Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Disease
1 other identifier
interventional
97
1 country
34
Brief Summary
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of this study is to determine if injections of concentrated bone marrow into damaged tissues will result in improved blood flow. If successful, this treatment could improve blood flow to the lower limb, reduce pain, and reduce the frequency of limb amputations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
November 22, 2010
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 15, 2015
December 1, 2015
4.3 years
November 18, 2010
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amputation Free Survival
Survival without a major (above the ankle) amputation
Six Months
Secondary Outcomes (2)
Change In Rutherford Classification
Six Months
Change in Pain
Six Months
Study Arms (2)
BMAC Treatment
ACTIVE COMPARATORIntervention- Injection of 40 ml of autologous bone marrow concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
Placebo Injection
PLACEBO COMPARATORInjection of placebo (diluted peripheral blood) into ischemic tissue of the lower extremity
Interventions
Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
Injection of placebo into ischemic tissue of the lower extremity
Eligibility Criteria
You may qualify if:
- Patient has Peripheral Arterial Occlusive Disease (PAOD) with clinical Rutherford Category 5 disease, as defined in the reporting standards adopted by the Society of Vascular Surgeons(table 1); Minor Tissue loss-focal gangrene with diffuse pedal ischemia
- Patient meets at least one of the following diagnostic criteria in the study limb:
- Ankle artery occlusion pressure absolute ≤60 mmHg or ABI ≤0.6
- Toe artery occlusive pressure \< 50mm Hg or TBI ≤0.6
- There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
- Anatomical considerations
- No outflow targets
- No appropriate conduit (i.e. vein for bypass)
- Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
- High risk medical conditions i.e. Unstable cardiac disease.
- History of prior failed revascularization attempts
- The Patient's case was reviewed at the treating institution's Multidisciplinary Vascular Conference where the patient's status as a poor candidate for conventional therapies was confirmed.
- Age ≥18 years and ability to understand the planned treatment
- Subject has read and signed the IRB approved Informed Consent form
- Patients for whom the following medication(s) is prescribed must have a one month stable baseline therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication. If any of these medications are not prescribed notation of the reason for omission is to be provided.
- +1 more criteria
You may not qualify if:
- Life expectancy \<6 months due to concomitant illnesses
- History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
- Terminal renal failure with existing dependence on dialysis or serum creatinine \>2.5 mg/dL
- Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free.
- Poorly controlled diabetes mellitus (HgbA1C\>10%)
- Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
- Life-threatening complications of the ischemia necessitating immediate amputation
- Uncorrected occlusion of the common or external iliac artery on index side
- Absence of any pulsatile Doppler flow below the ankle.
- Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6).
- Ulceration with exposed bone proximal to the distal metatarsal heads (ie. heel or mid foot)
- Active clinical infection or infection being treated by antibiotics within one week of enrollment
- Treatment with immunosuppressant drugs (including Prednisone \> 5 mg per day).
- Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
- Underwent a major open cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or a myocardial infarction within the 3 months prior to randomization
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of Alabama
Birmingham, Alabama, 35294-0012, United States
Medical Center of South Arkansas
El Dorado, Arkansas, 71730, United States
USC Keck School of Medicine
Los Angeles, California, 90033, United States
Florida Hospital - Vascular Institute of Central Florida
Orlando, Florida, 32804, United States
Coastal Vascular & Interventional
Pensacola, Florida, 32503, United States
USF / Tampa General
Tampa, Florida, 33606, United States
University of Illinois-Chicago
Chicago, Illinois, 60612, United States
Cadence Health, Central DuPage Hospital
Winfield, Illinois, 60190, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Maine Medical Ctr
Portland, Maine, 04102, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess
Boston, Massachusetts, 02215, United States
Kansas City Vascular
Kansas City, Missouri, 64116, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Dartmouth Hitchcock Medical Ctr
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
North Shore-Long Island Jewish
Lake Success, New York, 11042, United States
St. Luke's Roosevelt
New York, New York, 10025, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Regional Infectious Disease and Infusion Ctr
Lima, Ohio, 45801, United States
University of Oklahoma
Tulsa, Oklahoma, 74135, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Roper St Francis Medical Center
Charleston, South Carolina, 29401, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Baylor Medical Ctr
Dallas, Texas, 75226, United States
University of Texas - Houston Medical School
Houston, Texas, 77030, United States
Peace Health Southwest Medical Center
Vancouver, Washington, 98682, United States
Charleston Area Medical Center Institute
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Iafrati, MD
Tufts Medical Ctr
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2010
First Posted
November 22, 2010
Study Start
May 1, 2011
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
December 15, 2015
Record last verified: 2015-12