb | Procedure or surgery | Placebo control (sham) |
Primary outcome
Occurrence of Major Amputation or Death
Time frame: 52 weeks
Occurrence of major amputation (above the ankle joint) or death.
2 secondary outcomes
Visual Analog Scale (VAS) - Pain
Time frame: 52 weeks
Six-Minute Walk Test
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21514773Murphy 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.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Limb Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Murphy, MD principal investigator
Indiana University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow concentration device in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Zimmer Biomet at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Major Amputation or Death (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.