Peripheral Arterial DiseaseMOBILE-CANCT02474121
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
A study testing Bone marrow concentration device in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Zimmer Biomet at 9 sites in United States.
Trial summary
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia
- What is being tested?
- Bone marrow concentration device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- 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)
- 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 with uncontrolled or untreated proliferative retinopathy
- Poorly controlled diabetes mellitus with HbA1C > 10%
- Uncompensated congestive heart failure 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 the upper limit of normal)
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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Tufts Medical Center
Boston, Massachusetts, 02111
Cleveland Clinic
Cleveland, Ohio, 44195
Indiana University
Indianapolis, Indiana, 46202
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
The Mount Sinai Hospital
New York, New York, 10029
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Holy Name Medical Center
Teaneck, New Jersey, 07666
About this study
Official title: MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
Read the detailed description
This is a continued access enrollment 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 treated with the MarrowStim™ PAD Kit and followed for a total of five years. Information on subject outcomes, such as the occurrence of amputation and death, as well as measurements of rest pain, blood flow (ankle-brachial index, toe-brachial index), and quality of life will be collected. Safety information (via adverse event reporting) will also be collected.
- Being tested
- Bone marrow concentration device
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
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 MarrowStim™ PAD Kit, Bone Marrow Concentrate, Bone Marrow Mononuclear Cells
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474121
- Sponsor's protocol ID
- BB-IDE 13996 (CA)
- Acronym
- MOBILE-CA
- Status last verified
- Mar 2020
- First submitted
- 15 Jun 2015
- Last updated
- 27 Mar 2020
- Results posted
- No
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 21514773Wang SK, Green LA, Gutwein AR, Drucker NA, Babbey CM, Gupta AK, Fajardo A, Motaganahalli RL, Wilson MG, Murphy MP. Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites. J Vasc Surg. 2018 Aug;68(2):560-566. doi: 10.1016/j.jvs.2017.11.088. Epub 2018 Mar 1.
PubMed 29503004
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. 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) (MOBILE) - Continued Access
- ClinicalTrials.gov ID
- NCT02474121
- Acronym / sponsor ID
- MOBILE-CA / BB-IDE 13996 (CA)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
Detailed description
This is a continued access enrollment 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 treated with the MarrowStim™ PAD Kit and followed for a total of five years. Information on subject outcomes, such as the occurrence of amputation and death, as well as measurements of rest pain, blood flow (ankle-brachial index, toe-brachial index), and quality of life will be collected. Safety information (via adverse event reporting) will also be collected.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- 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)
- 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 with uncontrolled or untreated proliferative retinopathy
- Poorly controlled diabetes mellitus with HbA1C > 10%
- Uncompensated congestive heart failure 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: MarrowStim™ PAD Kit, Bone Marrow Concentrate, Bone Marrow Mononuclear CellsCollection 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 | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- 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.
- Derived from this study: PubMed 29503004Wang SK, Green LA, Gutwein AR, Drucker NA, Babbey CM, Gupta AK, Fajardo A, Motaganahalli RL, Wilson MG, Murphy MP. Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites. J Vasc Surg. 2018 Aug;68(2):560-566. doi: 10.1016/j.jvs.2017.11.088. Epub 2018 Mar 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Zimmer Biomet at 9 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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474121, which also lists 2 linked publications.
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 27 Mar 2020.