Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT00498069
First received: July 5, 2007
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis


Condition Intervention
Ischemia
Device: Harvest Smartprep2 BMAC System
Device: SmartPReP2 BMAC System
Biological: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease

Further study details as provided by Harvest Technologies:

Primary Outcome Measures:
  • To be determined by data from this feasibility study [ Time Frame: 3 mos & 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2007
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Injection of autologous bone marrow concentrate into ischemic tissues of the lower extremity
Device: Harvest Smartprep2 BMAC System
injection of 40cc bmac
Other Name: SmartPReP2 BMAC System
Device: SmartPReP2 BMAC System
Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
Other Name: SmartPReP2 BMAC System
Placebo Comparator: 2
Injection of placebo into ischemic tissues of the lower extremity
Biological: placebo
injection of placebo into ischemic tissue of the lower extremity

Detailed Description:

Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The buffy coat is concentrated by removing plasma. The resultant concentrate of cells is injected into ischemic tissues of the lower limb.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Critical Limb Ischemia per protocol (see diagnostic criteria #2) with regard to the study limb.

Existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 or Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons (table 1)

  • Patient meets at least one of the following diagnostic criteria in the study limb:

    • Ankle artery occlusion pressure absolute <50 mmHg or ABI <0.4
    • Toe artery occlusive pressure < 40mm Hg or TBI (<0.4)
    • TcPO2 <20 mmHg lying down breathing room air.
  • 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

      • Unstable cardiac disease.
      • Renal insufficiency
    • History of prior failed revascularization attempts
    • The patient's unsuitability must be confirmed by 2 qualified physicians.

      • The attending vascular surgeon will provide the primary assessment.
      • The confirmatory opinion must come from a fully licensed physician. (not a resident)
      • If anatomical considerations are invoked, the second physician may be a vascular surgeon, interventional radiologist, cardiologist, or vascular medicine specialist.
      • If medical co-morbidity is deemed the high risk aspect, then the confirmatory opinion may be obtained from an internist, family physician, cardiologist, vascular medicine, nephrologists, or vascular surgeon.
  • 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 of appropriate/maximally tolerated therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication
  • Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 2.0 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:

  • 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
  • Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult 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 iliac artery occlusion on index side
  • No Doppler signal in the foot (ABI =0)
  • Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
  • Active clinical 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
  • Cerebrovascular accident within 6 months prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498069

Locations
United States, Florida
University of South Florida Department of Vascular Surgery at Tampa General
Tampa, Florida, United States, 33606
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
The Vascular Group at Albany Medical Center
Albany, New York, United States, 12208
Maimonides Medical Center
Brooklyn, New York, United States, 11219
United States, South Carolina
Roper St. Francis Hospital
Charleston, South Carolina, United States, 29401
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Harvest Technologies
  More Information

No publications provided

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT00498069     History of Changes
Other Study ID Numbers: 2007-1
Study First Received: July 5, 2007
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Harvest Technologies:
CLI
PAOD
Bone marrow aspirate
Bone marrow concentrate
Critical limb ischemia due to peripheral arterial occlusive disease
PAD
Autologous bone marrow concentrate

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Ischemia
Peripheral Arterial Disease
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014