Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
NCT ID: NCT01245335
Last Updated: 2015-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
97 participants
INTERVENTIONAL
2011-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMAC Treatment
Intervention- Injection of 40 ml of autologous bone marrow concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
BMAC injection
Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
Placebo Injection
Injection of placebo (diluted peripheral blood) into ischemic tissue of the lower extremity
Placebo injection
Injection of placebo into ischemic tissue of the lower extremity
Interventions
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BMAC injection
Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
Placebo injection
Injection of placebo into ischemic tissue of the lower extremity
Eligibility Criteria
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Inclusion Criteria
* 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.
* Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 2.5 mg / dL, INR ≤ 1.6 unless on Coumadin, or PTT \<1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR\<1.6 at the time of randomization/surgery.
Exclusion Criteria
* 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
* Underwent a successful or partially successful endovascular intervention for peripheral arterial occlusive disease. (ie. Aorta, iliac, femoral, popliteal, or tibial artery angioplasty, stenting, or atherectomy) within the prior 3 months.
* Endovascular coronary intervention (ie. Angioplasty, atherectomy, stenting) within 1 month prior to randomization.
1. The procedure is diagnostic only with no intervention performed, (for example in the case where wire crossing can not be obtained).
2. The treated artery recoils, thromboses, or dissects resulting in occlusion of the treated arterial segment, documented by intraoperative imaging. Note that endovascular procedures with suboptimal results but not meeting criteria 1 or 2 above may qualify for inclusion after 3 months as in #16 above.
* Cerebrovascular accident within 6 months prior to randomization.
* Treatment with topical growth factors or hyperbaric oxygen (HBO) within 30 days, or systemic growth factor treatment within 6 months of enrollment.
* Known hypersensitivity to heparin; or history of heparin-induced thrombocytopenia (HIT).
18 Years
ALL
No
Sponsors
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Harvest Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Iafrati, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Ctr
Locations
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University of Alabama
Birmingham, Alabama, United States
Medical Center of South Arkansas
El Dorado, Arkansas, United States
USC Keck School of Medicine
Los Angeles, California, United States
Florida Hospital - Vascular Institute of Central Florida
Orlando, Florida, United States
Coastal Vascular & Interventional
Pensacola, Florida, United States
USF / Tampa General
Tampa, Florida, United States
University of Illinois-Chicago
Chicago, Illinois, United States
Cadence Health, Central DuPage Hospital
Winfield, Illinois, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Maine Medical Ctr
Portland, Maine, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Kansas City Vascular
Kansas City, Missouri, United States
Mercy Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Ctr
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
North Shore-Long Island Jewish
Lake Success, New York, United States
St. Luke's Roosevelt
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Regional Infectious Disease and Infusion Ctr
Lima, Ohio, United States
University of Oklahoma
Tulsa, Oklahoma, United States
Oregon Health Science University
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Roper St Francis Medical Center
Charleston, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
University of Tennessee
Knoxville, Tennessee, United States
Baylor Medical Ctr
Dallas, Texas, United States
University of Texas - Houston Medical School
Houston, Texas, United States
Peace Health Southwest Medical Center
Vancouver, Washington, United States
Charleston Area Medical Center Institute
Charleston, West Virginia, United States
Countries
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Other Identifiers
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CLI-2011-1
Identifier Type: -
Identifier Source: org_study_id