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Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595257
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
Harvest Technologies

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE January 16, 2008
Last Update Posted Date March 9, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
avoid amputation [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
measurement of hemodynamic response [ Time Frame: 60 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
Official Title  ICMJE Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Non Reconstructable Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
Brief Summary The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arterial Occlusive Diseases
Intervention  ICMJE Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
Other Name: SmartPReP2 BMAC System
Study Arms  ICMJE
  • Experimental: 1
    injection of BMAC into ischemic limb
    Intervention: Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
  • Active Comparator: 2
    Injection and Infusion of BMAC into ischemic lower limb
    Intervention: Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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)

  2. 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, if available.
  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:

    • 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.
  4. Age >18 years and ability to understand the planned treatment
  5. Subject has read and signed the IRB/IEC approved Informed Consent form
  6. 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
  7. Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, 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:

  1. Life expectancy <6 months due to concomitant illnesses
  2. History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
  3. Terminal renal failure with existing dependence on dialysis
  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. Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
  10. Active clinical infection being treated by antibiotics within one week of enrollment
  11. Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day).
  12. Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
  13. Underwent a major cardiovascular surgical procedure (carotid endarterectomy, open arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or an adverse cardiovascular event (stroke or MI) within the 30 days prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00595257
Other Study ID Numbers  ICMJE TriCell/CT/IND-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harvest Technologies
Study Sponsor  ICMJE Harvest Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: R E Arasan, MD LifeCell India
PRS Account Harvest Technologies
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP