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Pivotal Study

Summary of Trial: 
 
Eligible candidates must have Rutherford Stage 5 disease (non-healing ulcer) and no reasonable open or endovascular options for revascularization. A bone marrow aspirate will be performed and the aspirate spun to retrieve endothelial progenitor cells which will then be injected into the ischemic limb to stimulate angiogenesis.
Principal Investigator:Bruce Perler, MD
Study Coordinator:

Kathryn Hines
Email: khines5@jhmi.edu

Study Long Title: 

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 Occlusive Disease

JHU IRB Number:

00047821

Important Inclusion Criteria:
  1. 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
  2. Patient meets at least one of the following diagnostic criteria in the study limb:
    1. Ankle artery occlusion pressure absolute ≤60 mmHg or ABI ≤0.5
    2. Toe artery occlusive pressure < 50mm Hg or TBI ≤0.5
    3. TcPO2 ≤30 mmHg on the dorsum of the foot, lying down breathing room air.
  3. 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:
    1. Anatomical considerations
      1. No outflow targets
      2. No appropriate conduit (i.e. vein for bypass)
      3. Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
    2. High risk medical conditions,  i.e. Unstable cardiac disease.
    3. History of prior failed revascularization attempts
    4. The patient’s unsuitability will be attested to by the attending vascular surgeon.
  1. All candidates for this study must be presented for consideration at the treating institution's Multidisciplinary Vascular Conference where the patient’s status as a poor candidate for conventional open end endovascular therapies will be discussed. If other staff members believe that the patient would be a reasonable candidate for a conventional intervention then this dissenting opinion must be noted by the local PI. The case should then be submitted to the overall multicenter Lead Investigator to adjudicate study eligibility.
  1. Age >18 years and ability to understand the planned treatment
  2. Subject has read and signed the IRB approved Informed Consent form
  3. Patients for whom the following medication(s) is prescribed must have a one month stable baseline of appropriate/maximally tolerated therapy prior to enrollment: Antiplatelet therapy (i.e. aspirin, Plavix), cholesterol lowering agent, -blockers, and/or blood pressure medication. If any of these medications are not prescribed notation of the reason for omission is to be provided.
  4. 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.
Important Exclusion Criteria:
  1. Life expectancy <6 months due to concomitant illnesses
  2. History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
  3. Renal failure with existing dependence on dialysis or serum creatinine >2.5 mg/dL
  4. 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.
  5. Poorly controlled diabetes mellitus (HgbA1C>10%)
  6. Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
  7. Life-threatening complications of the ischemia necessitating immediate amputation
  8. Uncorrected iliac artery occlusion on index side
  9. No Doppler signal in the foot (ABI =0)
  10. Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6).
  11. Ulceration with exposed bone proximal to the distal metatarsal heads (i.e. heel or mid foot)
  12. Active clinical infection or infection being treated by antibiotics within one week of enrollment
  13. Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day).
  14. Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
  15. 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
  16. Underwent a successful or partially successful endovascular intervention for peripheral arterial occlusive disease. (i.e. Aorta, iliac, femoral, popliteal, or tibial artery angioplasty, stenting, or atherectomy) within the prior 3 months.
  17. Endovascular coronary intervention (i.e. Angioplasty, atherectomy, stenting) within 1 month prior to randomization.
  18. Underwent a failed attempt for endovascular revascularization during the prior 1 month. For the purpose of this exclusion criteria an endovascular procedure is considered a failure if: 1) No therapeutic intervention performed, 2) The treated artery recoils, thrombosis, 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.
  19. Cerebrovascular accident within 6 months prior to randomization.
  20. Treatment with topical growth factors or hyperbaric oxygen (HBO) within 30 days, or systemic growth factor treatment within 6 months of enrollment.
Clinical Trial Site: 

Johns Hopkins Hospital
600 N. Wolfe St
Baltimore, MD 21287

There are 25 investigational sites in the United States.

Start Date:3/10/11
Anticipated End Date:Two years from first patient enrollment
Compensation for Participating: None
Currently Enrolling?Yes
More Information:http://clinicaltrials.gov/ct2/show/NCT00498069?term=Autologous+Bone+and+harvest&rank=1
 

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